NCT07131930

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2025

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 20, 2025

Completed
Last Updated

August 20, 2025

Status Verified

July 1, 2025

Enrollment Period

3 months

First QC Date

August 4, 2025

Last Update Submit

August 17, 2025

Conditions

Keywords

Caregiver BurdenResilienceSleep QualityPalliative Care

Outcome Measures

Primary Outcomes (1)

  • Correlation between Zarit Burden Interview (ZBI, 19-item scale) and Adult Resilience Scale (ARS, 33-item scale)

    at enrollment

Secondary Outcomes (1)

  • Correlation between Zarit Burden Interview (ZBI, 19-item scale) and Pittsburgh Sleep Quality Index (PSQI, 19-item scale)

    At enrollment

Interventions

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).

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Informal caregivers of bedridden patients who are currently hospitalized in the palliative care unit of a tertiary care hospital.

You may qualify if:

  • 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

You may not qualify if:

  • Individuals under the age of 18
  • Individuals with cognitive impairments that prevent them from completing the questionnaires

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tepecik Training and Research Hospital

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Caregiver BurdenSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehaviorSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Specialist in Anesthesiology and Reanimation

Study Record Dates

First Submitted

August 4, 2025

First Posted

August 20, 2025

Study Start

March 1, 2025

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

August 20, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations