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Validation of the Chinese Version of the SECONDs

NCT04687553 — Not applicable, Completed, 120 participants, Hangzhou Normal University

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

RegistryNCT04687553
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: double, diagnostic
Enrollment120 (Actual)
SponsorHangzhou Normal University (Other)
ConditionsMinimally Conscious State, Vegetative State
InterventionsSimplified Evaluation of CONsciousness Disorders (SECONDs) (Diagnostic test)
Datesstart 2020-11-10, primary completion 2021-07-01, completion 2021-07-01, first posted 2020-12-29, last updated 2022-07-08
Locations1 site in China

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-Summary

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

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Patients with vegetative stateExperimentalDiagnostic 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 stateExperimentalDiagnostic Test: Simplified Evaluation of CONsciousness Disorders (SECONDs)Patients with minimally conscious state were assessed by the SECONDs and CRS-R for two days.
  • Simplified Evaluation of CONsciousness Disorders (SECONDs) (Diagnostic test): All patients were assessed by the Simplified Evaluation of CONsciousness Disorders (SECONDs)

+Outcome measures

Primary outcomes

  • 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

+Eligibility

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).

+Locations (1)

FacilityCityCountryStatus
International Vegetative State and Consciousness Science Institute, Hangzhou Normal UniversityHangzhou, ZhejiangChina

+Investigators

  • Haibo Di, Pro., Study chair, International Vegetative State and Consciousness Science Institute, Hangzhou Normal University

My Notes