A Mind-Body Intervention for Hot Flash Management

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
Baylor University
Study ID
NCT03572153
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Self-Administered Hypnosis — BEHAVIORAL
    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.
  • Self-Administered White Noise Hypnosis — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Mar 4, 2019
Status verified
May 2025
Primary completion
Feb 16, 2024
Completion
Feb 16, 2024

Study Design

Enrollment
250 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Self-Administered Hypnosis
    Self-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.
  • Active Comparator: Self-Administered White Noise Hypnosis
    Self-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.

Primary Outcome Measure

Hot Flash Daily Diary [ Time Frame: The hot flash daily diary was collected at baseline (week 0), endpoint (week 6) and follow-up (week 12). ]

Locations (2)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109-
Baylor UniversityWacoTexas76798-

Find similar trials in Ann Arbor, MI

By condition
Breast cancerMenopause
By specialty
OncologyBreast oncologyWomen's healthFertility
By research site
University of Michigan· Ann Arbor, MIBaylor University· Waco, TX

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