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

Minimally Conscious State Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03494218
• Other study ID #: 2017R423055
• Status: Completed
• Phase: N/A
• First received: April 3, 2018
• Last updated: April 9, 2018
• Start date: October 28, 2017
• Est. completion date: March 1, 2018

Study information

• Verified date: April 2018
• Source: Hangzhou Normal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: March 1, 2018
• Est. primary completion date: February 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 53 Years

Eligibility

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).

Related Conditions & MeSH terms

• Minimally Conscious State
• Persistent Vegetative State
• Vegetative State

Intervention

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

Locations

Country	Name	City	State
China	International Vegetative State and Consciousness Science Institute, Hangzhou Normal University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Hangzhou Normal University

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The level of perception of pain in DOC patients	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	Within 2 days