Psychological Symptoms and Burden in Caregivers of Patients With Disorders of Consciousness

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

256 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-01

Study Completion Date

2022-10-31

Brief Summary

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Caregivers of patients with disorders of consciousness are highly prone to developing mental health issues. The aim of this study is to investigate the psychological symptoms and care burden of caregivers of patients with disorders of consciousness (DoC), and to examine which characteristics of patients were burden predictors to caregivers.

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Detailed Description

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This is a multi-center cross-sectional study in China, from August 2021 to October 2022. Patients were assessed by Coma Recovery Scale-Revised (CRS-R), and caregivers' anxiety, depression, and burden were assessed by State-Trait Anxiety Inventory Form Y (STAI), Beck Depression Inventory-II (BDI- II), and Zarit Caregiver Burden scale (ZBI). The comparison with patients' age and caregivers' age-matched subjects who were randomly selected and without DoC; intra-group comparison of caregivers for DoC was conducted. Descriptive statistics were used to illustrate the socio-demographics. One-sample t-test, independent sample t-test, one-way ANOVA, Mann-Whitney U test, and Kruskal-Wallis test were executed to detect the difference between groups due to the distribution of each variable.

Conditions

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Psychological Distress Anxiety Depression Burden, Caregiver Disorders of Consciousness

Study Design

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Observational Model Type

FAMILY_BASED

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Experimental Group

Caregivers of patients with disorders of consciousness, including Coma, Unresponsive Wakefulness Syndrome (UWS), and Minimally Consciousness State (MCS). And caregivers of patients emerge from the minimally conscious state (EMCS)

questionnaires

Intervention Type OTHER

Sent questionnaires to caregivers and used CRS-R to assess patients with DoC

Control group

caregivers of patients with other disease

questionnaires

Intervention Type OTHER

Sent questionnaires to caregivers and used CRS-R to assess patients with DoC

Interventions

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questionnaires

Sent questionnaires to caregivers and used CRS-R to assess patients with DoC

Intervention Type OTHER

Other Intervention Names

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Coma Recovery Scale-Revised (CRS-R)

Eligibility Criteria

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Inclusion Criteria

\- (1) Family caregivers without neurological, mental health, or learning disability history.

(2) Family caregiver with consciousness and capability of independently completing questionnaires.