Infant DevelopmentNCT05721430
Urdu Translation and Cross Cultural Validation of PedsQL Inventory Infant Scale Parent Report 1 to 12 Months
An observational study of Infant Development, run by Riphah International University at 2 sites in Pakistan.
Trial summary
The current study aimed to translate and validate Urdu version of that module from PedsQL, to measure the "quality of life" outcomes for Pakistan and Urdu speaking people. Read more about this study
- Who is it for?
- Ages 1 month to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Infant Development
- How many people
- 43 participants
- Where
- 2 sitesPakistan
- Study dates
- 15 Feb 2023to 24 May 2023
- 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 1 month to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: The sample size was 43. Sample size was calculated by raosoft online software. Margin of error 5% Confidence level 95% Population size 20000 Response distribution 50% Sample Selection Criteria
Who may be able to join
- Parents of both genders included
- Parents of infant age 1 to 12 months were included.
Who cannot join
- Parents suffering from psychological disorders
- Parents with severe behavior issue
- Parents who cannot understand Urdu
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Riphah international university
Lahore, Punjab Province
Rising Sun Institute
Lahore, Punjab Province
About this study
Official title: Urdu Translation and Cross Cultural Validation of PedsQL Inventory Infant Scale Parent Report Ages 1 to 12 Months
The current study aimed to translate and validate Urdu version of that module from PedsQL, to measure the "quality of life" outcomes for Pakistan and Urdu speaking people.
Read the detailed description
Data will be collected by PedQL Infants Scale Parent report A mix method approach will be applied Forward translation Backward translation Review of forward and backward translation The process of translation will be followed the guidelines in the translation manual. Translators will translate the PedsQL Inventory Infants Scale Parent Report independently from each other in Urdu language following the proper forward and backward translation procedure.
Data Analysis Quality of life pediatric population will assess through Urdu translated version of PedsQL Inventory Infants Scale Parent report. Data will be analyzed through SPSS.
- Conditions
- Infant Development
- Keywords
- Health related quality of life of Infants
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life of Infants age 1 to 12 months
Urdu Translation and Cross Cultural Validation of PedsQL Inventory Infant Scale Parent Report 1 to 12 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start15 Feb 2023
- Primary completion24 May 2023
- Study completion24 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infant DevelopmentStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Asif Javed, Riphah International University
- Investigators
- Saiqa Tabassum, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05721430
- Sponsor's protocol ID
- saiqaT
- Status last verified
- Aug 2023
- First submitted
- 31 Jan 2023
- Last updated
- 9 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Varni JW, Limbers CA, Neighbors K, Schulz K, Lieu JE, Heffer RW, Tuzinkiewicz K, Mangione-Smith R, Zimmerman JJ, Alonso EM. The PedsQL Infant Scales: feasibility, internal consistency reliability, and validity in healthy and ill infants. Qual Life Res. 2011 Feb;20(1):45-55. doi: 10.1007/s11136-010-9730-5. Epub 2010 Aug 22.
PubMed 20730626
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urdu Translation and Cross Cultural Validation of PedsQL Inventory Infant Scale Parent Report Ages 1 to 12 Months
- ClinicalTrials.gov ID
- NCT05721430
- Acronym / sponsor ID
- saiqaT
- Conditions
- Infant Development
- Keywords
- Health related quality of life of Infants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 24 May 2023 (actual)
- Study completion
- 24 May 2023 (actual)
- First posted
- 10 Feb 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.
The current study aimed to translate and validate Urdu version of that module from PedsQL, to measure the "quality of life" outcomes for Pakistan and Urdu speaking people.
Detailed description
Data will be collected by PedQL Infants Scale Parent report A mix method approach will be applied Forward translation Backward translation Review of forward and backward translation The process of translation will be followed the guidelines in the translation manual. Translators will translate the PedsQL Inventory Infants Scale Parent Report independently from each other in Urdu language following the proper forward and backward translation procedure.
Data Analysis Quality of life pediatric population will assess through Urdu translated version of PedsQL Inventory Infants Scale Parent report. Data will be analyzed through SPSS.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 month to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The sample size was 43. Sample size was calculated by raosoft online software. Margin of error 5% Confidence level 95% Population size 20000 Response distribution 50% Sample Selection Criteria
Key inclusion criteria (2 listed)
- Parents of both genders included
- Parents of infant age 1 to 12 months were included.
Key exclusion criteria (3 listed)
- Parents suffering from psychological disorders
- Parents with severe behavior issue
- Parents who cannot understand Urdu
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quality of Life of Infants age 1 to 12 months
Time frame: 6 months
Urdu Translation and Cross Cultural Validation of PedsQL Inventory Infant Scale Parent Report 1 to 12 months
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 9 Aug 2023.
- Background: PubMed 20730626Varni JW, Limbers CA, Neighbors K, Schulz K, Lieu JE, Heffer RW, Tuzinkiewicz K, Mangione-Smith R, Zimmerman JJ, Alonso EM. The PedsQL Infant Scales: feasibility, internal consistency reliability, and validity in healthy and ill infants. Qual Life Res. 2011 Feb;20(1):45-55. doi: 10.1007/s11136-010-9730-5. Epub 2010 Aug 22.
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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.
Saiqa Tabassum, MS principal investigator
Riphah International University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infant Development, run by Riphah International University at 2 sites in Pakistan.
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 2 inclusion and 3 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 9 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. 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 of Infants age 1 to 12 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05721430, which also lists 1 linked publication.
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 9 Aug 2023.