Clinical Trials Directory

Trials / Completed

CompletedNCT06014476

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

Status
Completed
Phase
Study type
Observational
Enrollment
256 (actual)
Sponsor
Hangzhou Normal University · Academic / Other
Sex
All
Age
17 Years – 81 Years
Healthy volunteers
Accepted

Summary

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.

Detailed description

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

Interventions

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

Timeline

Start date
2021-08-01
Primary completion
2022-10-31
Completion
2022-10-31
First posted
2023-08-28
Last updated
2023-08-28

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT06014476. Inclusion in this directory is not an endorsement.