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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
26
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.
(Health Clinic Ampang) Ministry of Health
Hulu Langat, Selangor, Malaysia
Acceptability of the mHealth app intervention.
Interactive Malay-mHealth App Usability Questionnaire Standardized outcome measure with additional Qualitative data collection 1. How many stars would you recommend this app to your friends? 2. How many stars would you rate the content of this app? 3. How many stars would you rate the comfort of using this app? 4. How many stars would you rate simplicity using this app? 5. How many stars would you rate the recruitment process using this app? 6. How many stars would you rate the quality of the app? 7. Factors influenced/hindered using this app? 8. What motivates you to continue the PFMT? (Further information will be collected via qualitative data feedback)
Time frame: 2 months
Validation of educational video
Patient Educational Material Assessment Tool (PEMAT) Standardized outcome measure
Time frame: 1 month
Kegel's exercise adherence
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).
Time frame: 1 month and 2 months
Self-efficacy towards Kegel's Exercise
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.
Time frame: 1 month and 2 months
Urinary incontinence
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.
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Time frame: 1 month and 2 months
Knowledge, Attitude and Practice Pelvic Floor Muscle Training
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.
Time frame: 1 month and 2 months
Quality of Life of pregnant women
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).
Time frame: 1 month and 2 months