Program to Overcome Pelvic Pain With Yoga (POPPY)
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|ClinicalTrials.gov Identifier: NCT02261740|
Recruitment Status : Completed
First Posted : October 10, 2014
Last Update Posted : October 4, 2016
The POPPY Study is a pilot of an Iyengar-based, therapeutic yoga program, used to treat pelvic or genital pain, in up to 16 women. Women aged 21 years and older who report persistent or recurrent pelvic or genital pain for at least 6 months that interferes with sexual activity will be recruited from the San Francisco Bay Area. Those who meet eligibility criteria will take part in a 6-week yoga therapy program designed by an expert yoga panel. Women will attend twice-weekly group classes focusing on Iyengar-based yoga techniques that have been carefully selected for their potential to improve women's genito-pelvic pain and practice yoga at home one additional hour a week.
The investigators will evaluate changes in the severity and impact of women's pain using validated questionnaires and diaries.
|Condition or disease||Intervention/treatment||Phase|
|Pelvic Pain||Behavioral: Yoga Therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Program to Overcome Pelvic Pain With Yoga (POPPY) (a.k.a., Development of a Therapeutic Yoga Program for Female Genito-Pelvic Pain)|
|Study Start Date :||October 2014|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||June 2016|
Experimental: Yoga Therapy Group
Participants will attend twice-weekly group yoga classes and be instructed to practice yoga at home one additional hour a week, using a written manual.
Behavioral: Yoga Therapy
A 90-minute orientation session led by the yoga class instructors, followed by 90-minute group yoga classes twice weekly for 6 weeks. Classes will be led by an experienced instructor. Women will also be taught to avoid any habits that may worsen their genito-pelvic pain (e.g., straining their pelvic floor muscles).
Participants will also be asked to practice yoga at home an additional hour per week throughout the 6-week yoga therapy program. Participants will be given a detailed written manual to use for home practice.
- Change from baseline in severity of pelvic pain after yoga therapy program. [ Time Frame: Baseline to 6-Weeks ]Self-reported daily pain severity, as rated by Daily Pain Log (scale from 0-10).
- Change in baseline sexual functioning after yoga therapy program. [ Time Frame: Baseline, 6-Weeks ]We will use standard questionnaires to assess changes in sexual function.
- Change in baseline quality of life after yoga therapy program. [ Time Frame: Baseline, 6-Weeks ]We will use standard questionnaires to assess changes in overall quality of life.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02261740
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94115|
|Principal Investigator:||Alison Huang, MD, MAS||University of California, San Francisco|