None listed
Conditions
Brief summary
This study aimed to develop, implement and evaluate the effectiveness of PFME intervention based on SCT and MI relating specifically to PFME knowledge, attitude, practice and self-efficacy, continence status and the severity of UI symptoms among pregnant women in Hulu Langat, Malaysia. Hypothesis for this research is mHealth-app is effective in improving urinary incontinence among pregnant women. A two-armed, cluster-randomized control trial with a single-blind design will be conducted in ten government health clinics in Hulu Langat, Selangor. The respondents who were eligible to partake in this study were randomly assigned to either the intervention or control groups. The intervention group will receive mHealth app with educational videos, timer for training sessions, progress chart and assessment questionnaire. The control group will receive a "placebo app" that has only assessment questionnaires. Both groups will be receiving routine antenatal care from their clinics.
Interventions
The objectives for the KEPT-App trial are to determine whether if the intervention group (KEPT-app) is superior to the control group (waitlist) in urinary incontinence (UI) among pregnant women. Both arms (intervention and control) will receive standard antenatal care as being practice in all antenatal clinics in Malaysia.
Participants will be recruited from ten government health care clinics in the Hulu Langat district, which belongs to the Selangor state in Malaysia. Selangor is known as most
The objectives for the KEPT-App trial are to determine whether if the intervention group (KEPT-app) is superior to the control group (waitlist) in urinary incontinence (UI) among pregnant women. Both arms (intervention and control) will receive standard antenatal care as being practice in all antenatal clinics in Malaysia. Participants will be recruited from ten government health care clinics in the Hulu Langat district, which belongs to the Selangor state in Malaysia. Selangor is known as most Malaysia's most populated state and has the nation's biggest urban area, which is the Klang Valley which includes Hulu Langat district. The total number of participants in this trial is 368. In addition, to reduce the selection bias, an extra step of stratified methods will be added to improve recruitment. The RA will recruit the participants according to the proportion of the clinic’s pregnant women's attendance. The intervention group received the newly developed pelvic floor muscle training (PFMT) intervention which developed based on the Capability Opportunity and Motivation – Behaviour Model (COM-B) in addition to the usual prenatal care via KEPT-apps. The PFMT intervention consisted of PFMT education sessions delivered started at baseline, a reminder notification and three booster sessions at the week 4 post-education session, early third-trimester, and late third-trimester and 8 weeks postpartum. The total duration of the intervention is 20 weeks, with at least 3 minutes per session and 9 minutes per day, three times daily per week for the intervention arm. Participants will perform their PFMT according to mobile app instruction. The education on how to perform PFMT will be delivered via an educational video available embedded from the KEPT app. The video consisted of an Educational and Training video (total 6 minutes). The participants must watch these two videos before they started the PFMT. The physiotherapist from a tertiary centre was involved in the explanation and demonstrating the correct way of PFMT in the video. Participants will be reminded of the exercise routine via reminder or notification from the app.
Sponsors
Universiti Putra Malaysia (Research and Innovation Dept)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
Participants are Malaysian, pregnant women at 26-27 weeks’ gestation, UI with a score of more than three on (ICIQ-UI-SF) questionnaire, are motivated for participation in this programme, with a singleton pregnancy, and who give informed consent. The participants must have a smartphone with a wifi availability
Exclusion criteria
Participants who are excluded from this study are those who are pregnant women aged 17 years and below, urge incontinence, non-Malaysian pregnant women or pregnant women undergoing physiotherapy treatment for severe urinary incontinence. Pregnant women who have complicated pregnancy and chronic medical problems prior to pregnancy such as diabetes, hypertension, HIV positive, neurological condition, pelvic organ prolapse will not be included. Pregnant women who have contraindications to the practice of physical activity for example preeclampsia, persistent bleeding, pre-term labor, incompetent cervix, acute febrile infection, and fetal growth restriction or placenta previa, cephalopelvic disproportion and previous urogenital surgery will not be included.
Outcome results
None listed