Motivational Interviewing in Women's Pelvic Wellness Education

NCT02758561 | Completed

• 1 other identifier: 20150564-01H
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Floor Disorders; Urinary Incontinence (UI); Pelvic Prolapse Conditions

Keywords

decisional aid; workshops; urinary incontinence; pelvic organ prolapse; pelvic floor dysfunction; decisional conflict

Outcome Measures

Primary Outcomes (1)

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

  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.

  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.

Secondary Outcomes (1)

• Participant satisfaction with the workshop.

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

Study Arms (2)

Standard of care

NO INTERVENTION

Standard of care

Workshop

EXPERIMENTAL

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

Behavioral: Workshop

Interventions

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.

Workshop

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• Pfizer: collaborator

Study Sites (1)

The Ottawa Hospital, Riverside Campus

Ottawa, Ontario, K1H 7W9, Canada

Location

MeSH Terms

Conditions

Pelvic Floor Disorders; Urinary Incontinence; Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases; Urination Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Prolapse; Pathological Conditions, Anatomical

Study Officials

• Joyce Schachter, MD, FRCSC

  The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2015
• First Posted: May 2, 2016
• Study Start: May 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: November 6, 2017
• Last Updated: March 21, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)