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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

Author

Listed:
  • Aida Jaffar

    (Department of Psychiatry, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Seri Kembangan 43400, Malaysia
    Primary Care Unit, Faculty of Medicine and Defence Health, Universiti Pertahanan Nasional Malaysia, Wilayah Persekutuan Kuala Lumpur 57000, 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)

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.

Suggested Citation

  • Aida Jaffar & Sherina Mohd Sidik & Chai Nien Foo & Noor Azimah Muhammad & Rosliza Abdul Manaf & Siti Irma Fadhilah Ismail & Nazhatussima Suhaili, 2021. "Protocol of a Single-Blind Two-Arm (Waitlist Control) Parallel-Group Randomised Controlled Pilot Feasibility Study for mHealth App among Incontinent Pregnant Women," IJERPH, MDPI, vol. 18(9), pages 1-12, April.
    • Handle: RePEc:gam:jijerp:v:18:y:2021:i:9:p:4792-:d:546751
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    References listed on IDEAS

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    1. Patrick S Moran & Francesca Wuytack & Michael Turner & Charles Normand & Stephanie Brown & Cecily Begley & Deirdre Daly, 2020. "Economic burden of maternal morbidity – A systematic review of cost-of-illness studies," PLOS ONE, Public Library of Science, vol. 15(1), pages 1-18, January.
    2. Noriaki Maeda & Yukio Urabe & Yuta Suzuki & Daigo Hirado & Masanori Morikawa & Makoto Komiya & Rami Mizuta & Koichi Naito & Taizan Shirakawa, 2021. "Cross-Sectional Study of the Prevalence and Symptoms of Urinary Incontinence among Japanese Older Adults: Associations with Physical Activity, Health-Related Quality of Life, and Well-Being," IJERPH, MDPI, vol. 18(2), pages 1-10, January.
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    Cited by:

    1. Aida Jaffar & Sherina Mohd Sidik & Chai Nien Foo & Noor Azimah Muhammad & Rosliza Abdul Manaf & Nazhatussima Suhaili, 2022. "Preliminary Effectiveness of mHealth App-Based Pelvic Floor Muscle Training among Pregnant Women to Improve Their Exercise Adherence: A Pilot Randomised Control Trial," IJERPH, MDPI, vol. 19(4), pages 1-14, February.
    2. Lei Gao & Di Zhang & Shiyan Wang & Yuanyuan Jia & Haibo Wang & Xiuli Sun & Jianliu Wang, 2021. "Effect of the App-Based Video Guidance on Prenatal Pelvic Floor Muscle Training Combined with Global Postural Re-education for Stress Urinary Incontinence Prevention: A Protocol for a Multicenter, Ran," IJERPH, MDPI, vol. 18(24), pages 1-10, December.
    3. Aida Jaffar & Noor Azimah Muhammad & Sherina Mohd Sidik & Novia Admodisastro & Rosliza Abdul Manaf & Chai Nien Foo & Nazhatussima Suhaili, 2022. "Feasibility and Usability of Kegel Exercise Pregnancy Training App (KEPT App) among Pregnant Women with Urinary Incontinence," IJERPH, MDPI, vol. 19(6), pages 1-11, March.

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