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NOT YET RECRUITING
NCT06432218
NA

Patient Education in the Clinical Management of Pessary

Sponsor: Peking Union Medical College Hospital

View on ClinicalTrials.gov

Summary

This study is a prospective, randomized, controlled, single-blinded, multi-center clinical trial. Symptomatic patients with pelvic organ prolapse (POP) stage II, III or IV arranged to undergo pessary treatment will be randomized into either the experimental group or the control group. All patients will receive conventional verbal/paper instruction and counseling from a specialized doctor or nurse before pessary fitting, and the experimental group will receive additional patient education in the form of a re-watchable video. The video mainly includes a short introduction of pessary treatment for pelvic organ prolapse, tips and tricks for wearing and self-management of pessary, possible adverse reactions and remedy. All patients will receive regular pessary fitting and be followed up for 1 year. Self-assessment questionnaires will be used to assess the patients' willingness to pessary treatment, anxiety status, treatment satisfaction and efficacy, and to assess the patients' self-management, complications and treatment adherence. Then the differences between the two groups will be compared.

Official title: A Randomized Controlled Trial of the Effectiveness of Patient Education in the Clinical Management of Pessary

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

280

Start Date

2024-06

Completion Date

2026-11

Last Updated

2024-05-29

Healthy Volunteers

No

Interventions

OTHER

video education

A re-watchable video provided before pessary fitting which mainly includes a short introduction of pessary treatment for pelvic organ prolapse, tips and tricks for wearing and self-management of pessary, possible adverse reactions and remedy.

OTHER

conventional education

Conventional verbal/paper instruction and counseling from a specialized doctor or nurse before pessary fitting.

Locations (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China