A Mind-Body Intervention for Hot Flash Management
Self-Administered Hypnosis Treatment for the Management of Hot Flashes in Women: A Randomized Clinical Trial
4 other identifiers
interventional
250
1 country
2
Brief Summary
The long-term goal of this program of research is to determine safe and effective non-hormonal interventions for menopausal symptoms. The main goal of this study is to evaluate whether self-administered hypnosis can be used to significantly reduce hot flashes more than self-administered white noise hypnosis over 6 weeks of home practice. The investigators are also examining the impact of each hypnosis group on sleep, anxiety, perceived and measured stress, heart rate variability, and daily activities.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2019
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 17, 2018
CompletedFirst Posted
Study publicly available on registry
June 28, 2018
CompletedStudy Start
First participant enrolled
March 4, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 16, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 16, 2024
CompletedResults Posted
Study results publicly available
June 5, 2025
CompletedJune 5, 2025
May 1, 2025
5 years
June 17, 2018
March 27, 2025
May 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hot Flash Daily Diary
Participants completed the Hot Flash Daily Diary (Sloan et al., 2001) every day for 6 weeks to measure the daily frequency and severity (mild, moderate, severe, and very severe) of hot flashes. A total hot flash score was calculated for each participant (product of frequency x severity) after severity ratings were assigned a point value as follows: * mild = 1 * moderate = 2 * severe = 3 * very severe = 4 The hot flash score was then calculated by multiplying the participants' frequency and severity ratings of hot flashes, divided by the total number of days. A lower score indicates less frequent and/or severe hot flashes.
The hot flash daily diary was collected at baseline (week 0), endpoint (week 6) and follow-up (week 12).
Secondary Outcomes (5)
Hot Flash Related Daily Interference Scale
The Hot Flash Related Daily Interference Scale was completed at Baseline (week 0), at endpoint (week 6) and at follow-up (week 12).
Emotional Distress Anxiety Scale
Baseline, 6 & 12 Weeks
Pittsburgh Sleep Quality Index
Baseline, 6, & 12 weeks.
Subject Global Impression of Change
The Subject Global Impressions of Change will be completed only at 6 weeks.
Perceived Stress Scale
Baseline, 6, & 12 weeks
Other Outcomes (1)
Self-Hypnosis Practice Log
The practice log was completed daily by the participants and submitted to the interventionists at the end of each week throughout the study's duration (weeks one through six) and at follow-up (week 12)."
Study Arms (2)
Self-Administered Hypnosis
EXPERIMENTALSelf-administered hypnosis will be practiced daily using different audio recordings using the researcher's voice. Participants will practice hypnosis at home after completing the two study sessions.
Self-Administered White Noise Hypnosis
ACTIVE COMPARATORSelf-administered white noise hypnosis will be practiced daily using a white noise recording. Participants will practice hypnosis at home after completing the two consent and education sessions.
Interventions
Participants will be listening to six 20-minute hypnosis audio recordings with hypnotic induction. Participants will be encouraged to practice daily, and each recording will build on the content of the previous recordings. They will also be provided with booklets of information about hot flashes, including treatment options.
Participants will be listening to the same 20-minute white noise audio recordings for 6 weeks and will be encouraged to practice daily.They will also be provided with booklets as well as an audio recording with information about hot flashes including treatment options.
Eligibility Criteria
You may qualify if:
- Postmenopausal as defined by one of the following criteria:
- No menstrual period in the past 12 months
- Chemical menopause (LHRH antagonists)
- Surgical Menopause (bilateral oophorectomy)
- Evidence of menopause status per FSH and estradiol levels per institutional guidelines. Self-reported history of a minimum of 4 hot flashes per day or 28 hot flashes per week at baseline.
- Age over 18 years and able to give consent for participation in the study.
- Have discontinued other putative therapies for hot flashes for at least one month prior to enrollment (Vitamin E will be allowed)
- Women with a diagnosis of DCIS or invasive breast cancer stages 0-III are allowed to participate and may be on endocrine therapy of any kind. If on endocrine therapy, women must be on it for 4 weeks and not expected to stop it during the study. If not on endocrine therapy, participants should not be planning to start during the course of the study. However, unexpected treatment will not require study withdrawal but will be recorded and considered in the analysis.
You may not qualify if:
- Currently receiving other simultaneous treatment for hot flashes (antidepressant use is allowed if being used for mood alterations and participant has been on the antidepressant for at least 3 months with no plans to change dose or antidepressant during this study)
- Diagnosis of clinical depression or acute anxiety disorder
- Diagnosis of a serious psychological illness, specifically psychoses, schizophrenia or borderline personality disorder
- Currently using hypnosis for any reason
- PHQ-4 score ≥ 9
- Non-English speaking
- Women with stage IV breast cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Baylor Universitylead
- National Center for Complementary and Integrative Health (NCCIH)collaborator
- University of Michigancollaborator
Study Sites (2)
University of Michigan
Ann Arbor, Michigan, 48109, United States
Baylor University
Waco, Texas, 76798, United States
Related Publications (1)
Elkins G, Arring N, Morgan G, Lorenz T, Muniz V, Lafferty C, Scheffrahn K, Alldredge C, Barton D. Self-Administered Hypnosis vs Sham Hypnosis for Hot Flashes: A Randomized Clinical Trial. JAMA Netw Open. 2025 Nov 3;8(11):e2542537. doi: 10.1001/jamanetworkopen.2025.42537.
PMID: 41217756DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gary Elkins, PhD
- Organization
- Baylor University
Study Officials
- PRINCIPAL INVESTIGATOR
Gary Elkins, Ph.D.
Baylor University
- PRINCIPAL INVESTIGATOR
Debra Barton, RN,PhD,FAAN
University of Michigan
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Mind-Body Medicine Research Lab
Study Record Dates
First Submitted
June 17, 2018
First Posted
June 28, 2018
Study Start
March 4, 2019
Primary Completion
February 16, 2024
Study Completion
February 16, 2024
Last Updated
June 5, 2025
Results First Posted
June 5, 2025
Record last verified: 2025-05