Clinical trial NCT01293695: Hypnosis For Hot Flashes Among Postmenopausal Women in a Randomized Clinical Trial
Official title: Hypnosis For Hot Flashes Among Postmenopausal Women in a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hot Flashes
Keywords: hot flashes
post menopausal women
skin conductance monitors
hypnosis
hypnotizability
Lead sponsor: Baylor University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
name: National Institutes of Health (NIH)
First posted: 2011-02-11
Enrollment: 187
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Hot Flash Frequency
timeFrame: 6 Weeks and 12 Weeks
measure: Hot Flash Score
timeFrame: 6 Weeks and 12 Weeks
measure: Hot Flash Related Daily Interference Scale (HFRDIS)
timeFrame: 6 Weeks and 12 Weeks
Secondary outcomes:
measure: Sternal Skin Conductance Monitor Used to Physiologically Measure Skin Moisture
timeFrame: 6 Weeks and 12 Weeks
measure: Pittsburg Sleep Quality Index (PSQI)
timeFrame: 6 Weeks and 12 Weeks
Other outcomes:
Locations:
city: Waco
country: United States
facility: Mind-Body Medicine Research Lab-Baylor University
state: Texas
Study officials:
affiliation: Baylor University
name: Gary R Elkins, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roberts RL, Rhodes JR, Elkins GR. Effect of Hypnosis on Anxiety: Results from a Randomized Controlled Trial with Women in Postmenopause. J Clin Psychol Med Settings. 2021 Dec;28(4):868-881. doi: 10.1007/s10880-021-09810-3. Epub 2021 Aug 17.
citation: Elkins GR, Fisher WI, Johnson AK. Hypnosis for hot flashes among postmenopausal women study: a study protocol of an ongoing randomized clinical trial. BMC Complement Altern Med. 2011 Oct 11;11:92. doi: 10.1186/1472-6882-11-92.