Mechanisms of mindfulness in patients with migraine: Results of a qualitative study.

Probably not a substantial claim: may not pass S3 (load-bearing).

A master codebook was created until meaning saturation was reached.

“A master codebook was created until meaning saturation was achieved.24”

• cites [24] sourcePartly supported

  The Method sections (pages unavailable in our copy) describe creating a codebook and refining it through all 25 interviews. They assess meaning saturation separately for individual codes, rather than saying the codebook was created until meaning saturation was achieved. The Discussion notes that some code dimensions were still emerging at 25 interviews. (LLM, conf=0.87)

  Experimental — accuracy not yet measured

Classified as probably not a substantial claim.

A previous narrative review by the authors proposed four mechanisms by which mindfulness might affect migraine: changing pain perception, increasing interoceptive awareness, regulating autonomic dysfunction, and improving cognitive pain modulation.

“We previously published a narrative review discussing potential mechanisms of mindfulness in migraine, which included: (1) alterations in pain perception via de-coupling the sensory and affective components of pain; (2) enhanced interoceptive body awareness; (3) regulation of autonomic dysfunction seen in patients with migraine; and (4) improved cognitive modulation of pain.2”

• cites [2] sourceSupported

May combine two claims.

The authors' earlier clinical trials found clinically meaningful improvements in headache-related disability, pain catastrophizing, headache self-efficacy, and depressive symptoms, lasting up to 36 weeks.

“Our quantitative results from our clinical trials showed meaningful clinical improvements in headache-related disability, pain catastrophizing, headache self-efficacy, and depressive symptoms, with benefits seen out to 36 weeks.9, 10”

• cites [9] sourceNot checked — no full text of the source
• cites [10] sourceSupported

Probably not a substantial claim: may not pass S3 (load-bearing).

Researchers worldwide are actively investigating the neurobiological mechanisms of mindfulness.

“The neurobiological mechanisms of mindfulness are actively being explored by researchers across the world.12, 13”

• cites [12] sourcePartly supported

  The Introduction and section 5 describe an active field using neuroimaging and EEG to investigate the neural mechanisms of mindfulness, particularly mindfulness-based pain relief. The paper does not establish the claim's geographic qualifier that researchers are doing so “across the world.” (LLM, conf=0.82)

  Experimental — accuracy not yet measured
• cites [13] sourceNot checked — no full text of the source

May combine two claims.

In a prior trial, after MBSR, participants showed a 36% decrease in experimental heat pain intensity and a 30% decrease in pain unpleasantness.

“After MBSR, participants had a 36% reduction in response to experimental heat pain intensity and a 30% reduction in pain unpleasantness, suggesting a shift in pain perception that may alter migraine experience.10”

• cites [10] sourceSupported

Probably not a substantial claim: may not pass S3 (load-bearing).

Pain can be isolating, especially for people with sensory hypersensitivities that prevent full engagement in life activities, as in migraine.

“Pain can be isolating,38 especially for those with sensory hypersensitivities that preclude full engagement in life activities, such as in migraine.14”

• cites [38] sourceCould not verify

  Citation 14 is attached to the clause about sensory hypersensitivities limiting life activities in migraine; the preceding statement that pain can be isolating has a different citation. The sections “How Mindfulness Modulates the Insula” and “Interoception: Historical and Contemporary Conceptualization” discuss pain perception and distressing bodily sensations, but do not address that clause. Searches for migraine, sensory hypersensitivity, and limits on activities found no supporting passage in our copy. (LLM, conf=0.76)

  Experimental — accuracy not yet measured
• cites [14] sourcePartly supported

  The Results and Discussion (pages unavailable) report that migraine restricts social and valued life activities, while the Conclusion lists light and sound sensitivity as typical migraine symptoms. The paper does not establish that sensory hypersensitivities are what prevent full engagement in those activities; it attributes the described avoidance chiefly to fear of attacks or triggers. The separate citation attached to the sentence’s general statement that pain can be isolating is not assessed here. (LLM, conf=0.82)

  Experimental — accuracy not yet measured

Probably not a substantial claim: may not pass S3 (load-bearing).

Mindfulness meditation has been shown to reduce the subjective pain experience in healthy controls.

“While mindfulness meditation has been shown to attenuate the subjective pain experience in healthy controls,31, 32”

• cites [31] sourceNot checked — no full text of the source
• cites [32] sourceSupported

May combine two claims.

Mindfulness teaches turning toward pain rather than away from it, encouraging awareness of different sensations with curiosity and non-judgment, which ultimately allows cognitive pain reappraisal.

“Mindfulness specifically teaches “turning towards” pain rather than away from it, encouraging awareness of different sensations with curiosity and non-judgment, ultimately allowing for cognitive pain reappraisal.30 36, 37”

• cites [30] sourceNot checked — no full text of the source
• cites [36] sourceNot checked — no full text of the source
• cites [37] sourcePartly supported

  In “Integrating my body” (page not provided), the paper says mindfulness-based therapies encourage non-judgmental awareness, openness, curiosity, and acceptance of experiences such as pain. That supports attending to pain rather than avoiding it, but the passage does not specify awareness of different sensations or say that this ultimately enables cognitive pain reappraisal. (LLM, conf=0.84)

  Experimental — accuracy not yet measured

May combine two claims.

Participants described mindfulness skills as helping them notice their stress response sooner and use MBSR techniques to reduce stress reactivity, a commonly identified migraine trigger.

“Participants described mindfulness skills as allowing them to become aware of their stress response sooner and using MBSR techniques to decrease their stress reactivity, a commonly identified migraine trigger.41”

• cites [41] sourcePartly supported

  The Results report reduced emotional tension after meditation, and the Discussion says negative affect can precede a migraine attack. But the Method describes a single Buddhist loving-kindness meditation session with before-and-after ratings, not MBSR or participant accounts of noticing stress responses sooner and using techniques to change their reactivity. No page numbers were available in our copy. (LLM, conf=0.86)

  Experimental — accuracy not yet measured

Classified as probably not a substantial claim. May combine two claims.

Historically, increased body awareness was thought to cause somatosensory amplification and hypervigilance toward pain, worsening anxiety sensitivity and creating a maladaptive response.

“Historically, increased body awareness was thought to lead to somatosensory amplification and hypervigilance towards pain, worsening anxiety sensitivity and creating a maladaptive response.25”

• cites [25] sourcePartly supported

  The Introduction (page unavailable) says earlier literature associated body awareness with somatosensory amplification and commonly viewed it as maladaptive. The Measures section (page unavailable) distinguishes anxiety-related hypervigilance toward pain from mindful awareness. Neither passage says increased body awareness worsens anxiety sensitivity or establishes the causal sequence in the claim. (LLM, conf=0.86)

  Experimental — accuracy not yet measured

May combine two claims.

Interoceptive awareness localizes to the insula, a brain area considered a hub of activity in migraine that plays a key role in integrating sensory, autonomic, cognitive, and emotional processes.

“Interoceptive awareness localizes to the insula,39 an area of the brain considered a “hub of activity” in migraine, playing a key role in integrating many of the dynamic processes of migraine (sensory, autonomic, cognitive, and emotional).40”

• cites [39] sourceSupported
• cites [40] sourceCould not verify

  Citation 40 is attached to the claim that the insula is a migraine activity hub integrating sensory, autonomic, cognitive, and emotional processes. The Introduction and Discussion address migraine stimuli, perceived triggers, and stress-related autonomic effects, but our copy does not address the insula or its proposed integrative role. Searches for the insula, interoceptive awareness, and the stated processes found no relevant passage; citation 39, not this source, is attached to the separate localization claim. (LLM, conf=0.76)

  Experimental — accuracy not yet measured

May combine two claims.

Reductions in pain intensity from mindfulness-based pain relief are associated with heightened activity in the anterior cingulate cortex, anterior insula, and orbitofrontal cortex, while reductions in pain unpleasantness are associated with attenuated thalamus activity.

“The neural mechanisms of mindfulness-based pain relief have demonstrated that reductions of pain intensity are associated with heightened activity of the anterior cingulate cortex, the anterior insula, and the orbitofrontal cortex, while reductions in pain unpleasantness are associated with attenuated activity of the thalamus.32”

• cites [32] sourcePartly supported

  Split into 2 atoms — 1 confirmed, 1 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.

  Experimental — accuracy not yet measured

May combine two claims.

These qualitative findings expand understanding of how mindfulness may positively affect adults with migraine and help explain and validate previously reported quantitative findings.

“These qualitative findings expand our understanding of the mechanisms through which mindfulness may positively impact adults with migraine and help explain and validate our quantitative”

• cites [9] sourceNot checked — no full text of the source
• cites [10] sourceSupported

May combine two claims.

Group mindfulness sessions have been found to induce a state of mindfulness more effectively and strengthen social connectivity more than solitary sessions.

“Group mindfulness sessions have been found to more effectively induce a state of mindfulness and strengthen social connectivity compared to solitary sessions,48”

• cites [48] sourcePartly supported

  The Results (State Mindfulness and Social Connection; page not provided) report significantly greater social connectedness after video-guided group meditation than after solitary meditation. They found no significant difference in state mindfulness between those conditions (p = .77), so the claim that group sessions induced mindfulness more effectively is not supported. The study tested simulated settings with novice meditators, rather than group sessions generally. (LLM, conf=0.93)

  Experimental — accuracy not yet measured

May combine two claims.

In the authors' quantitative results, mindfulness produced a 30% reduction in experimental pain unpleasantness and a 36% reduction in experimental pain intensity in participants with migraine.

“In our quantitative results, we found that mindfulness resulted in a shift in pain perception, with a 30% and 36% reduction in experimental pain unpleasantness and intensity, respectively, in participants with migraine.10”

• cites [10] sourceSupported

May combine two claims.

Although MBSR is taught in a group setting and may moderate mindfulness benefits, the authors' quantitative results showed that the mindfulness group had an impact beyond the Headache Education comparator, suggesting the group effect was not the only mechanism explaining clinical benefits.

“our quantitative results demonstrated the impact of the mindfulness group beyond our comparator Headache Education group, suggesting the group effect was not the sole mechanism explaining clinical benefits.10”

• cites [10] sourceSupported

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Many prior models have been developed to understand the mechanisms of mindfulness, and these are summarized in a review.

“A multitude of prior models have been developed to understand the mechanisms of mindfulness, which are well-summarized in this review.24”

• cites [24] sourceCould not verify

  The Introduction’s Study Aims and the Results sections address saturation in qualitative interviews, not mindfulness. Searches for mindfulness models and reviews of mindfulness mechanisms found no passage in our copy addressing the attributed claim. Page numbers were not available. (LLM, conf=0.78)

  Experimental — accuracy not yet measured

May combine two claims.

Increased embodied interoceptive awareness may reduce the experience that the body has betrayed the person, allowing positive benefits of interoception.

“This increased embodied interoceptive awareness may decrease the experience commonly seen in those with chronic pain that the body has “betrayed them,”38 allowing for positive benefits of interoception.”

• cites [38] sourcePartly supported

  In “Open Monitoring or Mindfulness” (page unavailable), the paper says mindful attention can help people with histories of abuse or trauma come to experience their bodies as helpful rather than threatening. “Attentional Style” (page unavailable) likewise discusses learning to experience the body as safe and trustworthy. These passages support the proposed shift in bodily experience, but they do not establish that feeling betrayed by the body is common in chronic pain or that increased awareness reduces that specific experience. (LLM, conf=0.85)

  Experimental — accuracy not yet measured

Probably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing).

During the COVID-19 pandemic, with elevated stress and uncertainty, mindfulness may be an especially beneficial treatment approach for people with migraine.

“In the midst of the COVID-19 pandemic with elevated stress and uncertainty, mindfulness may be an especially beneficial treatment approach for those with migraine.53”

• cites [53] sourcePartly supported

  The Discussion reports that a single online mindfulness session immediately reduced stress, anxiety, and COVID-related concern in patients with migraine. It also says effects were similar across migraine patients, healthcare workers, and the general public; the Results (Exploratory Analyses) found no statistically significant difference between groups. The paper therefore supports possible benefit for people with migraine, but not the suggestion that they benefit especially. (LLM, conf=0.84)

  Experimental — accuracy not yet measured

May combine two claims.

Participants used mindfulness both as an acute treatment and as a preventive treatment for migraine, enabling them to take medications sooner or avoid them.

“Participants used mindfulness as both an acute and prophylactic migraine treatment, allowing them to take medications earlier or avoid them altogether.”

• Also stated in: § Results: · plain

  “Although taught as a prevention, mindfulness was used both acutely and prophylactically.”

May combine two claims.

Participants felt less isolated by migraine and experienced the creation of a safe space.

“Participants experienced feelings of decreased migraine isolation and creation of a “safe space.””

May combine two claims.

Interoceptive awareness of the body and thoughts developed, with greater sensitivity to interoceptive signals, embodied awareness, and meta-cognition.

“Interoceptive awareness of the body and thoughts developed with increased sensitivity to interoceptive signals with embodied awareness and meta-cognition”

May combine two claims.

In patients with migraine, learning mindfulness improved emotion regulation, including greater migraine acceptance, hope, empowerment, and self-efficacy.

“Learning mindfulness also altered the relationship to migraine disease through increased emotion regulation with migraine acceptance, hope, empowerment, and self-efficacy (Table 4B).”

May combine two claims.

Greater sensitivity to interoceptive signals led to earlier recognition of migraine attacks, which changed how participants used medications.

“Specifically, increased sensitivity to interoceptive signals led to earlier awareness of migraine attacks, which altered medication use.”

May combine two claims.

After learning mindfulness, participants' heat pain testing experience changed, showing altered pain perception and reduced reactivity to pain.

“After learning mindfulness, participants’ experience during heat pain testing changed, with alterations in pain perception and decreased reactivity to pain (Table 3).”

May combine two claims.

Mindfulness increased participants' use of the breath as an anchor, which led to non-reactivity.

“increased the use of breath as an anchor leading to non-reactivity.”

May combine two claims.

Meaningful behavior changes occurred, including improved eating and drinking habits, activity level, and sleep hygiene.

“Meaningful behavior changes were seen through improved eating and drinking habits, activity level, and sleep hygiene.”

May combine two claims.

Cognitive well-being increased, as shown by awareness of mind-body integration and clearer thinking.

“Increased cognitive well-being was seen through awareness of mind-body integration and being able to think more clearly.”

May combine two claims.

Inter-ictal self-blame, guilt, and stigma decreased, while migraine acceptance, hope, empowerment, self-efficacy, and self-compassion increased.

“Inter-ictal factors of self-blame, guilt, and stigma decreased while migraine acceptance, hope, empowerment, self-efficacy, and self-compassion increased.”

May combine two claims.

Emotional well-being improved, as shown by enjoyment and happiness, equanimity, reduced depressive symptoms and anxiety, and prioritizing and accepting time for self-care.

“Improvement in emotional well-being was seen through enjoyment and happiness, equanimity (mental calmness and ability to relax), improved depressive symptoms and anxiety, and prioritizing and accepting time for self-care.”

May combine two claims.

Non-judgmental attitudes increased, including self-acceptance, acceptance of life stressors, and self-compassion.

“Non-judgmental attitudes, such as self-acceptance, acceptance of life stressors, and self-compassion, also increased.”

May combine two claims.

Emotion regulation improved, with enhanced emotional insight, reduced emotional reactivity, earlier stress-body awareness, and improved stress response.

“Emotion regulation improved, with enhanced emotional insight, downregulation of emotional reactivity, earlier stress-body awareness (with sensitivity to stress interoceptive signals), and improved stress response.”

May combine two claims.

Patients with migraine who learned mindfulness through MBSR incorporated mindfulness into daily life and became more aware of external and internal experiences.

“infusion of mindfulness skills in daily life with increased awareness of external and internal experiences (Table 5)”

• Also stated in: § Results: · plain

  “increased awareness of external and internal experiences”

May combine two claims.

Mindfulness led to earlier awareness of stress in the body and increased interoceptive awareness, resulting in earlier recognition of attacks and earlier, more effective management.

“Mindfulness resulted in earlier stress-body awareness and increased interoceptive awareness resulting in earlier attack recognition, leading to earlier and more effective management.”

• Also stated in: § Conclusions: · plain

  “Increased stress-body and interoceptive awareness resulted in earlier migraine awareness and treatment.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Participants averaged 44 years of age, were mostly women (92%), White (89%), and had private health insurance (87%).

“Participants in both the pilot and larger study were an average of 44 (SD=13.0) years old, mostly women (92%), White (89%), and had private health insurance (87%) (Table 1).”

May combine two claims.

Participants' response to migraine attacks changed due to increased interoceptive awareness and improved emotion regulation during attacks.

“Participants’ response to migraine attacks changed through increased interoceptive awareness (conscious perception of internal body sensations)25 and improved emotion regulation during migraine attacks (Table 4A).”

May combine two claims.

Participants experienced self-compassion during attacks and greater pain acceptance, with less self-blame, guilt, and stigma.

“Participants experienced self-compassion during attacks and increased pain acceptance with less self-blame, guilt, and stigma.”

May combine two claims.

Participants gained a better understanding of their migraine pain and could differentiate between pain intensity and unpleasantness through heat pain testing.

“In addition, participants had a better understanding of their migraine pain and of the differentiation between pain intensity and unpleasantness through heat pain testing (Table 3).”

May combine two claims.

Participants reported greater patience with themselves and others and improved listening skills.

“Participants reported being more patient with themselves and others as well as improved listening skills.”

May combine two claims.

Patients with migraine who learned mindfulness through MBSR showed changes in their response to migraine attacks and their relationship with migraine disease.

“altered response to migraine attacks and relationship to migraine disease (Table 4)”

• Also stated in: § Results: · plain

  “altered response to migraine attacks and disease”

May combine two claims.

Most participants had a 26-year history of migraine, with 9.8 headache days per month, 6.6 migraine days per month, and high baseline disability (HIT-6 score 63.0).

“Most participants had a 26 (SD=14.0) year history of migraine, with 9.8 (3.3) headache days/month, 6.6 (2.7) migraine days/month, and high disability at baseline (HIT-6 score of 63.0, SD 7.2).”

May combine two claims.

In this study, recognizing a potential migraine earlier allowed participants to prepare for or avoid the attack altogether, often using breathing and relaxation techniques learned through MBSR.

“In our study, identifying a potential migraine earlier even allowed participants to prepare for, or avoid, the attack altogether, often using breathing and relaxation techniques learned through MBSR.”

Classified as probably not a substantial claim. May combine two claims.

Use of the breath as an anchor was reported throughout many interviews and appeared in various themes and subthemes.

“Use of the breath as an anchor was reported throughout many interviews and can be found in various themes and subthemes”

May combine two claims.

Participants reported that mindfulness reduced inter-ictal self-blame, guilt, and stigma while increasing migraine acceptance, hope, empowerment, self-efficacy, and self-kindness during attacks.

“Participants highlighted how mindfulness decreased inter-ictal factors of self-blame, guilt, and stigma, while also increasing migraine acceptance, hope, empowerment, self-efficacy, and self-kindness during attacks.”

May combine two claims.

Breath awareness played a key role in understanding migraine and stress, helping decrease stressors by leading to earlier stress-body awareness, non-reactivity, and avoidance of medications.

“Breath awareness played a key role in understanding migraine and stress, helping decrease stressors by leading to earlier stress-body awareness, non-reactivity, and avoidance of medications.”

May combine two claims.

The authors' study identified the group experience as beneficial for connecting people with migraine, reducing migraine isolation, developing group support and empowerment, improving migraine perspective, and creating a safe space.

“Our study identified the group experience as beneficial to connecting people with migraine to each other, decreasing migraine isolation, developing a sense of group support and empowerment, improving migraine perspective, and creating a safe space.”

Probably not a substantial claim: may not pass S3 (load-bearing).

A semi-structured interview guide with mostly open-ended questions was used.

“A semi-structured interview guide was utilized during qualitative interview sessions, which contained mostly open-ended questions (see supplementary materials).”

Probably not a substantial claim: may not pass S3 (load-bearing).

The pilot study did not reach its target sample size of 34.

“For the pilot study, the goal sample size of 34 was not reached (time constraints unrelated to the feasibility of the study [e.g., REW’s relocation] limited recruitment to 3 months and decreased the ability to reach the target sample size).9”

Classified as probably not a substantial claim.

UCNS-certified headache physicians conducted in-person evaluations to confirm ICHD migraine diagnoses.

“UCNS-certified headache physicians conducted in-person evaluations to confirm International Classification of Headache Disorders (ICHD) migraine diagnoses.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

A qualitative data expert provided training, consultation, and participated in team meetings.

“The qualitative data expert provided educational training, consultation, and participation in team meetings.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Students were educated on qualitative interview techniques and analysis using materials such as The Coding Manual for Qualitative Research.

“All students were educated on qualitative interview techniques and analyses using educational materials such as the textbook The Coding Manual for Qualitative Research,18 with regularly assigned readings reviewed (for further details, see Estave et al,14).”

• cites [18] sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing).

The larger trial's sample size was estimated at 44 per group to achieve at least 90% power with an alpha of 0.05.

“For the larger randomized clinical trial, we estimated a final sample size of 44 per group to provide at least 90% power with an alpha of 0.05 (using PASS statistical software).10”

Probably not a substantial claim: may not pass S3 (load-bearing).

All interviews were recorded and transcribed verbatim.

“All interviews were recorded and transcribed verbatim.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Interviews from the larger study averaged 47 minutes (SD 13.9), ranged from 18 to 77 minutes, and totaled nearly 3300 minutes.

“The interviews from the entire larger study (n=71) lasted on average 47 min (SD 13.9) with a range of 18–77 min and a total of nearly 3300 min of recorded interviews.14”

Probably not a substantial claim: may not pass S3 (load-bearing).

Themes, subthemes, and the conceptual model were continually discussed to enhance theoretical sensitivity and researcher reflexivity.

“Additionally, themes, subthemes, and the conceptual model were continually discussed to increase awareness of theoretical sensitivity and facilitate reflexivity of the researchers.”

Probably not a substantial claim: may not pass S3 (load-bearing).

The qualitative interview training included probing techniques to clarify details without leading participants.

“Qualitative interview techniques that were taught included appropriate probing techniques to clarify details without leading participants.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Of the 12 participants not interviewed in the larger study, 4 were lost to follow-up, 4 withdrew, and 4 were not interviewed during their 12-week visit.

“Of the 12 participants not interviewed in the larger study, 4 were lost to follow up, 4 withdrew from the study, and 4 were not interviewed during their 12 week study visit.10”

Probably not a substantial claim: may not pass S3 (load-bearing).

An audit trail was maintained throughout data analysis.

“An audit trail was maintained throughout the entirety of data analysis with notes from each research team meeting, within Dedoose software, and through use of an online Sharepoint team site (maintained with high security behind a HIPAA compliant firewall) to organize and maintain study files (e.g., framework matrices, etc.).”

Probably not a substantial claim: may not pass S3 (load-bearing).

Data interpretation included content expertise in mindfulness clinical trials, behavioral interventions, and qualitative interviewing.

“For data interpretation, content expertise included those with mindfulness clinical trial expertise (REW and PG), behavioral intervention expertise (ES) and qualitative interviewing expertise (PG and ES).”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

The students were thoroughly trained in qualitative data analysis and were not experts in mindfulness, migraine, or qualitative data.

“These students were thoroughly trained in qualitative data analysis as described above and were not mindfulness, migraine, or qualitative data experts.”

May combine two claims.

Patients with migraine who learned mindfulness through MBSR developed greater mindful awareness of internal and external experiences, with shifts in pain perception and migraine experiences that resulted in improved overall well-being.

“Participants with migraine who learned mindfulness techniques through MBSR developed increased mindful awareness of internal and external experiences, with shifts in pain perception and migraine experiences resulting in improvement in overall well-being.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Coding, categorization, discussion, and disagreement resolution continued iteratively until all team members agreed on the final themes, subthemes, and table organization.

“An iterative process of coding, categorization, discussion, and disagreement resolution continued until all team members agreed on a final set of themes, subthemes, and table organization.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Investigator triangulation was achieved for 50% of transcripts until a consistent technique was established.

“Investigator triangulation23 was achieved for 50% of the transcripts until a consistent technique was established.”

• cites [23] sourceNot checked — no full text of the source

May combine two claims.

Receiving the intervention in a group context allowed participants with migraine to connect with others facing similar challenges, which reduced migraine isolation and increased mindfulness motivation and accountability.

“Receiving the intervention in a group context provided an opportunity for participants with migraine to connect with others experiencing similar challenges, resulting in decreased feelings of migraine isolation and increased mindfulness motivation and accountability.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Participants continued their migraine medications during the study and were blinded to group assignment.

“Participants remained on their migraine medications for the study duration and were blinded to group assignment.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Pain intensity and unpleasantness were measured with a 15 cm sliding Visual Analogue Scale (VAS).

“Both intensity and unpleasantness were measured using a 15 cm sliding Visual Analogue Scale (VAS), ranging from “no pain sensation” to “most intense imaginable” and from “not at all unpleasant” to “most unpleasant imaginable,” respectively.15, 16”

• cites [15] sourceNot checked — no full text of the source
• cites [16] sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing).

Team members received weekly training in qualitative data analysis over 6 months.

“Under the leadership of a qualitative research specialist (from Wake Forest Qualitative and Patient-Reported Outcomes Developing Shared Resource), team members who were not mindfulness experts (undergraduate, masters, and MD/PhD students, n = 7) received weekly training in qualitative data analysis over 6 months.”

Probably not a substantial claim: may not pass S3 (load-bearing).

All participants provided written informed consent before participating.

“All participants gave written informed consent prior to participation.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Six independent coders applied the codebook to each transcript.

“The codebook was applied to each transcript by six independent coders.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

One-third of interviews were assessed by two independent raters, with inter-rater reliability tests to confirm consistency.

“One-third of the interviews were assessed by two independent raters, with inter-rater reliability tests conducted to confirm consistency.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Experts in qualitative interviewing, mindfulness, and/or behavioral interventions were included to help interpret results.

“Experts in qualitative interviewing, mindfulness, and/or behavioral interventions (ES and PG) were then included to help interpret results.”

Probably not a substantial claim: may not pass S3 (load-bearing).

All final summaries were cross-checked against the original transcripts for accuracy.

“All final summaries were cross-checked against the original transcripts to ensure accuracy.”

May combine two claims.

Learning mindfulness skills changed participants' perspectives and altered their experiences with the world and with migraine attacks.

“Learning mindfulness skills changed participants’ perspectives, altering their experiences with the world and with migraine attacks.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

The study was registered at clinicaltrials.gov (NCT01545466 and NCT02695498) and received IRB approvals.

“We conducted semi-structured in-person qualitative interviews from participants with migraine from two randomized clinical trials on MBSR9, 10 (n=43) registered at clinicaltrials.gov (NCT01545466 and NCT02695498) with IRB approvals from Brigham and Women’s Hospital and Wake Forest School of Medicine, respectively.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Expert qualitative interview consultants trained team members to conduct effective, unbiased qualitative interviews.

“Expert qualitative interview consultants from the Wake Forest University School of Medicine Qualitative and Patient-Reported Outcomes (Q-Pro) Shared Resource provided educational training, consultation, and resources to all team members on how to appropriately conduct effective un-biased qualitative interviews.”

Probably not a substantial claim: may not pass S3 (load-bearing).

The PI used theoretical sensitivity throughout data analysis and interpretation.

“Given the PI’s expertise in mindfulness, the PI was able to identify and recognize meaningful data relevant to the themes and conceptual model during data analysis and interpretation, thus employing theoretical sensitivity throughout the process.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

In the larger study, 73.3% of those randomized to MBSR completed qualitative interviews, giving an overall response rate of 78.2% across both studies.

“Of those randomized to MBSR in the larger study, 73.3% (33/45) completed qualitative interviews, making the total response rate of participants completing qualitative interview in both studies 78.2% (43/55).”

Classified as probably not a substantial claim.

Themes and subthemes were identified using Charmaz's hypothesis-free, constructivist grounded theory approach.

“Themes and subthemes were identified using Charmaz’ hypothesis-free, constructivist grounded theory approach.17”

• cites [17]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Probably not a substantial claim: may not pass S3 (load-bearing).

All participants randomized to MBSR in the pilot study completed qualitative interviews.

“One hundred percent of those randomized to MBSR completed qualitative interviews.”

May combine two claims.

Interoceptive and stress-body awareness increased, with overall improved migraine management.

“Interoceptive and stress-body awareness increased, with overall improved migraine management.”

May combine two claims.

The results highlight the importance of the biopsychosocial model, with biological, psychological, and social factors all contributing to altered pain and migraine experiences.

“These results also highlight the importance of the biopsychosocial model, with biological (awareness), psychological (well-being) and social (group) factors all playing a role in the altered pain and migraine experiences.”

May combine two claims.

Increased interoceptive awareness led participants to recognize migraine attacks and triggers earlier, resulting in earlier medication use.

“The increased interoceptive awareness experienced by participants led to earlier awareness of migraine attacks (e.g., during prodromal state) and triggers, resulting in earlier use of medications.”

Classified as probably not a substantial claim.

Rigorous qualitative methodology was used to capture, organize, and analyze the data.

“Rigorous qualitative methodology was used to effectively capture, organize, and analyze data.”

Classified as probably not a substantial claim. May combine two claims.

Previous research hypothesized mechanisms of mindfulness through survey responses, whereas this study captured mechanisms through participants' voices and lived experiences after learning mindfulness in a standardized MBSR course.

“While previous research has hypothesized mechanisms of mindfulness through survey responses, this study captured mechanisms through the voices and lived experiences of the participants who had experientially learned mindfulness during a standardized MBSR course.”

Classified as probably not a substantial claim.

The authors' conceptual model framework organizes the main findings to help understand the major factors potentially contributing to altered pain perception and migraine attack experiences.

“Our conceptual model framework (Figure 1) organizes our main findings to better understand the major factors potentially contributing to altered pain perception and experiences with migraine attacks.”

May combine two claims.

Learning mindfulness can serve as a pharmacological adjunct and may lead to better medication management.

“this finding demonstrates that learning mindfulness can be used as a pharmacological adjunct and may result in better medication management.”

May combine two claims.

The group setting of MBSR allows dialogue, inquiry, and didactic discussion, giving participants an opportunity to learn how to use mindfulness skills in daily life.

“The group setting of MBSR allows for dialogue, inquiry, and didactic discussions, providing an opportunity to learn how to use mindfulness skills in the context of daily life experiences.”

May combine two claims.

Psychologically focusing on the breath may physiologically activate the vagus nerve, which has been shown to be an effective acute migraine treatment with the non-invasive vagus nerve stimulator.

“Psychologically focusing on the breath may physiologically activate the vagus nerve, which has been demonstrated to be an effective acute migraine treatment with the novel non-invasive vagus nerve stimulator.44”

• cites [44] sourceNot checked — no full text of the source

May combine two claims.

The study included a large sample of 43 qualitative interviews obtained across two clinical trials conducted in two different cities across time.

“including a large sample of 43 qualitative interviews, obtained across two clinical trials that were conducted in two different cities across time.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Group-based, in-person instruction distinguishes this intervention from many app-based programs that offer only asynchronous learning, experiential practices, or self-management strategies.

“The group-based, in-person instruction differentiates this intervention from many app-based programs that exclusively offer asynchronous learning, experiential practices, or self-management strategies.”

Classified as probably not a substantial claim.

Participants were diagnosed with migraine by a UCNS-certified headache specialist using ICHD diagnostic criteria.

“Participants were diagnosed with migraine by a UCNS-certified headache specialist using ICHD-diagnostic criteria.”

May combine two claims.

Mindfulness changed participants' migraine pain experience by altering awareness, perspective, and reactivity, which improved their ability to distinguish pain intensity from unpleasantness.

“Mindfulness impacted participants’ migraine pain experience by changing their awareness, perspective, and reactivity, leading to an improved ability to differentiate pain intensity from unpleasantness.”

Classified as probably not a substantial claim.

The use of open-ended questions allowed participants' perspectives to be depicted authentically.

“The use of open-ended questions allowed for participants’ perspectives to be depicted authentically.”

Probably not a substantial claim: may not pass S3 (load-bearing).

MBSR is limited to people with the time, energy, and financial resources to pay for the sessions.

“MBSR is limited to those with the time, energy, and financial resources to pay for the sessions.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

MBSR involves weekly group sessions with a guided teacher and home practice of 30 minutes per day on days practiced; results may not generalize to other mindfulness interventions or lower dosages.

“MBSR involves weekly group sessions with a guided teacher, and participants practiced mindfulness at home over 30 minutes per day on the days practiced; results may not generalize to other mindfulness interventions or lower dosages.”

May combine two claims.

Participants in the two trials had either 4-14 or 4-20 migraine days per month, were treatment-seeking, and had baseline severe headache-related disability; therefore, the results reflect MBSR's impact in patients with this disease burden.

“Participants in the two trials had either 4–14 or 4–20 migraine days/month, were treatment-seeking, and had baseline severe headache-related disability; therefore, the results reflect the impact of MBSR in patients with this disease burden.”

Probably not a substantial claim: may not pass S3 (load-bearing).

The authors did not capture effect sizes of the different variables in the model.

“We did not capture effect sizes of the different variables in the model.”

May combine two claims.

The study had a non-diverse patient population, as most participants were White educated females, which decreases generalizability.

“Limitations of this study include a non-diverse patient population, as most participants were White educated females, decreasing study generalizability.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Inter-individual differences may exist, as the role each factor plays for each person may be greater, lesser, or absent.

“Inter-individual differences may exist, as the role each factor plays for each person may be more, less, or not at all.”

May combine two claims.

In the two clinical trials, 78% of those randomized to MBSR completed the qualitative interviews, so the results reflect only the responses of interview completers.

“In the two clinical trials, 78% randomized to MBSR completed the qualitative interviews, so results only reflect responses of those who completed the interview.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Interviews were conducted immediately after the intervention, when the perspective on mindfulness' impact may have been greatest, and effects seen may wane over time.

“interviews were conducted immediately after the intervention when the perspective on mindfulness’ impact may have been greatest and effects seen may wane over time.”

Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).

Gender, race, ethnicity, socioeconomic status, and other individual differences may influence the impact each factor has on mindfulness' mechanism in migraine.

“Furthermore, gender, race, ethnicity, socioeconomic status, and other individual differences may influence the impact each factor has on mindfulness’ mechanism on migraine.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

The conceptual model broadly hypothesizes effects seen across all participants, and each person may not experience each one.

“Our conceptual model broadly hypothesizes the effects seen across all participants, and each person may not experience each one.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Magnitude coding was not conducted to assess the proportion of participants endorsing themes because the overarching goal was to understand all potential mechanisms of mindfulness in migraine.

“Magnitude coding was not conducted to assess the proportion of participants endorsing the various themes as our overarching goal with these analyses was to understand all potential mechanisms that could play a role of mindfulness in migraine.”

Classified as probably not a substantial claim.

Inferences about potential mechanisms are based on patient perceptions.

“Additionally, inferences about potential mechanisms are based on patient perceptions.”