- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05777382
Quality of Life of Postnatal Mothers Attending Maternal and Child Health Clinic in Biratnagar (QoL)
Objectives: Assessing health-related quality of life (HRQoL) and its predictors is essential for providing adequate healthcare and developing necessary interventions in women post-delivery. This study intended to determine the HRQoL score and predictors among women post-delivery in Nepal.
Methodology: This was a cross-sectional study using non-probability sampling conducted at the Maternal and Child Health (MCH) Clinic of Koshi Hospital, Province 1, Nepal. The study participants were 129 women post-delivery to 12 months who visited the MCH clinic from 2 September 2018 to 28 September 2018. Outcome measures were socio-demographic, clinical indicators, obstetric indicators, and their relation with overall health-related quality of life score of post-delivery mothers using Short Form Health Survey (SF-36) Version 1.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This cross-sectional study involved women post-delivery to 12 months who visited the Maternal and Child Health (MCH) Clinic of Koshi Hospital, Province 1, Nepal. The study population included the mothers who attended the MCH clinic from post-delivery to 12 months post-delivery. Mothers with psychiatric disorders were excluded from the study population. The investigators used a non-probability purposive sampling technique to select mothers meeting the inclusion criteria. The investigators used Short Form Health Survey (SF-36) Version 1.0 to assess study participants' HRQoL after obtaining permission for Research and Development (RAND). RAND SF-36 was already validated for use in Nepal by Bhandari et al. However, the investigators again pretested the translated Nepali SF-36 among 13 mothers in the MCH Clinic of Tribhuvan University Teaching Hospital. Cronbach's alpha was used to test the reliability, and the reported value was 0.752. Patient participants were involved in the study's pretesting. However, there was no public involvement in the research.
Independent variables: Age of mother, education status, ethnicity, religion, occupation, family income, type of family, family support, parity, number of living children, the desirability of pregnancy, mode of delivery, postpartum duration, place of delivery, and complications in recent delivery.
Dependent variable: Overall health-related quality of life score of post-delivery mothers were used.
Data was collected through face-to-face interviews using the RAND SF-36 Nepali version questionnaire from 2 September 2018 to 28 September 2018. The investigators collected a total of 129 responses. Descriptive statistics, i.e., number, percentage, mean, and standard deviation, were used to describe the demographic and obstetric variables. Mann-Whitney U test was applied to compare postnatal mothers' quality of life in different delivery modes. Similarly, Krushkal-Wallis H and Mann-Whitney U tests were used to examine the difference between the quality of life of postnatal mothers with selected socio-demographic and obstetric variables. Statistical significance was considered with a p-value ≤ 0.05.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Province 1
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Biratnagar, Province 1, Nepal, 56700
- Koshi Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- The study population included the mothers who attended the MCH clinic from post-delivery to 12 months post-delivery
Exclusion Criteria:
- Mothers with psychiatric disorders were excluded from the study population.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of Life in Post delivery mothers using RAND 36-Item Short Form Health Survey (SF-36)
Time Frame: 3 months
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Quality of life in Post delivery mothers using RAND 36-Item Short Form Health Survey ranging from 0 to 100, with higher score meaning better quality of life
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3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Pratiksha Chapagain, MSc Nursing, Maharajgunj Nursing Campus, Tribhuvan University, Institute of Medicine, Kathmandu, Nepal
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 131(6-N-E)2/075/076
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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