Hypnosis For Hot Flashes Among Postmenopausal Women in a Randomized Clinical Trial
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Hypnosis For Hot Flashes Among Postmenopausal Women in a Randomized Clinical Trial|
- Hot Flash Frequency [ Time Frame: 6 Weeks and 12 Weeks ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]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.
- Sternal Skin Conductance Monitor Used to Physiologically Measure Skin Moisture [ Time Frame: 6 Weeks and 12 Weeks ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
|Study Start Date:||September 2007|
|Study Completion Date:||March 2014|
|Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Hypnosis
Receives 5 weeks of hypnotic relaxation therapy
Hypnosis relaxation in five weekly sessions
Placebo Comparator: Structured Attention
Meets with therapist for five weekly sessions, but receives no hypnotic relaxation therapy
Other: Structured attention
Meets with therapist for five weekly sessions and receives structured attention/supportive counseling, but receives no hypnotic relaxation therapy
Other Name: Placebo Comparator
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 to a Structured-Attention Control.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01293695
|United States, Texas|
|Mind-Body Medicine Research Lab-Baylor University|
|Waco, Texas, United States, 76798|
|Principal Investigator:||Gary R Elkins, Ph.D.||Baylor University|