Hot Flashes Clinical Trial
Official title:
Hypnosis For Hot Flashes Among Postmenopausal Women in a Randomized Clinical Trial
Verified date | September 2015 |
Source | Baylor University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 187 |
Est. completion date | March 2014 |
Est. primary completion date | March 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Mind-Body Medicine Research Lab-Baylor University | Waco | Texas |
Lead Sponsor | Collaborator |
---|---|
Baylor University | National Center for Complementary and Integrative Health (NCCIH), National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hot Flash Frequency | 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). | 6 Weeks and 12 Weeks | No |
Primary | Hot Flash Score | 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. |
6 Weeks and 12 Weeks | No |
Primary | Hot Flash Related Daily Interference Scale (HFRDIS) | 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. | 6 Weeks and 12 Weeks | No |
Secondary | Sternal Skin Conductance Monitor Used to Physiologically Measure Skin Moisture | 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. | 6 Weeks and 12 Weeks | No |
Secondary | Pittsburg Sleep Quality Index (PSQI) | 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. | 6 Weeks and 12 Weeks | No |
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