Chinese Validation of the Simplified Evaluation of CONsciousness Disorders（SECONDs）

Hangzhou Normal University

Status: Completed

Conditions: Unconsciousness; Vegetative State; Central Nervous System Diseases; Brain Diseases

Treatments: Diagnostic Test: Simplified Evaluation of CONsciousness Disorders (SECONDs)

Study type: Interventional

Funder types: Other

Identifiers

NCT05496985

YCYY-20211021-003

Details and patient eligibility

About

The aim of this study was to translate the SECONDs from French into Chinese and assess the validity and reliability of the Chinese version of the SECONDs .

Full description

To promote accurate assessments of DoC patients and the development of clinical research on DoC in China, we here propose and validate a version of the SECONDs translated into Mandarin Chinese. Hence, this study aims to assess the concurrent validity (compared with the CRS-R which has already been translated and validated in Mandarin), intra-rater reliability, and inter-rater reliability of the Chinese version of the SECONDs

Enrollment: 49 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Acute (longer than 14 days, less than 28 days) or prolonged DoC (following severe acquired brain injury, longer than 28 days);
• Age: 18-85 years old;
• No history of other neurological or psychiatric deficits;
• Ability to speak Chinese fluently;
• Medical stability (e.g., absence of mechanical ventilation, sedation, infection)

Exclusion criteria

• None

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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49 participants in 4 patient groups

Patients in coma

Experimental group

Description:

Patients in coma were assessed by the SECONDs and CRS-R for five days.

Treatment:

Diagnostic Test: Simplified Evaluation of CONsciousness Disorders (SECONDs)

Patients in unresponsive wakefulness syndrome

Experimental group

Description:

Patients in unresponsive wakefulness syndrome were assessed by the SECONDs and CRS-R for five days.

Treatment:

Diagnostic Test: Simplified Evaluation of CONsciousness Disorders (SECONDs)

Patients in minimally conscious state

Experimental group

Description:

Patients in minimally conscious state were assessed by the SECONDs and CRS-R for five days.

Treatment:

Diagnostic Test: Simplified Evaluation of CONsciousness Disorders (SECONDs)

Patients in emerge from the minimally conscious state

Experimental group

Description:

Patients in emerge from the minimally conscious state were assessed by the SECONDs and CRS-R for five days.

Treatment:

Diagnostic Test: Simplified Evaluation of CONsciousness Disorders (SECONDs)