Pelvic Floor Disorder Education in Prenatal Care
Primary Purpose
Pelvic Floor Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Education Video
Sponsored by
About this trial
This is an interventional other trial for Pelvic Floor Disorders focused on measuring Pelvic floor disorders, Education, Prenatal education, Video education
Eligibility Criteria
Inclusion Criteria:
- Women 18 years or older in their third trimester of pregnancy (37 weeks of gestation or greater)
- English-speaking
Exclusion Criteria:
- Non-English-speaking patients
- Gestational age < 37 weeks
Sites / Locations
- Icahn School of Medicine at Mount Sinai
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control Group
Video Group
Arm Description
Control participants will only complete the knowledge questionnaire in addition to a non-validated survey created by the investigators to collect demographic information as well as attitudes towards treatments of pelvic floor disorders.
These participants will be administered the study intervention, which entails viewing an education video on pelvic floor disorders.
Outcomes
Primary Outcome Measures
Change in Prolapse and Incontinence Knowledge Questionnaire
The questionnaire is divided into two separate 12-item subscales on urinary incontinence (PIKQ-UI) and prolapse (PIKQ-POP). Subscales from 0 to 12. Total scale from 0-24. A higher score indicates higher proficiency.
Secondary Outcome Measures
Full Information
NCT ID
NCT05127512
First Posted
October 28, 2021
Last Updated
May 26, 2022
Sponsor
Icahn School of Medicine at Mount Sinai
1. Study Identification
Unique Protocol Identification Number
NCT05127512
Brief Title
Pelvic Floor Disorder Education in Prenatal Care
Official Title
Pelvic Floor Disorder Education in the Prenatal Period, a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
October 25, 2021 (Actual)
Primary Completion Date
May 9, 2022 (Actual)
Study Completion Date
May 9, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Floor Disorders
Keywords
Pelvic floor disorders, Education, Prenatal education, Video education
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
94 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Control participants will only complete the knowledge questionnaire in addition to a non-validated survey created by the investigators to collect demographic information as well as attitudes towards treatments of pelvic floor disorders.
Arm Title
Video Group
Arm Type
Experimental
Arm Description
These participants will be administered the study intervention, which entails viewing an education video on pelvic floor disorders.
Intervention Type
Other
Intervention Name(s)
Education Video
Intervention Description
A 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.
Primary Outcome Measure Information:
Title
Change in Prolapse and Incontinence Knowledge Questionnaire
Description
The questionnaire is divided into two separate 12-item subscales on urinary incontinence (PIKQ-UI) and prolapse (PIKQ-POP). Subscales from 0 to 12. Total scale from 0-24. A higher score indicates higher proficiency.
Time Frame
Baseline, 1 day ( the time of enrollment) and at 6-8 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Women 18 years or older in their third trimester of pregnancy (37 weeks of gestation or greater)
English-speaking
Exclusion Criteria:
Non-English-speaking patients
Gestational age < 37 weeks
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chandhu Paka, MD
Organizational Affiliation
Mount Sinai West
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
IPD Sharing Time Frame
Immediately following publication. No end date.
IPD Sharing Access Criteria
Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. For individual participant data meta-analysis. Proposals should be directed to bhgaigbe@gmail.com. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website tbd.
Citations:
PubMed Identifier
24807341
Citation
Wu JM, Matthews CA, Conover MM, Pate V, Jonsson Funk M. Lifetime risk of stress urinary incontinence or pelvic organ prolapse surgery. Obstet Gynecol. 2014 Jun;123(6):1201-1206. doi: 10.1097/AOG.0000000000000286.
Results Reference
background
PubMed Identifier
27171319
Citation
Hyakutake MT, Han V, Cundiff GW, Baerg L, Koenig NA, Lee T, Geoffrion R. Pelvic Floor Health Education: Can a Workshop Enhance Patient Counseling During Pregnancy? Female Pelvic Med Reconstr Surg. 2016 Sep-Oct;22(5):336-9. doi: 10.1097/SPV.0000000000000285.
Results Reference
background
PubMed Identifier
19517050
Citation
Geoffrion R, Robert M, Ross S, van Heerden D, Neustaedter G, Tang S, Milne J. Evaluating patient learning after an educational program for women with incontinence and pelvic organ prolapse. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Oct;20(10):1243-52. doi: 10.1007/s00192-009-0919-5. Epub 2009 Jun 11.
Results Reference
background
PubMed Identifier
20093900
Citation
Howell EA. Lack of patient preparation for the postpartum period and patients' satisfaction with their obstetric clinicians. Obstet Gynecol. 2010 Feb;115(2 Pt 1):284-289. doi: 10.1097/AOG.0b013e3181c8b39b.
Results Reference
background
PubMed Identifier
30783706
Citation
Liu J, Tan SQ, Han HC. Knowledge of pelvic floor disorder in pregnancy. Int Urogynecol J. 2019 Jun;30(6):991-1001. doi: 10.1007/s00192-019-03891-3. Epub 2019 Feb 19.
Results Reference
background
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Pelvic Floor Disorder Education in Prenatal Care
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