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| Name | Class |
|---|---|
| TriHealth Medical Education Research Fund | UNKNOWN |
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Female Sexual Dysfunction (FSD) affects up to 43% of women in the United States and Hypoactive Sexual Desire Disorder (HSDD) is the most common form. There is no standardized treatment for this condition. We know that alternative therapies such as acupuncture have been beneficial to women suffering from urinary incontinence, chronic lower back pain, and migraines. We hypothesize that the quality of life for premenopausal women with hypoactive sexual desire disorder (HSDD) will improve with initiation of acupuncture therapy for a duration of 5-weeks. Validated questionnaires are administered at the time of enrollment and 1 week after the final acupuncture session as the method of analyzing our primary outcome.
Each woman will receive experimental therapy with acupuncture twice a week for five weeks and complete a packet of validated questionnaires/surveys at the 1st visit in person and at week 6 by mail.
The acupuncture sessions include:
Subsequent Sessions (9 more) with the certified acupuncturist
The questionnaires/surveys include questions about:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture | Experimental | Acupuncture Therapy - twice weekly sessions for 5 weeks: 1st session 60 minutes with remaining 9 session approximately 45 minutes each. Physical exam at 1st session includes evaluation of peripheral pulses, head, neck, throat/tongue. No pelvic exam required. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Procedure | Acupuncture Therapy - Initial Evaluation History including: chief complaint, diet, level of diaphoresis, water intake, digestive function, menstrual cycling, sleep habits, overall mood. Physical Exam: inspection of tongue and palpation of central and peripheral pulses. Chinese Diagnoses for Female Sexual Dysfunction: Kidney Yang Deficiency; Liver Qi Stagnation; Generalized Blood Deficiency; Spleen Yang Deficiency; Heart Fire - Subsequent Sessions 25 minute sessions, twice weekly, for 5 weeks = total 10 sessions Needle usage = 8-20, average 14 per session Typically placed on the scalp, lower abdomen, elbows and knees |
| Measure | Description | Time Frame |
|---|---|---|
| Female Sexual Function Index (FSFI) | Determined by a change in the desire domain of the Female Sexual Function Index (FSFI) from baseline at enrollment to study completion at 6 weeks after initiation of intervention. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Female Sexual Distress Scale (FSDS-R) | Determined by functional data points distributed at enrollment and 6 weeks: Female Sexual Distress scale - revised (FSDS-R) | 6 weeks |
| Short Form-12 (SF-12) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TriHealth | Cincinnati | Ohio | 45220 | United States |
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| ID | Term |
|---|---|
| D020018 | Sexual Dysfunctions, Psychological |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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Determined by functional data points distributed at enrollment and 6 weeks:
Short Form-12 (SF-12)
| 6 weeks |
| Generalized Anxiety-Disorder-7 (GAD-7) and Prime Health Questionnaire-9 (PHQ-9) | Determined by functional data points distributed at enrollment and 6 weeks: Generalized Anxiety-Disorder-7 (GAD-7) and Prime Health Questionnaire-9 (PHQ-9) | 6 weeks |
| World Health Organization Quality of Life- BREF (WHOQOL) | Determined by functional data points distributed at enrollment and 6 weeks: World Health Organization Quality of Life- BREF (WHOQOL) | 6 weeks |
| Patient Global Impression of Improvement (PGI-I) | Determined by functional data points distributed at enrollment and 6 weeks: Patient Global Impression of Improvement (PGI-I) | 6 weeks |