N/A N=250 Randomized Double-blind Supportive Care

A Mind-Body Intervention for Hot Flash Management

Hot Flashes · Postmenopausal Symptoms · Breast Cancer

Bottom Line

View on ClinicalTrials.gov: NCT03572153 ↗

Enrolled (actual)

250

Serious AEs

0.0%

Results posted

Jun 2025

Primary outcome: Primary: Hot Flash Daily Diary — 88.7; 94.6; 41.3; 55.9 Hot Flash Score

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Self-Administered Hypnosis (Behavioral); Self-Administered White Noise Hypnosis (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Baylor University
Primary completion: Feb 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Hot Flash Daily Diary	88.7; 94.6; 41.3; 55.9; 34.7; 52.8	—
SECONDARY Hot Flash Related Daily Interference Scale	49.3; 47.3; 25; 29.6; 21.4; 24.2	—
SECONDARY Emotional Distress Anxiety Scale	49.83; 50.82; 45.93; 47.59; 44.85; 47.79	—
SECONDARY Pittsburgh Sleep Quality Index	7.08; 7.13; 6.23; 6.31; 6.33; 6.10	—
SECONDARY Subject Global Impression of Change	1.92; 1.20	—
SECONDARY Perceived Stress Scale	12.38; 12.11; 11.36; 11.16; 10.26; 10.64	—

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.

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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
Currently using any Complementary and Alternative Medicine (CAM) treatments for vasomotor symptoms. (This would include soy products and other phytoestrogens, black cohosh, and any mind-body techniques including meditation, yoga, etc.). If any therapies are used for reasons other than hot flashes and hot flash frequency meets inclusion criteria, then woman is eligible)
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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03572153). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.