Patient Educational Video for Pelvic Organ Prolapse

NCT04996563 | Completed

• 1 other identifier: 2021H0064
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-blinded, randomized controlled trial investigating if a patient educational video on pelvic organ prolapse improves patient understanding of this pelvic floor disorder and satisfaction in their healthcare decision making for its management.

Conditions

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (1)

• Difference in SDS-PFD score

  The difference in the score of a validated decision satisfaction questionnaire, the Satisfaction with Decision Scale for Pelvic Floor Disorders (SDS-PFD), will be compared between the two arms. A difference of 0.4 will be considered clinically meaningful. The SDS-PFD was modified from the original SDS to be specific for women making decisions regarding surgical treatment for PFD. It has 6 questions with a 5-point response scale. The score is calculated by taking the mean of the 6 answers (1-5). Higher scores correspond with higher satisfaction.

  Within 1 day of completion of the initial visit

Secondary Outcomes (6)

• Difference in DCS score

  Within 1 day of completion of the initial visit

• Difference in PIKQ-POP score

  Within 1 day of completion of the initial visit

• Patient perception of their knowledge

  Within 1 day of completion of the initial visit

• Physician's perception of patient's understanding of prolapse

  Within 1 day of completion of the initial visit

• Difference in SDS-PFD scores after management of prolapse

  Within 2 weeks to 1 year after undergoing the chosen management option

Study Arms (2)

Video

EXPERIMENTAL

A brief educational video on POP will be sent electronically to participants randomized to the video group. Participants will view the video within one week prior to their consultation visit.

Other: Video

No video

NO INTERVENTION

Participants assigned to this group will not be sent the educational video to view.

Interventions

Video OTHER

A brief educational video, approximately 9 minutes in duration, on pelvic organ prolapse is sent electronically to patients to view prior to their initial visit in order to provide early access to information. The video was created to educate patients on the following key components of prolapse: the clinical condition, associated symptoms, common risk factors, evaluation and diagnosis, non-surgical treatment options, and surgical treatment options. Simple drawings and animations are included as visual aids to enhance the ability to conceptualize prolapse and its management options.

Video

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Initial evaluation for symptomatic POP
• Age greater than or equal to 18 years old
• Reliable access to text or e-mail

You may not qualify if:

• Pregnant women
• Presence of cognitive disability
• Non-English speaking patient or requiring interpreter assistance
• Women with a history of prior pelvic organ prolapse therapy, i.e. pelvic floor physical therapy, pessary, or surgical repair

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Interventions

Videotape Recording

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tape Recording; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture; Television

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Patients are asked not to unmask themselves at their visit to any staff or their care provider.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants are randomly assigned prospectively to one of two interventions to evaluate the effect of the educational video intervention on their knowledge of prolapse and satisfaction in their healthcare decision making for management of prolapse.

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: August 9, 2021
• Study Start: August 2, 2021
• Primary Completion: May 17, 2022
• Study Completion: December 12, 2022
• Last Updated: May 12, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)