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

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ClinicalTrials.gov Identifier: NCT01293695
Recruitment Status : Completed
First Posted : February 11, 2011
Results First Posted : September 17, 2015
Last Update Posted : August 16, 2016
Sponsor:
Collaborators:
National Center for Complementary and Integrative Health (NCCIH)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Gary R. Elkins, Baylor University

February 10, 2011
February 11, 2011
January 28, 2015
September 17, 2015
August 16, 2016
September 2007
March 2014   (Final data collection date for primary outcome measure)
  • 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.
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.
Complete list of historical versions of study NCT01293695 on ClinicalTrials.gov Archive Site
  • 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.
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.
Not Provided
Not Provided
 
Hypnosis For Hot Flashes Among Postmenopausal Women in a Randomized Clinical Trial
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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Hot Flashes
  • Behavioral: Hypnosis
    Hypnosis relaxation in five weekly sessions
    Other Names:
    • Hypnotic relaxation therapy
    • Hypnosis relaxation
    • Hypnotic intervention
    • Hypnosis intervention
  • 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
  • Active Comparator: Hypnosis
    Receives 5 weeks of hypnotic relaxation therapy
    Intervention: Behavioral: Hypnosis
  • Placebo Comparator: Structured Attention
    Meets with therapist for five weekly sessions, but receives no hypnotic relaxation therapy
    Intervention: Other: Structured attention
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
187
180
March 2014
March 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01293695
194610
5U01AT004634 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Plan to Share IPD: No
Gary R. Elkins, Baylor University
Baylor University
  • National Center for Complementary and Integrative Health (NCCIH)
  • National Institutes of Health (NIH)
Principal Investigator: Gary R Elkins, Ph.D. Baylor University
Baylor University
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP