Effects of a Hypnosis Session Before General Anesthesia on Postoperative Outcomes in Patients Who Underwent Minor Breast Cancer Surgery: The HYPNOSEIN Randomized Clinical Trial
Open accessAbstract
Importance: Hypnosis is now widespread in medical practice and is emerging as an alternative technique for pain management and anxiety. However, its effects on postoperative outcomes remain unclear. Objective: To evaluate the efficacy of a preoperative hypnosis session for reducing postoperative breast pain in patients who underwent minor breast cancer surgery. Design, Setting, and Participants: The HYPNOSEIN prospective randomized clinical trial was conducted from October 7, 2014, to April 5, 2016. In this multicenter study in France, 150 women scheduled for minor breast cancer surgery were randomized between control and hypnosis arms, and 148 (71 control and 77 hypnosis) were included in the intent-to-treat analysis. Intervention: On the day of surgery, eligible patients were randomly assigned (1:1) to the control arm or the hypnosis arm. Patients (but not the care teams) were blinded to the arm to which they were assigned. A 15-minute hypnosis session before general anesthesia in the operating room was performed in the hypnosis arm. Main Outcomes and Measures: The primary end point was breast pain reduction (by 2 on a visual analog scale), assessed immediately before discharge from the postanesthesia care unit (PACU). Secondary end points were nausea/vomiting, fatigue, comfort/well-being, anxiety, and PACU length of stay, assessed at different times until postoperative day 30. Results: The median patient age was 57 years (range, 33-79 years) in the control arm and 53 years (range, 20-84 years) in the hypnosis arm. Baseline characteristics were similar in the 2 arms. The median duration of the hypnosis session was 6 minutes (range, 2-15 minutes). The use of intraoperative opioids and hypnotics was lower in the hypnosis arm. The mean (SD) breast pain score (range, 0-10) was 1.75 (1.59) in the control arm vs 2.63 (1.62) in the hypnosis arm (P = .004). At PACU discharge and with longer follow-up, no statistically significant difference in breast pain was reported. Fatigue was significantly lower in the hypnosis arm on the evening of surgery (mean [SD] score, 3.81 [2.15] in the control arm vs 2.99 [2.56] in the hypnosis arm; P = .03). The median PACU length of stay was 60 minutes (range, 20-290 minutes) in the control arm vs 46 minutes (range, 5-100 minutes) in the hypnosis arm (P = .002). Exploratory analyses according to patient perception of whether she received hypnosis showed significantly lower fatigue scores in the perceived hypnosis subgroup on the evening of surgery (mean [SD], 4.13 [2.26] for no perceived hypnosis vs 2.97 [2.42] for perceived hypnosis; P = .01). Anxiety was also significantly lower on the evening of surgery in the perceived hypnosis subgroup (mean [SD], 0.75 [1.64] for perceived hypnosis vs 1.67 [2.29] for no perceived hypnosis; P = .03). Conclusions and Relevance: The results of this study do not support a benefit of hypnosis on postoperative breast pain in women undergoing minor breast cancer surgery. However, other outcomes seem to be improved, which needs to be confirmed by further studies. Trial Registration: EudraCT Identifier: 2014-A00681-46 and ClinicalTrials.gov Identifier: NCT03253159.
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A French study following a similar protocol but with some deviations was not able to reproduce the effects.
“However, a French study, following a similar protocol but with some deviations from the American study, was not able to reproduce the effects [41].”
From Pre- and post-operative psychological interventions to prevent pain and fatigue after breast cancer surgery (PREVENT): Protocol for a randomized controlled trial (2022) · cites this paper as [41]
The Methods identify this as a French trial, and the Discussion compares it with Montgomery et al.’s breast-surgery hypnosis trial, noting a difference in blinding. The French trial did not reproduce the earlier reduction in postoperative pain, but the Results report lower evening-of-surgery fatigue and greater patient satisfaction in its hypnosis arm. Thus, saying it could not reproduce “the effects” without qualification is too broad. (LLM, conf=0.87)
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- Authors
- Amraoui, J., Pouliquen, C., Fraisse, J., Dubourdieu, J., Rey Dit Guzer, S., Leclerc, G., de Forges, H., Jarlier, M., Gutowski, M., Bleuse, J.-P., Janiszewski, C., Diaz, J., & Cuvillon, P.
- Affiliations
- Université de Montpellier (FR)
- Institut Paoli-Calmettes (FR)
- Department of Anesthesia, Montpellier Cancer Institute (ICM), University of Montpellier, Montpellier, France
- Department of Clinical Research, Montpellier Cancer Institute (ICM), University of Montpellier, Montpellier, France
- Corresponding author
- Amraoui, Jibba
- ORCID
- Venue
- JAMA Network Open
- Publisher
- American Medical Association (AMA)
- Published
- 2018-08-17
- Volume
- 1
- Issue
- 4
- Pages
- e181164
- ISSN
- 2574-3805 (ISSN-L)
- PMC
- PMC6324272
- OpenAlex
- W2888625541
- Cited by
- 60
- References
- 25
- Citations by year
- 2026: 5 · 2025: 12 · 2024: 10 · 2023: 6 · 2022: 9 · 2021: 8 · 2020: 4 · 2019: 4 · 2018: 1 · 2016: 1
- FWCI
- 2.53
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- cc-by
- Locations
- JAMA Network Open (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- HAL (submittedVersion, cc-by)
- Topics
- Life Sciences › Neuroscience › Cognitive Neuroscience › Pain Management and Placebo Effect
- Health Sciences › Medicine › Surgery › Anesthesia and Pain Management
- Health Sciences › Dentistry › Oral Surgery › Dental Anxiety and Anesthesia Techniques
- Keywords
- preoperative hypnosis, breast cancer surgery, breast pain, postoperative pain, general anesthesia, post-anesthesia care unit, fatigue, nausea and vomiting, anxiety, postoperative outcomes, intraoperative opioid use, patient well-being, placebo-controlled intervention, patient-reported outcomes, postoperative hospital stay
- MeSH terms
- Adult, Aged, Aged, 80 and over, Anesthesia, General, Breast Neoplasms, Female, Humans, Hypnosis, Middle Aged, Postoperative Pain, Preoperative Care, Prospective Studies, Minor Surgical Procedures, Single-Blind Method, Young Adult
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