Motivational Interviewing in Women's Pelvic Wellness Education

NCT ID: NCT02758561

Last Updated: 2019-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2017-11-06

Brief Summary

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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

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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.

Conditions

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Pelvic Floor Disorders Urinary Incontinence (UI) Pelvic Prolapse Conditions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Standard of care

Standard of care

Group Type NO_INTERVENTION

No interventions assigned to this group

Workshop

90 minute workshop on either Urinary Incontinence (UI) or Pelvic Organ Prolapse (POP)

Group Type EXPERIMENTAL

Workshop

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

Ottawa Hospital Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joyce Schachter, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

The Ottawa Hospital

Locations

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The Ottawa Hospital, Riverside Campus

Ottawa, Ontario, Canada

Site Status

Countries

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Canada

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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20150564-01H

Identifier Type: -

Identifier Source: org_study_id

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