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

H

Hangzhou Normal University

Status

Completed

Conditions

Vegetative State
Minimally Conscious State

Treatments

Diagnostic Test: Nociception Coma Scale (NCS)

Study type

Interventional

Funder types

Other

Identifiers

NCT03494218
2017R423055

Details and patient eligibility

About

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

Full description

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.

Enrollment

62 patients

Sex

All

Ages

19 to 53 years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

62 participants in 2 patient groups

vegetative state
Experimental group
Description:
patients with vegetative state lack awareness of self and environment even in the presence for eye-opening and sleep-wake cycles using CRS-R. The nailbed pressure was applied for 5 seconds and ended as soon as the behavioral response were captured. The raters recorded patients' behavioral responses using Nociception Coma Scale (NCS) during 10 seconds after each noxious stimulus.
Treatment:
Diagnostic Test: Nociception Coma Scale (NCS)
minimally conscious state
Experimental group
Description:
Patients with minimally conscious state display inconsistent, but reproducible and discernible signs of awareness using CRS-R. The nailbed pressure was applied for 5 seconds and ended as soon as the behavioral response were captured. The raters recorded patients' behavioral responses using Nociception Coma Scale (NCS) during 10 seconds after each noxious stimulus.
Treatment:
Diagnostic Test: Nociception Coma Scale (NCS)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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