Quality of LifeQoLNCT05777382
Quality of Life of Postnatal Mothers Attending Maternal and Child Health Clinic in Biratnagar
An observational study of Quality of Life, run by Tribhuvan University, Nepal at 1 site in Nepal.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Quality of Life
- What is being tested?
- inquiry to postnatal mothers
- How many people
- 129 participants
- Where
- 1 siteNepal
- Study dates
- 12 Aug 2018to 15 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: The study population included the mothers who attended the MCH clinic from post-delivery to 12 months post-delivery
Who may be able to join
- The study population included the mothers who attended the MCH clinic from post-delivery to 12 months post-delivery
Who cannot join
- Mothers with psychiatric disorders were excluded from the study population.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Quality of Life
- Being tested
- inquiry to postnatal mothers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inquiry to postnatal mothersOther
structured questionnaires was asked to postnatal mothers
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life in Post delivery mothers using RAND 36-Item Short Form Health Survey (SF-36)
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2023
- Study start12 Aug 2018
- Primary completion12 Oct 2018
- Study completion15 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tribhuvan University, Nepal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pratiksha Chapagain, Tribhuvan University, Nepal
- Investigators
- Pratiksha Chapagain, MSc Nursing, Principal investigator, Maharajgunj Nursing Campus, Tribhuvan University, Institute of Medicine, Kathmandu, Nepal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05777382
- Sponsor's protocol ID
- 131(6-N-E)2/075/076
- Acronym
- QoL
- Status last verified
- Mar 2023
- First submitted
- 18 Feb 2023
- Last updated
- 21 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life of Postnatal Mothers Attending Maternal and Child Health Clinic in Biratnagar
- ClinicalTrials.gov ID
- NCT05777382
- Acronym / sponsor ID
- QoL / 131(6-N-E)2/075/076
- Conditions
- Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Tribhuvan University, NepalUniversity, hospital or other
- Study start
- 12 Aug 2018 (actual)
- Primary completion
- 12 Oct 2018 (actual)
- Study completion
- 15 Apr 2019 (actual)
- First posted
- 21 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- The study population included the mothers who attended the MCH clinic from post-delivery to 12 months post-delivery
Key inclusion criteria (1 listed)
- The study population included the mothers who attended the MCH clinic from post-delivery to 12 months post-delivery
Key exclusion criteria (1 listed)
- Mothers with psychiatric disorders were excluded from the study population.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| inquiry to postnatal mothersstructured questionnaires was asked to postnatal mothers | Other | – |
Primary outcome
Quality of Life in Post delivery mothers using RAND 36-Item Short Form Health Survey (SF-36)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pratiksha Chapagain, MSc Nursing principal investigator
Maharajgunj Nursing Campus, Tribhuvan University, Institute of Medicine, Kathmandu, Nepal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life, run by Tribhuvan University, Nepal at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life in Post delivery mothers using RAND 36-Item Short Form Health Survey (SF-36) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2023.