Clinical Trial: Hypnosis For Hot Flashes Among Postmenopausal Women in a Randomized Clinical Trial

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Hypnosis For Hot Flashes Among Postmenopausal Women in a Randomized Clinical Trial

Brief Summary: This study is designed to determine the effect of a Hypnosis Intervention on reducing hot flash frequency (perceived impact vs. physiologically measured impact), severity and daily interference in post-menopausal women. It is felt that the Hypnosis Intervention will result in significantly lower hot flash frequency, severity and daily interference scores (perceived impact vs. physiologically measured impact) versus Structured-Attention Control.

Detailed Summary:

The aging population of the United States and findings from the Women's Health Initiative that indicate a shift in the risk/benefits balance of hormone therapy have created a growing interest in alternative treatments for hot flashes. Hot flashes are among the most severe and frequent symptoms experienced by women during menopause. Over 66% of post-menopausal women experience hot flashes. As a result, there is a pressing need for safe and effective treatments for hot flashes. Hypnosis is one mind-body therapy that seems particularly promising for treating hot flashes.

However, the treatment effectiveness of hypnosis in reducing physiologically measured (i.e. physiologically measured impact) hot flashes with post-menopausal women has yet to be established relative to a Structured-Attention Control. This is a critical step to further investigate the intervention and to determine if hypnosis reduces the symptoms (i.e. the number of physiological hot flashes) or only the women's perception of symptoms.

Also, the physiologic mechanism by which hypnosis may operate in reducing hot flashes is not known. The present study will compare hypnosis to a Structured-Attention Control in reducing hot flashes (perceived and physiologically monitored) in post-menopausal women in a randomized clinical trial.

Innovations of this study are that it will be the first full scale test of hypnosis for hot flashes; one of the first studies to examine both perceived impact and physiologically measured impact of a mind-body intervention for hot flashes using state-of-the-art 24 hour ambulatory physiological monitoring; the first study to examine the effect of hypnosis for hot flashes on cortisol; and the first investigation of the role of cognitive expectancies in treatment of hot flashes in comparison
Sponsor: Baylor University

Current Primary Outcome:

  • Hot Flash Frequency [ Time Frame: 6 Weeks and 12 Weeks ]
    The Hot Flash Symptoms Diary was used to measure hot flash frequency. Participants recorded their hot flashes over seven days by daily frequency and severity. This instrument provides a measure of hot flash frequency and hot flash score (product of frequency x severity).
  • Hot Flash Score [ Time Frame: 6 Weeks and 12 Weeks ]

    Hot Flash Score is a product of frequency of hot flashes × severity of hot flashes, which could range from 0 (best possible outcome) to infinity (worst possible outcome).

    Hot flash frequency and hot flash severity were obtained using the Hot Flash Symptoms Diary. Participants recorded their daily hot flashes marking each hot flash (frequency) and rating the severity of each as mild (1), moderate (2), severe (3), and very severe (4).

    The values presented represent the average of daily hot flash scores.

  • Hot Flash Related Daily Interference Scale (HFRDIS) [ Time Frame: 6 Weeks and 12 Weeks ]
    This questionnaire is used to measure the effects of hot flashes on women as they go about their daily activities. Answers on the scale can range 0 (Do Not Interfere) to 10 (Completely Interfere). The total score was computed by averaging the subjective ratings over the 10 items. A lower score indicates better outcome.


Original Primary Outcome: Number and severity ratings of daily hot flashes [ Time Frame: Weeks 1-6 and Week 11 ]

Participants will record the number of hot flashes they experience each day. In addition, they will rate the severity of each hot flash on a 1-4 scale ranging from mild, moderate, severe, to very severe.


Current Secondary Outcome:

  • Sternal Skin Conductance Monitor Used to Physiologically Measure Skin Moisture [ Time Frame: 6 Weeks and 12 Weeks ]
    As a secondary outcome, hot flashes were measured using a Biolog ambulatory recorder. Skin conductance was expressed in micro Siemens (0 to infinity) and the final value was obtained by averaging the recorded skin conductance for a period of 24 hours. Lower skin conductance measure indicates less sweating.
  • Pittsburg Sleep Quality Index (PSQI) [ Time Frame: 6 Weeks and 12 Weeks ]
    The Pittsburg Sleep Quality Index (PSQI) is a self-report inventory designed to measure sleep quality. The participants self rate their sleep quality over seven areas of sleep.The questions about sleep quality are answered on a 0-3 scale with higher scores indicating greater sleep pathology. The global score is determined by summing the raw scores of the seven sleep components. The global score can range from 0 - 21 and total scores above 5 are normally considered indicative of poor sleep quality.


Original Secondary Outcome: Hot flashes as indicated by changes in skin conductance measured by a device that is worn by the participant for 24 hours at a time. [ Time Frame: Weeks1, 6, and 11 ]

As a secondary outcome, hot flashes will be measured using a Biolog. This is a state-of-the-art device that measures changes in skin conductance due to sweating associated with hot flashes. The Biolog will be worn for 24 hours at a time to provide an objective measure of hot flashes during the day and night.


Information By: Baylor University

Dates:
Date Received: February 10, 2011
Date Started: September 2007
Date Completion:
Last Updated: July 18, 2016
Last Verified: July 2016