Clinical Trials Directory

Trials / Completed

CompletedNCT05127512

Pelvic Floor Disorder Education in Prenatal Care

Pelvic Floor Disorder Education in the Prenatal Period, a Randomized Controlled Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
94 (actual)
Sponsor
Icahn School of Medicine at Mount Sinai · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Accepted

Summary

Pelvic floor disorders (PFDs) are common conditions that can have significant impacts on patients' quality of life and psychosocial well-being. It is well known that patients who have experienced pregnancy and childbirth are at risk of developing these conditions, either during pregnancy, postpartum, or later in life. However, many women are unaware of this predisposing risk factor. Additionally, overall knowledge of these conditions is low in both the general and obstetrics population. Video education has been used in various fields with success in improving patient knowledge of specific topics and conditions. To the researchers' knowledge, no studies have evaluated this modality for educating obstetrics patients on PFDs. The aim of this study is to determine whether the use of an educational video will improve knowledge of PFDs compared to routine prenatal counseling, using a validated knowledge questionnaire.

Detailed description

Once verbal consent is obtained, participants will be randomly assigned in a 1:1 ratio to the intervention (video education) or control group (routine prenatal visit only). Group assignments will be performed using computer-generated randomization. All participants will complete a paper questionnaire including basic demographic information, prior history of pelvic floor disorders, and current PFD symptoms. Participants assigned to the routine prenatal visit only will be instructed to complete the Prolapse and Incontinence Knowledge Questionnaire (PIKQ). The PIKQ is a validated 24-item questionnaire designed to assess knowledge of PFDs, including two 12-item subscales on urinary incontinence (PIKQ-UI) and prolapse (PIKQ-POP).

Conditions

Interventions

TypeNameDescription
OTHEREducation VideoA 6.47-minute education video was created by the research group based on American Urogynecology Society (AUGS) and International Urogynecologic Association (IUGA) patient education pamphlets. Participants in the intervention group will be asked to watch this video after completing a baseline knowledge questionnaire of pelvic floor disorders.

Timeline

Start date
2021-10-25
Primary completion
2022-05-09
Completion
2022-05-09
First posted
2021-11-19
Last updated
2022-05-27

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05127512. Inclusion in this directory is not an endorsement.