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CompletedNCT07680062Updated Jul 1, 2026

Pain, Caregiver Burden, and Quality of Life in Mothers of Children With Disabilities

An observational study in Caregiver Burden, Pain and Quality of Life, sponsored by Uskudar University. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-01.

Sponsored by Uskudar University · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
29
Ages
18 Years to 65 Years
Sex
Female
01

Study summary

This study aims to investigate the relationships between pain intensity, caregiver burden, and quality of life in mothers of children with disabilities. Pain intensity, caregiver burden, and physical and mental quality of life will be evaluated using validated outcome measures. The study also aims to determine independent factors associated with quality of life in caregivers.

Read the 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.

02

Conditions studied

  • Caregiver Burden
  • Pain
  • Quality of Life

Keywords

  • caregivers
  • disabled children
  • pain measurement
  • quality of lifeife
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In context

Caregiver Burden

422 studies on the registry are indexed under Caregiver Burden; 151 are open to participants now.

This study's enrollment of 29 is below the median of 90 across 80 observational studies indexed under Caregiver Burden.

Browse Caregiver Burden studies →

Lead sponsor

Uskudar University is the lead sponsor of 164 studies on the registry; 35 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Sampling method
Non-probability sample

Study population

The study population consisted of mothers of children with disabilities who were providing long-term caregiving support. Participants were recruited voluntarily and included mothers of children diagnosed with conditions such as cerebral palsy, spina bifida, autism spectrum disorder, hydrocephalus, and other neurological or developmental disorders. Only mothers aged 18 years and older who were able to understand and complete the assessment forms were included in the study.

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

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
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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
29 participants (actual)
Patient registry
No

Interventions

  • OtherNot Applicable (N/A)

    Not Applicable (N/A)

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What researchers measure

Primary outcomes

  1. Zarit Caregiver Burden Scale

    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.

    Time frame: baseline

  2. Numeric Pain Scale (NPS)

    The Numeric Pain Scale is an 11-point scale ranging from 0 (no pain) to 10 (worst imaginable pain) used to assess pain intensity.

    Time frame: baseline

  3. Short Form-12 (SF-12)

    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.

    Time frame: baseline

07

Study locations

1 site
  • Üsküdar University
    Istanbul, Uskudar 34662, Turkey (Türkiye)
08

References and documents

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. PubMed 15930188 ↗
  • 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. PubMed 24618967 ↗
  • 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. PubMed 27969083 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07680062
Lead sponsor
Uskudar University
Responsible party
Sponsor
First posted
Jul 1, 2026
Start date
Apr 30, 2026
Primary completion
May 23, 2026
Completion
May 23, 2026
Last update
Jul 1, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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