QoL: Quality of Life of Postnatal Mothers Attending Maternal and Child Health Clinic in Biratnagar

Sponsor
Tribhuvan University, Nepal (Other)
Overall Status
Completed
CT.gov ID
NCT05777382
Collaborator
(none)
129
1
8.1
16

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: inquiry to postnatal mothers

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 Design

Study Type:
Observational
Actual Enrollment :
129 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
Quality of Life of Postnatal Mothers Attending Maternal and Child Health Clinic in Biratnagar
Actual Study Start Date :
Aug 12, 2018
Actual Primary Completion Date :
Oct 12, 2018
Actual Study Completion Date :
Apr 15, 2019

Outcome Measures

Primary Outcome Measures

  1. Quality of Life in Post delivery mothers using RAND 36-Item Short Form Health Survey (SF-36) [3 months]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Koshi Hospital Biratnagar Province 1 Nepal 56700

Sponsors and Collaborators

  • Tribhuvan University, Nepal

Investigators

  • Principal Investigator: Pratiksha Chapagain, MSc Nursing, Maharajgunj Nursing Campus, Tribhuvan University, Institute of Medicine, Kathmandu, Nepal

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Pratiksha Chapagain, Principal Investigator, Tribhuvan University, Nepal
ClinicalTrials.gov Identifier:
NCT05777382
Other Study ID Numbers:
  • 131(6-N-E)2/075/076
First Posted:
Mar 21, 2023
Last Update Posted:
Mar 21, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Mar 21, 2023