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Completed

NCT Number: NCT03494218

Reliability and Validity of the NCS (NCS-R)-Chinese Version

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

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Key information

Age range

19 year–53 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, 3100036, China

About this study

The assessment and early diagnosis of pain is of great importance for pain management and treatment in patients with disorders of consciousness. The Nociception Coma Scale (- Revised) is only applicable to assess pain of DOC patients in international clinical setting. The aim of this study was to translate the NCS 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. 'Faces, Legs, Activity, Cry, Consolability' (FLACC) was used to analysis concurrent validity by rater A.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • age ≥ 18 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

Nociception Coma Scale (NCS)

Diagnostic Test

Patients have been assessed with both the Nociception Coma Scale (NCS) and the FLACC.

Other names: the Face Legs Activity Cry and Consolability (FLACC)

Primary outcomes

  1. The level of perception of pain in DOC patients

    Time frame: Within 2 days

    This original NCS consists of four subscales to assess motor, verbal, visual and facial behavioral responses and each subscale score ranges from 0 to 3

Sponsors and collaborators

Lead sponsor

Hangzhou Normal University

Other

Registry information

Official study title

Reliability and Validity of the Nociception Coma Scale (-Revised)-Chinese Version

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 11, 2018
Registry last updated
Apr 11, 2018

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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