Hot Flashes Clinical Trial
Official title:
Hypnosis For Hot Flashes Among Postmenopausal Women in a Randomized Clinical Trial
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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