NCT07680062

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 30, 2026

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 23, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 25, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 1, 2026

Completed
Last Updated

July 1, 2026

Status Verified

June 1, 2026

Enrollment Period

23 days

First QC Date

June 25, 2026

Last Update Submit

June 25, 2026

Conditions

Keywords

caregiversdisabled childrenpain measurementquality of lifeife

Outcome Measures

Primary Outcomes (3)

  • 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.

    baseline

  • 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.

    baseline

  • 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.

    baseline

Interventions

Not Applicable (N/A)

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Üsküdar University

Istanbul, Uskudar, 34662, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

MeSH Terms

Conditions

Caregiver BurdenPain

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehaviorNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2026

First Posted

July 1, 2026

Study Start

April 30, 2026

Primary Completion

May 23, 2026

Study Completion

May 23, 2026

Last Updated

July 1, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations