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Acupuncture and Reflexology for Insomnia: A Feasibility Study
Abstract
Objective: To assess the feasibility of patient recruitment and retention, logistics of intervention and outcome measure sensitivity for a study designed to investigate the use of acupuncture and reflexology for the management of insomnia. Design: Feasibility study for a randomised controlled trial. Setting: University of Ulster Clinic. Patients: Thirteen participants with sleep disturbances. Interventions: Participants were randomised to receive one of three treatments, either: acupuncture (n = 5), reflexology (n = 4) or music therapy (n = 4). These treatments were administered six times over a 3-week period. Main outcome measures: The Pittsburgh Sleep Quality Index (PSQI) and Short Form 36 version 2 (SF-36v2) were recorded at baseline, post-treatment and follow-up. Each participant also completed a Sleep Diary. Results: Ten participants completed treatment. In the acupuncture and reflexology groups, a clinically relevant improvement in two out of three participants was observed on the PSQI following treatment. Music therapy produced no clinically important improvements. This study has demonstrated the feasibility of conducting an RCT on the effect of acupuncture and reflexology in primary insomnia using PSQI as the primary outcome measure. Modifications for a more rigorous study design have been discussed. Results from such a study would address the lack of high-quality evidence for the effectiveness of such therapies.
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“A change of 3.0 is considered a clinically important difference in the PSQI score [30].”
From Online prenatal trial in mindfulness sleep management (OPTIMISM): Protocol for a pilot randomized controlled trial (2020) · cites this paper as [30]
In the citing paper
“Therefore, the effect of exercise on PSQI in favor of the intervention (low-quality evidence) was considered small.”
From Exercise can improve sleep quality: A systematic review and meta-analysis (2018) · cites this paper as Hughes et al., 2009
In the citing paper
“As to sleep quality, a three-point change in PSQI scores is considered indicative of a minimum clinically significant difference. ( 53 ) In this study, PSQI scores dropped by 3.17 points. Therefore, the positive effect of exercise on sleep quality (very low quality of evidence) was thought to be small.”
From Physical exercise as a therapeutic approach for adults with insomnia: Systematic review and meta-analysis (2022) · cites this paper as [53]
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“To characterize the discrepancy between behavioural sleep schedules and circadian preferences, a circadian preference misalignment index was calculated as the time difference between the sleep midpoint based on the actual bed and wake-up times reported on the PSQI, and the sleep midpoint based on preferred bed and wak…”
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“The minimal clinically important improvement in PSQI is − 3, 39 therefore this difference might not be clinically signi fi cant.”
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“A change of 3 points or more on the PSQI is considered a minimal clinically important difference [47].”
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“Since the minimal clinically important differences (MCIDs) of ISI and PSQI scores in people with insomnia are 6 and 3 points, respectively [43, 44], the mean reductions of 10.”
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“• Improvement in quality of sleep was defined as a decrease of 3 or more points in the PSQI compared to baseline.(21) • Satisfactory use of NIV was defined as a mean usage of ≥4 h/day in the 30 days preceding follow-up assessment.”
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“The minimal clinically significant improvement in PSQI is −3 [31], and we observed a change of −2.”
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“The MCID score indicating clinically significant improvement in a sample of patients with sleep disturbance was –3 (Hughes et al., 2009).”
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“A global PSQI score of greater than 5 yielded a diagnostic sensitivity of 89.6% and a specificity of 86.5% in identifying poor sleepers.24 A reduction of three or more points is considered the minimal clinically important difference (MCID) for the PSQI.25 The Chinese version of the Patient Health Questionnaire (PHQ) (…”
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“A reduction of 3 points on global PSQI is considere a clinically significant reduction [17,19,20], and it is noteworthy that all 5 participants alloca ted to receive either auricular therapy or selfacupressure had a reduction of 3 or more in global PSQI scores.”
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Cereset Research Standard Operating Procedures for Insomnia: A Randomized, Controlled Clinical Trial
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“Sleep quality measured by the PSQI had a statistically significant improvement in the intervention group at V3 compared to control, and met clinically meaningful criteria (3 point drop).(34) A unique feature of this study is that the control group was invited to cross over and receive the intervention with tones linke…”
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“In addition, improvement in PSQI did not exceed the minimal important difference (18).”
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“0 is considered a clinically important difference in the PSQI score [30].”
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“In our study we decided to consider a change of 3 or more points to indicate the minimum clinically significant difference, in accordance with Hughes [29].”
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“A minimal clinically important difference in the PSQI is a change in score of 3 or greater.(27) To evaluate sleep disturbance in further detail, a validated three‐factor scoring model was also used.”
MethodSleep quality and lymphedema in breast cancer survivors: a mixed method analysis
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“The accepted minimal clinically important difference for PSQI is considered a change of three points or more [41, 42].”
Loureiro, A. P. C., Burkot, J., Oliveira, J., & Barbosa, J. M. (2021) · Complementary Therapies in Clinical Practice · doi:10.1016/j.ctcp.2021.101523 · Cited by 10
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Androgen Deprivation and Sleep Disturbance
Myers, J. S., Siengsukon, C. F., Sherman, J., Shen, X., Ptomey, L. T., Montgomery, R. N., Bock, K. J., Rice, A. M., Parker, W. P., & Maliski, S. L. (2022) · Cancer Nursing · doi:10.1097/ncc.0000000000001100 · Cited by 10
Ughreja, R. A., Venkatesan, P., Gopalakrishna, D. B., Singh, Y. P., & Vani Lakshmi, R. (2024) · Journal of Chinese Integrative Medicine · doi:10.1016/j.joim.2024.06.003 · Cited by 10
Auckley, D. H., Mehra, R., Johnson, K. G., Billings, M. E., Carandang, G., Falck-Ytter, Y. T., Khayat, R., Mustafa, R. A., Peña-Orbea, C., Sahni, A. S., et al. (2025) · Journal of Clinical Sleep Medicine · doi:10.5664/jcsm.11866 · Cited by 9
Effects of Reflexology on Pain in Patients With Fibromyalgia
Korhan, E. A., Uyar, M., Eyigör, C., Yönt, G. H., & Khorshıd, L. (2016) · Holistic Nursing Practice · doi:10.1097/hnp.0000000000000178 · Cited by 9
McVicar, A. J., Greenwood, C., Ellis, C., & LeForis, C. (2016) · The Journal of Alternative and Complementary Medicine · doi:10.1089/acm.2016.0015 · Cited by 8
El-Solh, A., Lawson, Y., Martinson, A. A., & Wilding, G. E. (2025) · Psychiatric Quarterly · doi:10.1007/s11126-025-10143-9 · Cited by 7
“Assuming a correlation coefficient of 0.7 between pre-and post-treatment [40 ], 21 patients per arm were needed to achieve 80% power at a significance level of 5% in order to detect a clinically significant difference of 3 units in PSQI [ 41].”
InfluentialEvaluation of a tactile breath pacer for sleep problems: A mixed method pilot study
Vermeylen, S., Honinx, E., Broes, S., Vandenhoudt, H., & Witte, N. A. J. D. (2022) · Frontiers in Digital Health · doi:10.3389/fdgth.2022.908159 · Cited by 7
“The Pittsburgh Sleep Quality Index (PSQI) is a validated self-assessment questionnaire that assesses sleep quality and frontiersin.org FIGURE 1 The Moonbird breath pacer, including a PPG sensor (right picture).”
BackgroundInfluentialBanaei, M., Alizadeh, S., Roozbeh, N., Naz, M. S. G., Taghvaei, E., Parviz, L., & Ghasemi, V. (2025) · BMC Public Health · doi:10.1186/s12889-025-25142-5 · Cited by 6
Mahajan, A., Mahajan, S., & Tilekar, S. D. (2021) · Journal of Aging and Physical Activity · doi:10.1123/japa.2020-0207 · Cited by 6
Shao, C., Lin, L., Chen, M., Wang, N., & Shangguan, W. (2023) · BMC Anesthesiology · doi:10.1186/s12871-023-02109-w · Cited by 6
“The PSQI has a minimum clinically important difference (MCID) of ≥ 3 [18], so we chose 3 scores as the estimated variability between the two groups.”
MethodTakemura, N., Cheung, D. S. T., Fong, D., & Lin, C. (2023) · Palliative & Supportive Care · doi:10.1017/s1478951523000962 · Cited by 6
“We assessed the association of attendance, compliance with home-based practice, and perceived satisfaction with sleep improvement at 4 and 12 months, defined as a change in PSQI that reached the MCID of at least 3 points, through logistic regression.”
Pépin, J., Benjafield, A., Munt, O., Woehrle, H., Heinzer, R. C., Arzt, M. E., & for the READ-ASV Investigators (2025) · Journal of Clinical Sleep Medicine · doi:10.5664/jcsm.11652 · Cited by 5
“30 The EQ-5D includes 5 items that are each rated from 1 – 5 (1 meaning no problems and 5 meaning severe problems).”
Cognitive behavioural therapy for insomnia in people with cancer
Cai, Z., Tang, Y., Liu, C., Li, H., Zhao, G., Zhao, Z., & Zhang, B. (2025) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd015176.pub2 · Cited by 6
Teriparatide Plus Zoledronic Acid for Osteogenesis Imperfecta
Hald, J. D., Weir, C. J., Keerie, C., Dewar, L., MacLean, M., Milne, L., Keen, R. W., Walsh, J., Poole, K. E. S., Langdahl, B. L., et al. (2026) · JAMA · doi:10.1001/jama.2026.6889 · Cited by 5
Stavrou, V. T., Vavougyios, G. D., Tsirimona, G., Boutlas, S., Santo, M., Hadjigeorgiou, G. M., Bargiotas, P., & Gourgoulianis, K. I. (2025) · Applied Sciences · doi:10.3390/app15052532 · Cited by 6
Onabotulinumtoxin A Improves Psychological Aspects in Chronic Migraine Patients
Al-Hashel, J., Ashkanani, H. K. A. H. A., Almutairi, O., Bokubar, F., Mubarak, S., Alwazzan, S., Alroughani, R., Youssry, D., & Ahmed, S. F. (2021) · Frontiers in Neurology · doi:10.3389/fneur.2020.633355 · Cited by 5
“On the other hand, a reduction by ≥3-point in the total PSQI score was considered a clinically meaningful improvement (22).”
BackgroundCao, S., Xin, B., Yu, Y., Cheng, P., Zhu, C., Deng, M., Gao, X., Chu, J., & Liu, T. (2023) · World Journal of Surgical Oncology · doi:10.1186/s12957-023-02895-0 · Cited by 5
“Additionally, an improvement in the global PSQI score of ≥ 3 points was considered a minimal clinically important difference [20].”
BackgroundDrozd, C., Curtit, E., Jacquinot, Q., Roux, P., Paget‐Bailly, S., Gillet, V., Méneveau, N., & Mougin, F. (2026) · Breast Cancer Research and Treatment · doi:10.1007/s10549-026-07923-7 · Cited by 4
“For the ISI, PSQI, and MFI-20 questionnaires, a Minimally Clinically Important Difference (MCID) was defined respectively as ≥ 6 points [23], ≥ 3 points [24] and ≥ 2 points.”
Papavero, L., Wilke, J., Ali, N., Schawjinski, K., Holtdirk, A., & Schöller, K. (2024) · Brain and Spine · doi:10.1016/j.bas.2024.102785 · Cited by 4
Peacock, J., Provenzano, D. A., Fishman, M. A., Amirdelfan, K., Bromberg, T. A., Schmidt, T., White, T., Grewal, P. K., Justiz, R., Calodney, A. K., et al. (2024) · Pain Practice · doi:10.1111/papr.13407 · Cited by 4
Hand, L. K., Nelson, E., Glaser, A., Russell, J., Baber, G., Gratton, M. K. P., Barry, A., Bock, K. J., & Siengsukon, C. F. (2025) · Age and Ageing · doi:10.1093/ageing/afaf287 · Cited by 4
Carson, E., Dhillon, H. M., Vardy, J. L., Brown, C. S. B., Nunes-Zlotkowski, K. F., Della‐Fiorentina, S. A., Khan, S. N., Parsonson, A. O., Roncoloato, F., Pearson, A., et al. (2024) · Supportive Care in Cancer · doi:10.1007/s00520-024-08554-8 · Cited by 4
“…more has been recommended as the minimal clinically important difference for the PSQI; therefore an improvement in sleep quality in an individual is defined as a ≥ 3 point decrease in their PSQI total score from baseline to 9 weeks, and deterioration in sleep quality as a ≥ 3 point increase [20].”
BackgroundPark, N., Rouvere, J., Chase, E., Blanchard, B. E., Kaysen, D. L., Hendrickson, R. C., Fortney, J. C., & Cerimele, J. M. (2025) · Journal of Traumatic Stress · doi:10.1002/jts.23132 · Cited by 4
“The minimal important difference in previous literature ranges from 3.0 to 4.4 (Hughes et al., 2009; Longo et al., 2021).”
InfluentialKao, H. S. R., Wang, M., Yu, S., Yuan, S., Fung, M. M. Y., Zhu, L., Lam, S. P. W., Kao, T. T., & Kao, X. (2019) · Chinese Medicine and Culture · doi:10.4103/cmac.cmac_18_19 · Cited by 4
Subramanian, H., Trivedi, R., Fuchsova, V., Elder, E., Brand, A. H., Howle, J. R., Mann, G. J., DeFazio, A., Amis, T. C., & Kairaitis, K. (2023) · Sleep And Breathing · doi:10.1007/s11325-023-02946-6 · Cited by 4
“Clinically meaningful changes in sleep quality over the follow-up period were ascertained by score changes ≥ 3 au (ΔPSQI TOTAL score ≥ 3 au) [17].”
Changes over time in family members of adults with mild traumatic brain injury
Jones, K., Theadom, A., Prah, P., Starkey, N. J., Barker-Collo, S. L., Ameratunga, S. N., Feigin, V. L., & Study, F. T. B. (2019) · Brain Impairment · doi:10.1017/brimp.2019.27 · Cited by 4
“The MCID in a sample of patients with sleep disturbance is –3 (Hughes et al., 2009).”
BackgroundChung, K., Yeung, W., Leung, F. C.-Y., & Zhang, S. (2016) · European Journal of Integrative Medicine · doi:10.1016/j.eujim.2016.06.021 · Cited by 3
Zhao, F.-Y., Zhao, Y.-X., Yan, H., Hong, Y.-F., Ma, Q.-Y., Chen, S.-H., & Xu, H. (2019) · Journal of Acupuncture and Tuina Science · doi:10.1007/s11726-019-1092-0 · Cited by 3
Rapelli, G., Varallo, G., Scarpelli, S., Pietrabissa, G., Musetti, A., Plazzi, G., Franceschini, C., & Castelnuovo, G. (2023) · Frontiers in Psychology · doi:10.3389/fpsyg.2023.1144087 · Cited by 3
“Interestingly, the total PSQI decreased from the baseline in both follow-ups, meeting the minimal clinically important difference of ≥3 as suggested by previous evidence (Hughes et al., 2009; Eadie et al., 2013; McDonnell et al., 2014; Weinberg et al., 2020).”
BackgroundRahja, M., Laver, K., Mordaunt, D., Adnan, N., Vakulin, A., Lovato, N., & Crotty, M. (2023) · Archives of Rehabilitation Research and Clinical Translation · doi:10.1016/j.arrct.2023.100275 · Cited by 3
Treatment of Insomnia with Comorbid Mental Illness
Tracy, L. (2012) · InTech eBooks · doi:10.5772/32324 · Cited by 3
Metadata
- Authors
- Hughes, C. M., McCullough, C. A., Bradbury, I., Boyde, C., Hume, D., Yuan, J., Quinn, F., & McDonough, S. M.
- Affiliations
- University of Ulster (GB)
- Health and Rehabilitation Sciences Research Institute, University of Ulster, Ulster, UK
- British Association of Dermatologists (GB)
- Corresponding author
- Hughes, Ciara M
- Venue
- Acupuncture in Medicine
- Publisher
- SAGE Publications
- Published
- 2009-12
- Volume
- 27
- Issue
- 4
- Pages
- 163-168
- ISSN
- 0964-5284 (ISSN-L)
- 1759-9873
- OpenAlex
- W2146381169
- Cited by
- 136
- References
- 24
- Citations by year
- 2026: 3 · 2025: 16 · 2024: 8 · 2023: 24 · 2022: 18 · 2021: 16 · 2020: 10 · 2019: 9 · 2018: 6 · 2017: 2 · 2016: 7 · 2015: 5 · 2014: 4 · 2013: 4 · 2012: 2
- FWCI
- 3.23
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Acupuncture in Medicine (publishedVersion)
- PubMed (publishedVersion)
- HighWire Press Open Archive (submittedVersion)
- Topics
- Health Sciences › Medicine › Complementary and alternative medicine › Acupuncture Treatment Research Studies
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Sleep and related disorders
- Health Sciences › Medicine › Complementary and alternative medicine › Complementary and Alternative Medicine Studies
- Keywords
- acupuncture, reflexology, insomnia, primary insomnia, music therapy, sleep quality, patient recruitment and retention, feasibility, Pittsburgh Sleep Quality Index, SF-36v2, sleep diary
- MeSH terms
- Adult, Combined Modality Therapy, Feasibility Studies, Female, Humans, Sleep Initiation and Maintenance Disorders, Male, Massage, Middle Aged, Music Therapy, Surveys and Questionnaires, Sleep, Reproducibility of Results, Acupuncture Therapy, Treatment Outcome
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