Motivational Interviewing in Women's Pelvic Wellness Education
NCT02758561
ABOUT THIS STUDY
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Adult Trials: 18+ Years
- Women ages >18 years old
- Urinary incontinence and/or pelvic organ prolapse
- First visit with urogynecologist
- Anal incontinence
- Previous pelvic radiation therapy
- Requirement for a Substitute Decision Maker
- Inability to attend the workshop
- Unwilling to attend an English-language workshop
- Unwilling to complete English-language surveys
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- Ottawa, Ontario
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Motivational Interviewing in Women's Pelvic Wellness Education | |||
| Official Title ICMJE | 2015 Motivational Interviewing in Women's Pelvic Wellness Education Project | |||
| Brief Summary | This pilot study will assess the feasibility and acceptability of an educational workshop on pelvic floor disorders and its potential impact on decisional conflict. | |||
| Detailed Description | Pelvic floor disorders can significantly affect a woman's quality of life, yet many feel uncomfortable openly discussing these topics. Treatments include lifestyle modification, medications, and/or surgery. "Decisional conflict" arises when patients have difficulty choosing between several viable treatment options. Factors contributing to decisional conflict include biased information, poor peer support, and unaddressed fears. Effective counselling may help address these factors. There are few studies on how decision coaching can help women with prolapse and incontinence reach a satisfactory decision about treatment. This study aims to use the principals of shared decision making to address decisional conflict surrounding treatment for pelvic floor disorders. Specifically, the investigators will evaluate the feasibility and acceptability of small group workshops on pelvic organ prolapse and urinary incontinence led by a nurse continence advisor and a psychologist (decision coach). Results of this study will inform future development of interdisciplinary, patient-centered approaches to enhanced decision making in women's health. | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Not Applicable | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Treatment | |||
| Condition ICMJE |
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| Intervention ICMJE | Behavioral: Workshop
The first 15 minutes will be an information session on either Urinary Incontinence (UI) or Pelvic Organ Prolapse (PO) led by a Nurse Continence Advisor. The following 60 minutes will comprise a psychologist-led group discussion. The structured discussion will encourage participants to share experiences, thoughts, and feelings on pelvic floor disorders. Resistances and barriers to seeking treatment will be discussed. Decision-making processes will be explored. During the final 15 minutes, participants will be asked to complete a survey to evaluate the workshop. The survey will assess satisfaction with the information provided, quality of group discussion, comfort level with the group experience, and their satisfaction with the roles of the nurse continence advisor and psychologist. | |||
| Study Arms ICMJE |
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| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Actual Enrollment ICMJE | 80 | |||
| Original Estimated Enrollment ICMJE | Same as current | |||
| Actual Study Completion Date ICMJE | November 6, 2017 | |||
| Actual Primary Completion Date | May 2017 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Canada | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT02758561 | |||
| Other Study ID Numbers ICMJE | 20150564-01H | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE |
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| Responsible Party | Ottawa Hospital Research Institute | |||
| Study Sponsor ICMJE | Ottawa Hospital Research Institute | |||
| Collaborators ICMJE | Pfizer | |||
| Investigators ICMJE |
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| PRS Account | Ottawa Hospital Research Institute | |||
| Verification Date | March 2019 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||