Reliability and Validity of the Japanese Version of the Nociception Coma Scale-Revised: A Pain Assessment Tool for Patients with Impaired Consciousness

Reliability and Validity of the Japanese Version of the Nociception Coma Scale-Revised: A Pain Assessment Tool for Patients with Impaired Consciousness - Reliability and Validity of the Japanese Version of the Nociception Coma Scale-Revised: A Pain Assessment Tool for Patients with Impaired Consciousness

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000061985

Enrollment

Registered

2026-06-20

Start date

2025-05-22

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute brain injury

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age 18 years or older 2. Diagnosis of unresponsive wakefulness syndrome (UWS), minimally conscious state minus (MCS-), or minimally conscious state plus (MCS+) based on the Japanese version of the Coma Recovery Scale-Revised (CRS-R). 3. No use of muscle relaxants, analgesics, or sedatives within 24 hours prior to the assessment

Exclusion criteria

Exclusion criteria: 1. Diagnosed as Emerged from Minimal Conscious State (EMCS) based on the 2 consecutive CRS-R assessments performed 2. Patients with pre-existing communication difficulties prior to admission 3. History of psychiatric disorders 4. Presence of mechanical ventilation 5. Presence of a tracheostomy

Design outcomes

Primary

Measure	Time frame
Test-retest reliability: The Japanese version of the NCS-R, administered twice on the same day by Rater A	—

Secondary

Measure	Time frame
Inter-rater reliability: The Japanese version of the NCS-R, assessed by Rater A and Rater B on the same day Concurrent validity: The Japanese version of the NCS-R, the Japanese version of the FLACC Behavioral Assessment Scale (Face, Legs, Activity, Cry, Consolability), and the Japanese version of the Critical-Care Pain Observation Tool (CPOT-J), all assessed by Rater A on the same day Cutoff Values: Japanese Version of the NCS-R When Rater A Presented Invasive and Non-Invasive Stimuli	—

Measure

Time frame

Inter-rater reliability: The Japanese version of the NCS-R, assessed by Rater A and Rater B on the same day Concurrent validity: The Japanese version of the NCS-R, the Japanese version of the FLACC Behavioral Assessment Scale (Face, Legs, Activity, Cry, Consolability), and the Japanese version of the Critical-Care Pain Observation Tool (CPOT-J), all assessed by Rater A on the same day Cutoff Values: Japanese Version of the NCS-R When Rater A Presented Invasive and Non-Invasive Stimuli

—

Countries

Japan

Contacts

Public ContactTakayuki Kitano

Hamamatsu Medical Center Department of Rehabilitation Technology

kitano.hmc@gmail.com0570-07-1113

Outcome results