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Completed

NCT Number: NCT01293695

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mind-Body Medicine Research Lab-Baylor University

Waco, Texas, 76798, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Postmenopausal as defined by:
  • no menstrual period in the past 12 months;
  • no menstrual period in the past 6 months and a medically documented history of FSH level greater than 40; or
  • 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

Treatment and study plan

hypnosis

Behavioral

Hypnosis relaxation in five weekly sessions

Other names: Hypnotic relaxation therapy, Hypnosis relaxation, Hypnotic intervention, Hypnosis intervention

Structured Attention

Other

Meets with therapist for five weekly sessions and receives structured attention/supportive counseling, but receives no hypnotic relaxation therapy

Other names: Placebo Comparator

Primary outcomes

  1. 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).

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Baylor University

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)
  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2007
Primary completion
2014
Study completion
2014
First posted
Feb 11, 2011
Registry last updated
Aug 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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