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Completed

NCT Number: NCT04762433

Kegel Exercise Pregnant Training mHealth App

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.

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Key information

Conditions

Pregnancy Related Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

(Health Clinic Ampang) Ministry of Health

Hulu Langat, Selangor, 43200, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Kegel Exercise Pregnancy Training - app

Device

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.

Primary outcomes

  1. Acceptability of the mHealth app intervention.

    Time frame: 2 months

    Interactive Malay-mHealth App Usability Questionnaire Standardized outcome measure with additional Qualitative data collection

    • How many stars would you recommend this app to your friends?
    • How many stars would you rate the content of this app?
    • How many stars would you rate the comfort of using this app?
    • How many stars would you rate simplicity using this app?
    • How many stars would you rate the recruitment process using this app?
    • How many stars would you rate the quality of the app?
    • Factors influenced/hindered using this app?
    • What motivates you to continue the PFMT? (Further information will be collected via qualitative data feedback)

Secondary outcomes

  1. Validation of educational video

    Time frame: 1 month

    Patient Educational Material Assessment Tool (PEMAT) Standardized outcome measure

  2. Kegel's exercise adherence

    Time frame: 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).

  3. Self-efficacy towards Kegel's Exercise

    Time frame: 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.

  4. Urinary incontinence

    Time frame: 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.

  5. Knowledge, Attitude and Practice Pelvic Floor Muscle Training

    Time frame: 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.

  6. Quality of Life of pregnant women

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Universiti Putra Malaysia

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 21, 2021
Registry last updated
Apr 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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