Clinical trial NCT03494218: Reliability and Validity of the NCS (NCS-R)-Chinese Version
Official title: Reliability and Validity of the Nociception Coma Scale (-Revised)-Chinese Version
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Minimally Conscious State
Vegetative State
Keywords: disorders of consciousness
vegetative state
minimally conscious state
consciousness
pain assessment
nociception test
Lead sponsor: Hangzhou Normal University
Sponsor class: OTHER
First posted: 2018-04-11
Enrollment: 62
Sex: ALL
Minimum age (years): 19
Maximum age (years): 53
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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)
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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).

Primary outcomes:
measure: The level of perception of pain in DOC patients
timeFrame: Within 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: International Vegetative State and Consciousness Science Institute, Hangzhou Normal University
state: Zhejiang
Study officials:
affiliation: International Vegetative State and Consciousness Science Institute, Hangzhou Normal University
name: Haibo Di, Pro
role: STUDY_CHAIR
References:
citation: Chatelle C, Majerus S, Whyte J, Laureys S, Schnakers C. A sensitive scale to assess nociceptive pain in patients with disorders of consciousness. J Neurol Neurosurg Psychiatry. 2012 Dec;83(12):1233-7. doi: 10.1136/jnnp-2012-302987. Epub 2012 Aug 20.