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NCT Number: NCT07131930

A Study on the Relationship Between Caregiver Burden, Resilience, 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.

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Key information

Conditions

Caregiver Burden Behavior Behavioral Symptoms Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Stress, Psychological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tepecik Training and Research Hospital

Izmir, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Caregiver Burden, Psychological Resilience, Sleep Quality

Other

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).

Primary outcomes

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

    Time frame: at enrollment

Secondary outcomes

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

    Time frame: At enrollment

Sponsors and collaborators

Lead sponsor

UĞUR UZUN

Other

Collaborators

  • Tepecik Training and Research Hospital

Registry information

Official study title

The Relationship Between Caregiver Burden, Resilience Level and Sleep Quality in Individuals Providing Care for Bedridden Patients

Acronym: Caregiver

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 20, 2025
Registry last updated
Aug 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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