Kegel Exercise Pregnant Training mHealth App

Not Applicable

Completed

• Conditions: Pregnancy Related; Urinary Incontinence
• Interventions: Device: Kegel Exercise Pregnancy Training - app

• Registration Number: NCT04762433
• Lead Sponsor: Universiti Putra Malaysia

Brief Summary

This pilot feasibility study protocol is to assess the feasibility in the future definitive trial that is the Kegel Exercise Pregnancy Training app (KEPT-app) trial. The aim of this study as follows: (1) to evaluate the recruitment capability of the pregnant women, (2) to evaluate the acceptability of the KEPT-app, (3) to determine the implementation feasibility of using KEPT-app, and (4) to determine the preliminary effectiveness of KEPT-app to improve PFMT skills of pregnant women.

Detailed Description

The aim of this pilot feasibility study as follows: (1) to evaluate the recruitment capability of the pregnant women, (2) to evaluate the acceptability of the KEPT-app, (3) to determine the implementation feasibility of using KEPT-app, and (4) to determine the preliminary effectiveness of KEPT-app to improve PFMT skills of pregnant women.

Study Timeline

• Study First Submitted: 2021-02-09
• Study First Submitted QC: 2021-02-16
• Study First Posted: 2021-02-21
• Study Start: 2021-05-17
• Primary Completion: 2021-11-17
• Study Completion: 2021-11-17
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-22
• Last Update Posted: 2022-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 26

Inclusion Criteria

• Pregnant women at 26-27 weeks of gestation, any parity with either stress UI or mixed UI will be included.
• Participants are Malaysian citizens who consist of Malay, Chinese, Indian, and native ethnicities.

Exclusion Criteria

• pregnant women with a chronic medical problem(s) before pregnancy, complicated pregnancies or conditions which are not advisable to practise PFMT will be excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Kegel Exercise Pregnancy Training - App	Kegel Exercise Pregnancy Training - app	The intervention arm will be given a mHealth app for two months duration with the usual antenatal follow-up.

Primary Outcome Measures

Name	Time	Method
Acceptability of the mHealth app intervention.	2 months	Interactive Malay-mHealth App Usability Questionnaire Standardized outcome measure with additional Qualitative data collection; 1. How many stars would you recommend this app to your friends?; 2. How many stars would you rate the content of this app?; 3. How many stars would you rate the comfort of using this app?; 4. How many stars would you rate simplicity using this app?; 5. How many stars would you rate the recruitment process using this app?; 6. How many stars would you rate the quality of the app?; 7. Factors influenced/hindered using this app?; 8. What motivates you to continue the PFMT? (Further information will be collected via qualitative data feedback)

Secondary Outcome Measures

Name	Time	Method
Validation of educational video	1 month	Patient Educational Material Assessment Tool (PEMAT) Standardized outcome measure
Self-efficacy towards Kegel's Exercise	1 month and 2 months	Self-Efficacy Scale For Practicing Pelvic Floor Exercise Questionnaire Standardized outcome measure The final scores were obtained by calculating the mean of the items, ranging between 0 and 100, in which the higher values were equivalent to higher self-efficacy in practising PFME.
Urinary incontinence	1 month and 2 months	International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) The overall score is between 0 and 21 whereby greater values of the overall scores indicated increased severity of UI.
Kegel's exercise adherence	1 month and 2 months	Exercise Adherence Rating Scale Standardized outcome measure where the increasing PFMT adherence from lowest score (0) to maximum score (24) of Exercise Adherence Rating Scale (EARS) Increasing Exercise adherence from lowest score (0) to maximum score (24).
Knowledge, Attitude and Practice Pelvic Floor Muscle Training	1 month and 2 months	The overall knowledge scores ranged between 0 and 14, and a higher score suggested a higher level of knowledge. The total scores for attitude ranged between 8 and 40, with higher scores suggesting a positive attitude. The total scores for the practice domain ranged between 4 and 16, and the higher score suggested higher levels of its practice.
Quality of Life of pregnant women	1 month and 2 months	The minimum mark was 19 and the maximum mark was 76 indicating severely affecting QOL using the Incontinence Impact Questionnaire Quality of Life (ICIQ-LUTSqol).

Trial Locations

Locations (1)

(Health Clinic Ampang) Ministry of Health; 🇲🇾 Hulu Langat, Selangor, Malaysia