Caregiver BurdenNCT07680062
Pain, Caregiver Burden, and Quality of Life in Mothers of Children With Disabilities
An observational study of Caregiver Burden and Pain, run by Uskudar University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Caregiver Burden, Pain, Quality of Life
- What is being tested?
- Not Applicable (N/A)
- How many people
- 29 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Apr 2026to 23 May 2026
- 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 18 to 65 years
- Women only
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relationship Between Pain Intensity, Caregiver Burden, and Quality of Life in Mothers of Children With Disabilities: A Cross-Sectional Study
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.
- Conditions
- Caregiver Burden, Pain, Quality of Life
- Being tested
- Not Applicable (N/A)
- Keywords
- caregivers, disabled children, pain measurement, quality of lifeife
- Medical subject headings
- Caregiver Burden, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not Applicable (N/A)Other
Not Applicable (N/A)
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start30 Apr 2026
- Primary completion23 May 2026
- Study completion23 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Caregiver BurdenStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07680062
- Sponsor's protocol ID
- UskudarU
- Status last verified
- Jun 2026
- First submitted
- 25 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 15930188Adelman 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 24618967Isa 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
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Pain Intensity, Caregiver Burden, and Quality of Life in Mothers of Children With Disabilities: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07680062
- Acronym / sponsor ID
- UskudarU
- Conditions
- Caregiver Burden, Pain, Quality of Life
- Keywords
- caregivers, disabled children, pain measurement, quality of lifeife
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- 30 Apr 2026 (actual)
- Primary completion
- 23 May 2026 (actual)
- Study completion
- 23 May 2026 (actual)
- First posted
- 1 Jul 2026 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| Not Applicable (N/A)Not Applicable (N/A) | Other | – |
Primary outcome
Zarit Caregiver Burden Scale
Time frame: baseline
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.
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.
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.
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 1 Jul 2026.
- Results publication: PubMed 15930188Raina 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.
- Results publication: PubMed 24618967Adelman 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.
- Results publication: PubMed 27969083Isa 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.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Caregiver Burden and Pain, run by Uskudar University at 1 site in Turkey (Türkiye).
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 2 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 1 Jul 2026. 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 Turkey (Türkiye). 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?
Zarit Caregiver Burden Scale (time frame: baseline). The study lists 3 primary outcomes in all. 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 NCT07680062, which also lists 3 linked publications.
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 1 Jul 2026.