Validation of the Chinese Version of the SECONDs

Not Applicable

Completed

• Conditions: Vegetative State; Minimally Conscious State
• Interventions: Diagnostic Test: Simplified Evaluation of CONsciousness Disorders (SECONDs)

• Registration Number: NCT04687553
• Lead Sponsor: Hangzhou Normal University

Brief Summary

The aim of this study was to translate the SECONDs from English into Chinese and determine the validity of this Chinese version

Detailed Description

The assessment is of great importance for the management and treatment in patients with disorders of consciousness. The Simplified Evaluation of CONsciousness Disorders is a useful tool to assess consciousness of DOC patients in bedside. The aim of this study was to translate the SECONDs from English into Chinese and determine the validity of this Chinese version. To test internal reliability and inter-rater reliability, both rater A and rater B assess the perception of pain on day 1; and to obtain test-retest reliability, rater A assessed all patients repeatedly on day 2.

Study Timeline

• Study Start: 2020-11-10
• Study First Submitted: 2020-12-08
• Study First Submitted QC: 2020-12-24
• Study First Posted: 2020-12-29
• Primary Completion: 2021-07-01
• Study Completion: 2021-07-01
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-07
• Last Update Posted: 2022-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• age ≥ 16 years old;
• no administration of neuromuscular blockers or sedation within the 24 hours of enrolment;
• the presence of periods of eye opening (indicating wakefulness and rest cycles);
• a diagnosis of VS or MCS, based on more than 4 times behavioral assessment performed using the Coma Recovery Scale-Revised within 2 weeks.

Exclusion Criteria

• Coma;
• documented history of prior brain injury;
• psychiatric or neurologic illness;
• neuromuscular blocking agents or sedative drugs administered within the prior 24 hours;
• no documented history of a prior coma, critical illness or unstable medical condition;
• upper limb contusions, fractures (based on the imaging examination) or flaccid paralysis (by using noxious stimuli to upper limbs, motor sub-scale scores <1).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients with minimally conscious state	Simplified Evaluation of CONsciousness Disorders (SECONDs)	Patients with minimally conscious state were assessed by the SECONDs and CRS-R for two days.
Patients with vegetative state	Simplified Evaluation of CONsciousness Disorders (SECONDs)	Patients with vegetative state were assessed by the SECONDs and CRS-R for two days.

Primary Outcome Measures

Name	Time	Method
The level of consciousness in DOC patients	Within 2 days	All patients were classified as the MCS and VS by the Coma recovery scale-revised

Trial Locations

Locations (1)

International Vegetative State and Consciousness Science Institute, Hangzhou Normal University; 🇨🇳 Hangzhou, Zhejiang, China