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| ID | Type | Description | Link |
|---|---|---|---|
| 5U01AT004634 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
| National Institutes of Health (NIH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypnosis | Active Comparator | Receives 5 weeks of hypnotic relaxation therapy |
|
| Structured Attention | Placebo Comparator | Meets with therapist for five weekly sessions, but receives no hypnotic relaxation therapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypnosis | Behavioral | Hypnosis relaxation in five weekly sessions |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Postmenopausal as defined by:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Gary R Elkins, Ph.D. | Baylor University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mind-Body Medicine Research Lab-Baylor University | Waco | Texas | 76798 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34403019 | Derived | 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. | |
| 21989181 | Derived | 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. |
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Recruitment occurred from December, 2008 to April, 2012. Participants were recruited by using fliers, mailings, billboard advertising and word-of-mouth. Local clinics were also visited and informative materials were left with physicians.
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| ID | Title | Description |
|---|---|---|
| FG000 | Hypnosis | Receives 5 weeks of hypnotic relaxation therapy Hypnosis: Hypnosis relaxation in five weekly sessions |
| FG001 | Structured Attention | Meets with therapist for five weekly sessions, but receives no hypnotic relaxation therapy Structured Attention: Meets for five weekly sessions for discussion on hot flashes; no hypnosis |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Hypnosis | Receives 5 weeks of hypnotic relaxation therapy (HRT) Hypnosis: Hypnosis relaxation in five weekly sessions |
| BG001 | Structured Attention | Meets with therapist for five weekly sessions, but receives no hypnotic relaxation therapy Structured Attention: Meets for five weekly sessions for discussion on hot flashes; no hypnosis |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Mean | Standard Deviation | hot flashes per week | 6 Weeks and 12 Weeks |
|
Adverse event data were collected for 12 weeks. (i.e.: weekly from baseline to 12 week follow-up)
Adverse events were assessed at each session by participant self-report.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hypnosis | Receives 5 weeks of hypnotic relaxation therapy Hypnosis: Hypnosis relaxation in five weekly sessions |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin irritation | Skin and subcutaneous tissue disorders | Systematic Assessment | mild skin irritation from the skin conductance monitor electrode adhesive, requiring no medical intervention to resolve. |
limitations: results may not generalize to all women with hot flashes
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gary Elkins, Director of the Mind-Body Medicine Research Laboratory | Baylor University | 254-296-0643 | gary_elkins@baylor.edu |
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| ID | Term |
|---|---|
| D019584 | Hot Flashes |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D006990 | Hypnosis |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D011613 | Psychotherapy |
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| Structured attention | Other | Meets with therapist for five weekly sessions and receives structured attention/supportive counseling, but receives no hypnotic relaxation therapy |
|
|
| 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| Marital Status | Number | participants |
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| Education | Number | participants |
|
| Hot Flash Frequency | Hot flash frequency and hot flash severity were obtained using the Hot Flash Symptoms Diary. Participants recorded their hot flashes over seven days marking each hot flash (frequency) and rating the severity of each as mild (1), moderate (2), severe (3), and very severe (4). | Mean | Standard Deviation | hot flashes per week |
|
| 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. | Mean | Standard Deviation | units on a scale |
|
| Biolog Hot Flash Monitor (physiological measure) | 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. | Mean | Standard Deviation | micro Siemens |
|
| Hot Flash Related Daily Interference Scale (HFRDIS) | This questionnaire was 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. | Mean | Standard Deviation | units on a scale |
|
| Pittsburg Sleep Quality Index (PSQI) | The Pittsburg Sleep Quality Index (PSQI) is a self-report inventory designed to measure sleep quality. The participants self rated 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 was 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. | Mean | Standard Deviation | units on a scale |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 6 Weeks and 12 Weeks |
|
|
|
| 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. | Analysis was conducted on all available physiological data to determine hot flash frequency. Data was missing for 29 participants in the hypnosis group and 17 participants in the structured attention group. | Posted | Mean | Standard Deviation | Micro Siemens | 6 Weeks and 12 Weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 6 Weeks and 12 Weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 6 Weeks and 12 Weeks |
|
|
|
| 0 |
| 93 |
| 13 |
| 93 |
| EG001 | Structured Attention | Meets with therapist for five weekly sessions, but receives no hypnotic relaxation therapy Structured Attention: Meets for five weekly sessions for discussion on hot flashes; no hypnosis | 0 | 94 | 12 | 94 |
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| D004191 |
| Behavioral Disciplines and Activities |