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NCT Number: NCT04687553

Validation of the Chinese Version of the SECONDs

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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Key information

Age range

16 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

International Vegetative State and Consciousness Science Institute, Hangzhou Normal University

Hangzhou, Zhejiang, 310036, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Simplified Evaluation of CONsciousness Disorders (SECONDs)

Diagnostic Test

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

Primary outcomes

  1. The level of consciousness in DOC patients

    Time frame: Within 2 days

    All patients were classified as the MCS and VS by the Coma recovery scale-revised

Sponsors and collaborators

Lead sponsor

Hangzhou Normal University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 29, 2020
Registry last updated
Jul 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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