Validation of the Chinese Version of the Simplified Evaluation of CONsciousness Disorders (SECONDs)
| Registry | NCT04687553 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, diagnostic |
| Enrollment | 120 (Actual) |
| Sponsor | Hangzhou Normal University (Other) |
| Conditions | Minimally Conscious State, Vegetative State |
| Interventions | Simplified Evaluation of CONsciousness Disorders (SECONDs) (Diagnostic test) |
| Dates | start 2020-11-10, primary completion 2021-07-01, completion 2021-07-01, first posted 2020-12-29, last updated 2022-07-08 |
| Locations | 1 site in China |
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All trials for Minimally Conscious State All trials for Vegetative State All trials of Simplified Evaluation of CONsciousness Disorders (SECONDs)
The aim of this study was to translate the SECONDs from English into Chinese and determine the validity of this Chinese version
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Patients with vegetative state | Experimental | Diagnostic Test: Simplified Evaluation of CONsciousness Disorders (SECONDs) | Patients with vegetative state were assessed by the SECONDs and CRS-R for two days. |
| Patients with minimally conscious state | Experimental | Diagnostic Test: Simplified Evaluation of CONsciousness Disorders (SECONDs) | Patients with minimally conscious state were assessed by the SECONDs and CRS-R for two days. |
Sex: All, ages: 16 Years to 75 Years
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).
| Facility | City | Country | Status |
|---|---|---|---|
| International Vegetative State and Consciousness Science Institute, Hangzhou Normal University | Hangzhou, Zhejiang | China |