Protocol of a Single-Blind Two-Arm (Waitlist Control) Parallel-Group Randomised Controlled Pilot Feasibility Study for mHealth App among Incontinent Pregnant Women

Aida Jaffar, Sherina Mohd Sidik, Chai Nien Foo, Noor Azimah Muhammad, Rosliza Abdul Manaf, Siti Irma Fadhilah Ismail and Nazhatussima Suhaili
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Aida Jaffar: Department of Psychiatry, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Seri Kembangan 43400, Malaysia
Sherina Mohd Sidik: Department of Psychiatry, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Seri Kembangan 43400, Malaysia
Chai Nien Foo: Department of Population Medicine, Universiti Tunku Abdul Rahman, Kajang 43000, Malaysia
Noor Azimah Muhammad: Department of Family Medicine, Faculty of Medicine, Universiti Kebangsaan Malaysia, Wilayah Persekutuan Kuala Lumpur 56000, Malaysia
Rosliza Abdul Manaf: Department of Community Health, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Seri Kembangan 43400, Malaysia
Siti Irma Fadhilah Ismail: Department of Psychiatry, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Seri Kembangan 43400, Malaysia
Nazhatussima Suhaili: Klinik Kesihatan Ampang, Ampang 68000, Malaysia

IJERPH, 2021, vol. 18, issue 9, 1-12

Abstract: Background: The delivery of pelvic floor muscle training (PFMT) through mHealth apps has been shown to produce promising results in improving pelvic floor muscle strength and urinary incontinence (UI). However, there is limited evidence on mHealth apps designed for pregnant women who are at high risk of developing UI. This pilot study aims to evaluate the feasibility of conducting an effectiveness trial for a newly developed PFMT app among pregnant women in Malaysia. Methods: This is a prospective, single-centre, single-blind, randomised controlled pilot feasibility study: The Kegel Exercise Pregnancy Training app (KEPT-app) Trial. Sixty-four incontinent pregnant women who attended one primary care clinic for the antenatal follow-up will be recruited and randomly assigned to either intervention or waitlist control group. The intervention group will receive the intervention, the KEPT-app developed from the Capability, Opportunity, Motivation-Behaviour (COM-B) theory with Persuasive Technology and Technology Acceptance Model. Discussion: This study will provide a fine-tuning for our future randomised control study on the recruitment feasibility methods, acceptability, feasibility, and usability of the KEPT-app, and the methods to reduce the retention rates among pregnant women with UI. Trial registration: This study was registered on ClinicalTrials.gov on 19 February 2021 (NCT04762433) and is not yet recruiting.

Keywords: mHealth app; mobile application; pelvic floor muscle training; urinary incontinence; pregnancy; behavioural change theory; randomized control trial; pilot feasibility study (search for similar items in EconPapers)
JEL-codes: I I1 I3 Q Q5 (search for similar items in EconPapers)
Date: 2021
References: View references in EconPapers View complete reference list from CitEc
Citations: View citations in EconPapers (3)

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