An observational study in Psychological Distress, Anxiety Depression and Burden, Caregiver, sponsored by Hangzhou Normal University. Completed at 1 site in China. Open to participants aged 17 Years to 81 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-28.
Sponsored by Hangzhou Normal University · Observational
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.
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.
500 studies on the registry are indexed under Caregiver Burden; 164 are open to participants now.
This study's enrollment of 256 is above the median of 100 across 80 observational studies indexed under Caregiver Burden.
Browse Caregiver Burden studies →Hangzhou Normal University is the lead sponsor of 22 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Caregivers of patients with DoC and other diseases
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
(2) Family caregiver with consciousness and capability of independently completing questionnaires.
Exclusion criteria:
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)
Other: questionnaires
caregivers of patients with other disease
Other: questionnaires
Sent questionnaires to caregivers and used CRS-R to assess patients with DoC
Also known as: Coma Recovery Scale-Revised (CRS-R)
The prevalence of anxiety in caregivers of patients with disorders of consciousness.
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.
Time frame: Within 1 days
The prevalence and severity degree of depression in caregivers of patients with disorders of consciousness.
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.
Time frame: Within 1 days
The prevalence and severity degree of burden in caregivers of patients with disorders of consciousness.
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.
Time frame: Within 1 days
The predictors of anxiety in caregivers of patients with disorders of consciousness.
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.
Time frame: Within 1 days
The predictors of depression in caregivers of patients with disorders of consciousness.
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.
Time frame: Within 1 days
The predictors of burden in caregivers of patients with disorders of consciousness.
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.
Time frame: Within 1 days
The diagnoses of patients with disorders of consciousness (DoC)
The DoC patients were evaluated 3-5 times Coma Recovery Scale-Revised (CRS-R) within 10 days after questionnaire distribution to determine their current state of consciousness.
Time frame: Within 10 days
The relationship between patient diagnoses and caregivers' anxiety
We compare patient diagnoses (assessed by Coma Recovery Scale-Revised (CRS-R) ) and caregivers' anxiety (assessed by the State-Trait Anxiety Inventory Form Y (STAI-Y) ) We used the one-way ANOVA to calculate the relationship between patient diagnoses and caregivers' anxiety.
Time frame: Within 1 days
The relationship between patient diagnoses and caregivers' depression
We compare patient diagnoses (assessed by Coma Recovery Scale-Revised (CRS-R) ) and caregivers' depression (assessed by the Beck Depression Inventory-II (BDI-II) ) We used the one-way ANOVA to calculate the relationship between patient diagnoses and caregivers' depression.
Time frame: Within 1 days
The relationship between patient diagnoses and caregivers' burden
We compare patient diagnoses (assessed by Coma Recovery Scale-Revised (CRS-R) ) and caregivers' depression (assessed by the Zarit Caregiver Burden Scale (ZBI) ) We used the one-way ANOVA to calculate the relationship between patient diagnoses and caregivers' burden.
Time frame: Within 1 days
Plan to share: No
No publications or documents are linked to this record.
Ran from Aug 2021 to primary completion in Oct 2022, 14 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hangzhou Normal University