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A Mind-Body Intervention for Hot Flash Management

NCT03572153 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2025-06-05

Study results available
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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.

Conditions

Interventions

BEHAVIORAL

Self-Administered Hypnosis

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.

BEHAVIORAL

Self-Administered White Noise Hypnosis

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.

Sponsors & Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

    collaborator NIH

  • University of Michigan

    collaborator OTHER

  • Baylor University

    lead OTHER

Principal Investigators

  • Gary Elkins, Ph.D. · Baylor University

  • Debra Barton, RN,PhD,FAAN · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-04
Primary Completion
2024-02-16
Completion
2024-02-16

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03572153 on ClinicalTrials.gov