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Validation of the Chinese Version of the SECONDs

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04687553
Enrollment
120
Registered
2020-12-29
Start date
2020-11-10
Completion date
2021-07-01
Last updated
2022-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Minimally Conscious State, Vegetative State

Keywords

disorders of consciousness, vegetative state, minimally conscious state, consciousness

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.

Interventions

All patients were assessed by the Simplified Evaluation of CONsciousness Disorders (SECONDs)

Sponsors

Hangzhou Normal University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)

Intervention model description

The order of the administration was randomly selected. All patients' total scores assessed by rater A were recorded to test the internal consistency of SECONDs (A1). Meanwhile, to assess the concurrent validity, the scores of the CRS-R were recorded together with SECONDs by rater A on day 1. In order to analyze the test-retest reliability, rater A complete the second evaluation of SECONDs on day 2 (A2).

Eligibility

Sex/Gender
ALL
Age
16 Years to 75 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
The level of consciousness in DOC patientsWithin 2 daysAll patients were classified as the MCS and VS by the Coma recovery scale-revised

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026