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Clinical Trials/NCT06014476
NCT06014476
Completed
Not Applicable

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

Hangzhou Normal University1 site in 1 country256 target enrollmentAugust 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Psychological Distress
Sponsor
Hangzhou Normal University
Enrollment
256
Locations
1
Primary Endpoint
The prevalence of anxiety in caregivers of patients with disorders of consciousness.
Status
Completed
Last Updated
2 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
August 1, 2021
End Date
October 31, 2022
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Hangzhou Normal University
Responsible Party
Principal Investigator
Principal Investigator

Haibo Di

Principal Investigator

Hangzhou Normal University

Eligibility Criteria

Inclusion Criteria

  • (1) Family caregivers without neurological, mental health, or learning disability history.
  • (2) Family caregiver with consciousness and capability of independently completing questionnaires.
  • Exclusion criteria:
  • Caregivers unwilling to participate
  • Not the dominant caregivers

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

The prevalence of anxiety in caregivers of patients with disorders of consciousness.

Time Frame: Within 1 days

We use the State-Trait Anxiety Inventory Form Y (STAI-Y) to assess the prevalence and severity degree of anxiety for caregivers of patients with disorders of consciousness (DoC) STAI was a self-rating scale, consisting of 40 items and divided into two subscales: 1) state anxiety (S-AI) scale includes questions 1-20, state anxiety shows the transitory unpleasant. 2) trait anxiety (T-AI) scale includes questions 21-40, trait anxiety tends to the personality trait. The cumulative score values of state anxiety and trait anxiety scales were calculated respectively, the minimum to maximum value was from 20 to 80, the higher scores mean a worse outcome.

The prevalence and severity degree of burden in caregivers of patients with disorders of consciousness.

Time Frame: Within 1 days

We use the Zarit Caregiver Burden Scale (ZBI) to assess the prevalence and severity degree of burden for caregivers of patients with disorders of consciousness (DoC) ZBI total score: 0-20 indicates no burden, 21-40 mild burden, 41-60 moderate burden, and 61-88 severe burden.

The predictors of depression in caregivers of patients with disorders of consciousness.

Time Frame: Within 1 days

We choose a series of questionnaires to figure out: (1) What are the characteristics of patients and caregivers were caregivers' depression predictors? The questionnaires include social-demographic questionnaires (including personal information of patients and caregivers e.g., age, gender, etiology, diagnosis, and so on, to record their basic information), and the Beck Depression Inventory-II (BDI-II). We used the Independent-sample T-test, one-way ANOVA, Mann-Whitney U test, Kruskal-Wallis test, and Pearson Correlation to calculate the correlation between the characteristics of patients and caregivers and caregivers' depression.

The predictors of burden in caregivers of patients with disorders of consciousness.

Time Frame: Within 1 days

We choose a series of questionnaires to figure out: (1) What are the characteristics of patients and caregivers were caregivers' burden predictors? The questionnaires include social-demographic questionnaires (including personal information of patients and caregivers e.g., age, gender, etiology, diagnosis, and so on, to record their basic information), and the Zarit Caregiver Burden Scale (ZBI). We used the Independent-sample T-test, one-way ANOVA, Mann-Whitney U test, Kruskal-Wallis test, and Pearson Correlation to calculate the correlation between the characteristics of patients and caregivers and caregivers' burden.

The predictors of anxiety in caregivers of patients with disorders of consciousness.

Time Frame: Within 1 days

We choose a series of questionnaires to figure out: what are the characteristics of patients and caregivers were caregivers' anxiety predictors? The questionnaires include social-demographic questionnaires (including personal information of patients and caregivers e.g., age, gender, etiology, diagnosis, and so on, to record their basic information) and the State-Trait Anxiety Inventory Form Y (STAI-Y). We used the Independent-sample T-test, one-way ANOVA, Mann-Whitney U test, Kruskal-Wallis test, and Pearson Correlation to calculate the correlation between the characteristics of patients and caregivers and caregivers' anxiety.

The prevalence and severity degree of depression in caregivers of patients with disorders of consciousness.

Time Frame: Within 1 days

We use the Beck Depression Inventory-II (BDI-II) to assess the prevalence and severity degree of depression for caregivers of patients with disorders of consciousness (DoC) BDI total score: 0-13 as no depression, 14-19 as mild depression, 20-28 as medium depression, and 29-63 as severe depression.

Secondary Outcomes

  • The relationship between patient diagnoses and caregivers' burden(Within 1 days)
  • The diagnoses of patients with disorders of consciousness (DoC)(Within 10 days)
  • The relationship between patient diagnoses and caregivers' anxiety(Within 1 days)
  • The relationship between patient diagnoses and caregivers' depression(Within 1 days)

Study Sites (1)

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