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

Baylor University

Status

Completed

Conditions

Hot Flashes

Treatments

Behavioral: Hypnosis

Other: Structured attention

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01293695

5U01AT004634 (U.S. NIH Grant/Contract)

194610

Details and patient eligibility

About

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.

Full description

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.

Enrollment

187 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Postmenopausal as defined by:
1. no menstrual period in the past 12 months;
2. no menstrual period in the past 6 months and a medically documented history of FSH level greater than 40; or
3. women who have had a bilateral oophorectomy.
A self-reported history of a minimum of 7 hot flashes per day or 50 hot flashes per week at baseline.
Age over 18 years and ability to give her own consent for participation in the study.
Have discontinued other putative therapies for hot flashes for at least one month prior to enrollment
Ability to attend weekly sessions.

Exclusion criteria

Receiving other simultaneous treatment for hot flashes.
Using any CAM (Complementary and Alternative Medicine) treatments for vasomotor symptoms • Any medical or psychiatric condition that in the opinion of the investigator puts the participant at potential risk during the study.
Currently using hypnosis for any reason.
Inability to speak or understand English