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

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 ris...

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Autores principales: Jaffar, Aida, Mohd Sidik, Sherina, Foo, Chai Nien, Muhammad, Noor Azimah, Abdul Manaf, Rosliza, Fadhilah Ismail, Siti Irma, Suhaili, Nazhatussima
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8125738/
https://www.ncbi.nlm.nih.gov/pubmed/33946203
http://dx.doi.org/10.3390/ijerph18094792
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author Jaffar, Aida
Mohd Sidik, Sherina
Foo, Chai Nien
Muhammad, Noor Azimah
Abdul Manaf, Rosliza
Fadhilah Ismail, Siti Irma
Suhaili, Nazhatussima
author_facet Jaffar, Aida
Mohd Sidik, Sherina
Foo, Chai Nien
Muhammad, Noor Azimah
Abdul Manaf, Rosliza
Fadhilah Ismail, Siti Irma
Suhaili, Nazhatussima
author_sort Jaffar, Aida
collection PubMed
description 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.
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spelling pubmed-81257382021-05-17 Protocol of a Single-Blind Two-Arm (Waitlist Control) Parallel-Group Randomised Controlled Pilot Feasibility Study for mHealth App among Incontinent Pregnant Women Jaffar, Aida Mohd Sidik, Sherina Foo, Chai Nien Muhammad, Noor Azimah Abdul Manaf, Rosliza Fadhilah Ismail, Siti Irma Suhaili, Nazhatussima Int J Environ Res Public Health Article 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. MDPI 2021-04-30 /pmc/articles/PMC8125738/ /pubmed/33946203 http://dx.doi.org/10.3390/ijerph18094792 Text en © 2021 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Jaffar, Aida
Mohd Sidik, Sherina
Foo, Chai Nien
Muhammad, Noor Azimah
Abdul Manaf, Rosliza
Fadhilah Ismail, Siti Irma
Suhaili, Nazhatussima
Protocol of a Single-Blind Two-Arm (Waitlist Control) Parallel-Group Randomised Controlled Pilot Feasibility Study for mHealth App among Incontinent Pregnant Women
title Protocol of a Single-Blind Two-Arm (Waitlist Control) Parallel-Group Randomised Controlled Pilot Feasibility Study for mHealth App among Incontinent Pregnant Women
title_full Protocol of a Single-Blind Two-Arm (Waitlist Control) Parallel-Group Randomised Controlled Pilot Feasibility Study for mHealth App among Incontinent Pregnant Women
title_fullStr Protocol of a Single-Blind Two-Arm (Waitlist Control) Parallel-Group Randomised Controlled Pilot Feasibility Study for mHealth App among Incontinent Pregnant Women
title_full_unstemmed Protocol of a Single-Blind Two-Arm (Waitlist Control) Parallel-Group Randomised Controlled Pilot Feasibility Study for mHealth App among Incontinent Pregnant Women
title_short Protocol of a Single-Blind Two-Arm (Waitlist Control) Parallel-Group Randomised Controlled Pilot Feasibility Study for mHealth App among Incontinent Pregnant Women
title_sort protocol of a single-blind two-arm (waitlist control) parallel-group randomised controlled pilot feasibility study for mhealth app among incontinent pregnant women
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8125738/
https://www.ncbi.nlm.nih.gov/pubmed/33946203
http://dx.doi.org/10.3390/ijerph18094792
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