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

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

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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)