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

Not Applicable

Completed

• Conditions: Minimally Conscious State; Vegetative State
• Interventions: Diagnostic Test: Nociception Coma Scale (NCS)

• Registration Number: NCT03494218
• Lead Sponsor: Hangzhou Normal University

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.

Study Timeline

• Study Start: 2017-10-28
• Primary Completion: 2018-02-02
• Study Completion: 2018-03-01
• Status Verified: 2018-04
• Study First Submitted: 2018-04-03
• Study First Submitted QC: 2018-04-09
• Last Update Submitted: 2018-04-09
• Study First Posted: 2018-04-11
• Last Update Posted: 2018-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
minimally conscious state	Nociception Coma Scale (NCS)	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.
vegetative state	Nociception Coma Scale (NCS)	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.

Primary Outcome Measures

Name	Time	Method
The level of perception of pain in DOC patients	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

Trial Locations

Locations (1)

International Vegetative State and Consciousness Science Institute, Hangzhou Normal University; 🇨🇳 Hangzhou, Zhejiang, China