Validation of the Chinese Version of the SECONDs

Hangzhou Normal University

Status

Completed

Conditions

Vegetative State

Minimally Conscious State

Treatments

Diagnostic Test: Simplified Evaluation of CONsciousness Disorders (SECONDs)

Study type

Interventional

Funder types

Other

Identifiers

NCT04687553

2020W356354

Details and patient eligibility

About

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

Full 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.

Enrollment

120 patients

Sex

All

Ages

16 to 75 years old

Volunteers

No Healthy Volunteers

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).