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Completed

NCT Number: NCT02758561

Motivational Interviewing in Women's Pelvic Wellness Education

This pilot study will assess the feasibility and acceptability of an educational workshop on pelvic floor disorders and its potential impact on decisional conflict.

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Key information

Conditions

Pelvic Floor Disorders Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Organ Prolapse Pelvic Prolapse Conditions Pregnancy Complications Prolapse Signs and Symptoms Urinary Incontinence Urinary Incontinence (UI) Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The Ottawa Hospital, Riverside Campus

Ottawa, Ontario, K1H 7W9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women ages >18 years old
  • Urinary incontinence and/or pelvic organ prolapse
  • First visit with urogynecologist

Exclusion criteria

  • 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

Treatment and study plan

Workshop

Behavioral

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.

Primary outcomes

  1. Change in "Decisional Conflict" between baseline and followup, as measured by the Decisional Conflict Scale (O'Connor 1995).

    Time frame: The Decisional Conflict Scale (DCS), will be administered to participants in the control and intervention groups at baseline and first follow up visit, approx. 3 months later.

    The decisional conflict scale (DCS) is a validated scale that measures (a) perceived uncertainty between options, (b) factors contributing to uncertainty (feeling uninformed, unclear about values, unsupported in decision making), and (c) factors contributing to effective decision making (feeling the choice is informed, values-based, likely to be implemented, and satisfaction with the decision). 13 A total decisional conflict score from 0 (no decisional conflict) to 100 (extremely high decisional conflict) is given, as well as five sub-scores for each factor listed above.

Secondary outcomes

  1. Participant satisfaction with the workshop.

    Time frame: This will be measured using a survey administered to participants immediately following the workshop

    Non-validated questionnaire addressing participants' perceived satisfaction with the following aspects of the workshop: group discussion, the information session, and the workshop as a whole. In addition there are four free text questions: 1) What changes will you make in your decision for treatment as a result of this workshop?; 2)Tell us about one thing you found most valuable in this workshop; 3)What would you change about this workshop?; 4) Other comments

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Collaborators

  • Pfizer

Registry information

Official study title

2015 Motivational Interviewing in Women's Pelvic Wellness Education Project

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 2, 2016
Registry last updated
Mar 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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