NCT04762433

Kegel Exercise Pregnant Training mHealth App

Parallel-Group, Randomised Single-centred, Single-blind, Pilot and Feasibility Study for KEPT-app Trial: Study Protocol

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Universiti Putra Malaysia · Academic / Other
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pregnancy Related
• Urinary Incontinence

Interventions

Type	Name	Description
DEVICE	Kegel Exercise Pregnancy Training - app	KEPT-app is designed to educate pregnant women on PFMT via the step-by-step training with the capability element to improve their confidence and skills (beginner, intermediate and advance skills). Pregnant women are encouraged to continue adopt the PFMT throughout pregnancy until postpartum period. The details of the mHealth app content was developed based on the need assessment gathered from the cross-sectional study (Jaffar et al., 2020). It was conducted to identify the need of PFMT by looking at the prevalence of the UI among pregnant women and to understand their knowledge, attitude, and practices towards PFMT.

Timeline

• Start date: 2021-05-17
• Primary completion: 2021-11-17
• Completion: 2021-11-17
• First posted: 2021-02-21
• Last updated: 2022-04-04

Locations

1 site across 1 country: Malaysia