Caregiver BurdenCaregiverNCT07131930
A Study on the Relationship Between Caregiver Burden, Resilience, and Sleep Quality in Individuals Providing Care for Bedridden Patients
An observational study of Caregiver Burden, run by UĞUR UZUN at 1 site in Turkey (Türkiye).
Trial summary
This observational study aims to examine the relationship between caregiver burden, psychological resilience, and sleep quality in individuals providing care for bedridden patients, particularly in the context of palliative care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Caregiver Burden
- What is being tested?
- Caregiver Burden, Psychological Resilience, Sleep Quality
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2025to 1 Jun 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Informal caregivers of bedridden patients who are currently hospitalized in the palliative care unit of a tertiary care hospital.
Who may be able to join
- Individuals aged 18 years or older
- Informal caregivers (family members or close contacts) providing daily care for bedridden patients hospitalized in the palliative care unit
- Ability to provide informed consent
- Willingness to voluntarily participate in the study
Who cannot join
- Individuals under the age of 18
- Individuals with cognitive impairments that prevent them from completing the questionnaires
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relationship Between Caregiver Burden, Resilience Level and Sleep Quality in Individuals Providing Care for Bedridden Patients
This observational study aims to examine the relationship between caregiver burden, psychological resilience, and sleep quality in individuals providing care for bedridden patients, particularly in the context of palliative care. In many cases, the care of bedridden patients in hospitals and at home is undertaken by family members. The caregiving process can be physically, emotionally, and financially demanding. Caregivers often face challenges such as irregular eating habits, chronic fatigue, body pain, difficulty concentrating, restlessness, insomnia, and even increased use of alcohol or medication. These burdens can also negatively impact their social relationships, work performance, and financial stability.
As caregiver burden increases, caregivers are more likely to experience sleep disorders, anxiety, depression, stress, and burnout. These issues not only affect the caregiver's quality of life but also reduce the quality of care provided to the patient. It is therefore crucial to assess the psychosocial needs of caregivers and to understand the factors that influence their ability to cope with caregiving demands.
Psychological resilience-defined as the ability to adapt to stress and recover from adversity-is believed to play a key role in coping with caregiver stress, though its relationship with caregiver burden remains unclear. This study will evaluate caregiver burden, sleep quality, and psychological resilience using validated questionnaires. Participants will be caregivers of patients currently hospitalized in our palliative care unit. After obtaining ethical approval, individuals who consent to participate will complete the questionnaires. The results will help inform future support strategies aimed at improving caregiver well-being and patient care quality.
Read the detailed description
This observational study is conducted to evaluate the relationship between caregiver burden, psychological resilience, and sleep quality among individuals providing care for bedridden patients in a hospital-based palliative care unit.
The study population will consist of caregivers (aged 18 and older) of patients hospitalized in the palliative care unit. After obtaining ethics committee approval, voluntary participants who provide informed consent will be asked to complete a series of validated self-report questionnaires, including:
- Zarit Burden Interview (ZBI) to assess caregiver burden
- Pittsburgh Sleep Quality Index (PSQI) to measure sleep quality
- Resilience Scale to assess psychological resilience The sample size was estimated based on similar studies in the literature, aiming for a minimum of 100 participants to achieve sufficient statistical power. Statistical analysis will be performed using SPSS software (v27). Descriptive statistics, correlation analysis, and multiple linear regression models will be used to examine the relationships among caregiver burden, sleep quality, and resilience. A p-value of <0.05 will be considered statistically significant.
The data will be collected through face-to-face interviews or self-administered paper questionnaires. Participants' sociodemographic characteristics will also be recorded. The study does not involve any interventions or experimental procedures.
Findings from this study may contribute to the development of targeted psychosocial interventions to support caregivers of functionally dependent patients and improve the overall quality of care.
- Conditions
- Caregiver Burden
- Being tested
- Caregiver Burden, Psychological Resilience, Sleep Quality
- Keywords
- Caregiver Burden, Resilience, Sleep Quality, Palliative Care
- Medical subject headings
- Caregiver Burden, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caregiver Burden, Psychological Resilience, Sleep QualityOther
Informal caregivers who provide daily care for bedridden patients are evaluated in this study. The exposure involves physical, emotional, and financial caregiving responsibilities such as assistance with feeding, mobility, and emotional support. The impact of caregiving on sleep quality and psychological resilience is assessed using validated questionnaires (Zarit Burden Interview, Pittsburgh Sleep Quality Index, Resilience Scale).
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between Zarit Burden Interview (ZBI, 19-item scale) and Adult Resilience Scale (ARS, 33-item scale)
Measured: at enrollment
Secondary outcomes (1)
Correlation between Zarit Burden Interview (ZBI, 19-item scale) and Pittsburgh Sleep Quality Index (PSQI, 19-item scale)
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start1 Mar 2025
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- UĞUR UZUN
- Sponsor type
- University, hospital or other
- Collaborators
- Tepecik Training and Research Hospital
- Responsible party
- Sponsor-investigator, UĞUR UZUN, Tepecik Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07131930
- Sponsor's protocol ID
- 2023/09-20
- Other IDs
- 2023/09-20
- Acronym
- Caregiver
- Status last verified
- Jul 2025
- First submitted
- 4 Aug 2025
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Caregiver Burden, Resilience Level and Sleep Quality in Individuals Providing Care for Bedridden Patients
- ClinicalTrials.gov ID
- NCT07131930
- Acronym / sponsor ID
- Caregiver / 2023/09-20
- Conditions
- Caregiver Burden
- Keywords
- Caregiver Burden, Resilience, Sleep Quality, Palliative Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- UĞUR UZUNUniversity, hospital or other
- Collaborators
- Tepecik Training and Research Hospital
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 20 Aug 2025 (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 observational study aims to examine the relationship between caregiver burden, psychological resilience, and sleep quality in individuals providing care for bedridden patients, particularly in the context of palliative care. In many cases, the care of bedridden patients in hospitals and at home is undertaken by family members. The caregiving process can be physically, emotionally, and financially demanding. Caregivers often face challenges such as irregular eating habits, chronic fatigue, body pain, difficulty concentrating, restlessness, insomnia, and even increased use of alcohol or medication. These burdens can also negatively impact their social relationships, work performance, and financial stability.
As caregiver burden increases, caregivers are more likely to experience sleep disorders, anxiety, depression, stress, and burnout. These issues not only affect the caregiver's quality of life but also reduce the quality of care provided to the patient. It is therefore crucial to assess the psychosocial needs of caregivers and to understand the factors that influence their ability to cope with caregiving demands.
Psychological resilience-defined as the ability to adapt to stress and recover from adversity-is believed to play a key role in coping with caregiver stress, though its relationship with caregiver burden remains unclear. This study will evaluate caregiver burden, sleep quality, and psychological resilience using validated questionnaires. Participants will be caregivers of patients currently hospitalized in our palliative care unit. After obtaining ethical approval, individuals who consent to participate will complete the questionnaires. The results will help inform future support strategies aimed at improving caregiver well-being and patient care quality.
Detailed description
This observational study is conducted to evaluate the relationship between caregiver burden, psychological resilience, and sleep quality among individuals providing care for bedridden patients in a hospital-based palliative care unit.
The study population will consist of caregivers (aged 18 and older) of patients hospitalized in the palliative care unit. After obtaining ethics committee approval, voluntary participants who provide informed consent will be asked to complete a series of validated self-report questionnaires, including:
- Zarit Burden Interview (ZBI) to assess caregiver burden
- Pittsburgh Sleep Quality Index (PSQI) to measure sleep quality
- Resilience Scale to assess psychological resilience The sample size was estimated based on similar studies in the literature, aiming for a minimum of 100 participants to achieve sufficient statistical power. Statistical analysis will be performed using SPSS software (v27). Descriptive statistics, correlation analysis, and multiple linear regression models will be used to examine the relationships among caregiver burden, sleep quality, and resilience. A p-value of <0.05 will be considered statistically significant.
The data will be collected through face-to-face interviews or self-administered paper questionnaires. Participants' sociodemographic characteristics will also be recorded. The study does not involve any interventions or experimental procedures.
Findings from this study may contribute to the development of targeted psychosocial interventions to support caregivers of functionally dependent patients and improve the overall quality of care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Informal caregivers of bedridden patients who are currently hospitalized in the palliative care unit of a tertiary care hospital.
Key inclusion criteria (4 listed)
- Individuals aged 18 years or older
- Informal caregivers (family members or close contacts) providing daily care for bedridden patients hospitalized in the palliative care unit
- Ability to provide informed consent
- Willingness to voluntarily participate in the study
Key exclusion criteria (2 listed)
- Individuals under the age of 18
- Individuals with cognitive impairments that prevent them from completing the questionnaires
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 |
|---|---|---|
| Caregiver Burden, Psychological Resilience, Sleep QualityInformal caregivers who provide daily care for bedridden patients are evaluated in this study. The exposure involves physical, emotional, and financial caregiving responsibilities such as assistance with feeding, mobility, and emotional support. The impact of caregiving on sleep quality and psychological resilience is assessed using validated questionnaires (Zarit Burden Interview, Pittsburgh Sleep Quality Index, Resilience Scale). | Other | – |
Primary outcome
Correlation between Zarit Burden Interview (ZBI, 19-item scale) and Adult Resilience Scale (ARS, 33-item scale)
Time frame: at enrollment
1 secondary outcome
Correlation between Zarit Burden Interview (ZBI, 19-item scale) and Pittsburgh Sleep Quality Index (PSQI, 19-item scale)
Time frame: At enrollment
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 20 Aug 2025.
- 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, run by UĞUR UZUN 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 4 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 20 Aug 2025. 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?
Correlation between Zarit Burden Interview (ZBI, 19-item scale) and Adult Resilience Scale (ARS, 33-item scale) (time frame: at enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Aug 2025.