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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03494218
Enrollment
62
Registered
2018-04-11
Start date
2017-10-28
Completion date
2018-03-01
Last updated
2018-04-11

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, pain assessment, nociception test

Brief summary

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

Detailed 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.

Interventions

DIAGNOSTIC_TESTNociception Coma Scale (NCS)

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

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 NCS-R (A1). Meanwhile, to assess the concurrent validity, the scores of the FLACC were recorded together with NCS-R by rater A on day 1. In order to analyze the test-retest reliability, rater A complete the second evaluation of NCS-R on day 2 (A2)

Eligibility

Sex/Gender
ALL
Age
19 Years to 53 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
The level of perception of pain in DOC patientsWithin 2 daysThis original NCS consists of four subscales to assess motor, verbal, visual and facial behavioral responses and each subscale score ranges from 0 to 3

Countries

China

Outcome results

None listed

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