- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07680062
Pain, Caregiver Burden, and Quality of Life in Mothers of Children With Disabilities
Relationship Between Pain Intensity, Caregiver Burden, and Quality of Life in Mothers of Children With Disabilities: A Cross-Sectional Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Mothers of children with disabilities are exposed to substantial physical and psychological demands due to long-term caregiving responsibilities. These challenges may negatively affect pain levels, caregiver burden, and quality of life. However, the relationships between these factors have not been sufficiently investigated.
This cross-sectional observational study aims to examine the associations between pain intensity, caregiver burden, and quality of life in mothers of children with disabilities. Pain intensity will be assessed using the Numeric Pain Scale (NPS), caregiver burden using the Zarit Caregiver Burden Scale, and quality of life using the Short Form-12 (SF-12), including physical and mental component scores. Pearson correlation and multiple linear regression analyses will be performed to determine the relationships between variables and identify independent determinants of quality of life.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Uskudar
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Istanbul, Uskudar, Turkey (Türkiye), 34662
- Uskudar University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Mothers aged 18 years and older who were the primary caregiver of a child with disabilities and who agreed to participate in the study were included.
Exclusion Criteria:
- Mothers with diagnosed neurological, rheumatological, or severe musculoskeletal disorders that could independently affect pain, physical activity, or quality of life were excluded.
- Mothers with cognitive impairment preventing questionnaire completion were also excluded
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Zarit Caregiver Burden Scale
Time Frame: baseline
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The Zarit Caregiver Burden Scale is a self-reported questionnaire used to evaluate the level of burden experienced by caregivers.
Higher scores indicate greater caregiver burden.
|
baseline
|
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Numeric Pain Scale (NPS)
Time Frame: baseline
|
The Numeric Pain Scale is an 11-point scale ranging from 0 (no pain) to 10 (worst imaginable pain) used to assess pain intensity.
|
baseline
|
|
Short Form-12 (SF-12)
Time Frame: baseline
|
The SF-12 is a validated health-related quality of life questionnaire consisting of physical and mental component scores.
Higher scores indicate better quality of life.
|
baseline
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Raina P, O'Donnell M, Rosenbaum P, Brehaut J, Walter SD, Russell D, Swinton M, Zhu B, Wood E. The health and well-being of caregivers of children with cerebral palsy. Pediatrics. 2005 Jun;115(6):e626-36. doi: 10.1542/peds.2004-1689.
- Adelman RD, Tmanova LL, Delgado D, Dion S, Lachs MS. Caregiver burden: a clinical review. JAMA. 2014 Mar 12;311(10):1052-60. doi: 10.1001/jama.2014.304.
- Isa SN, Ishak I, Ab Rahman A, Mohd Saat NZ, Che Din N, Lubis SH, Mohd Ismail MF. Health and quality of life among the caregivers of children with disabilities: A review of literature. Asian J Psychiatr. 2016 Oct;23:71-77. doi: 10.1016/j.ajp.2016.07.007. Epub 2016 Jul 16.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- UskudarU
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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