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

NCT ID: NCT03494218

Last Updated: 2018-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-28
• Study Completion Date: 2018-03-01

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.

Conditions

Minimally Conscious State; Vegetative State

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

vegetative state

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.

Group Type: EXPERIMENTAL

Nociception Coma Scale (NCS)

Intervention Type: DIAGNOSTIC_TEST

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

minimally conscious state

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.

Group Type: EXPERIMENTAL

Nociception Coma Scale (NCS)

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Nociception Coma Scale (NCS)

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

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

the Face Legs Activity Cry and Consolability (FLACC)

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).

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 53 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hangzhou Normal University

OTHER

Sponsor Role: lead

Responsible Party

Jing Wang

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Haibo Di, Pro

Role: STUDY_CHAIR

International Vegetative State and Consciousness Science Institute, Hangzhou Normal University

Locations

International Vegetative State and Consciousness Science Institute, Hangzhou Normal University

Hangzhou, Zhejiang, China

Countries

China

References

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.

Reference Type: BACKGROUND

PMID: 22906615 (View on PubMed)

Other Identifiers

2017R423055

Identifier Type: -

Identifier Source: org_study_id