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

Basic Information

Recruitment status	Complete: follow-up continuing
Health condition(s) or Problem(s) studied	Cerebrovascular Disease
Date of first enrollment	2025/05/22
Target sample size	53
Countries of recruitment	Japan
Study type	Observational
Intervention(s)

Outcome(s)

Primary Outcome

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

Secondary Outcome

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

Key inclusion & exclusion criteria

Age minimum	18years-old
Age maximum	100years-old
Gender	Male and Female
Include criteria	Age 18 years or older 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). No use of muscle relaxants, analgesics, or sedatives within 24 hours prior to the assessment
Exclude criteria	Diagnosed as Emerged from Minimal Conscious State (EMCS) based on the 2 consecutive CRS-R assessments performed Presence of neurodegenerative disease (e.g., dementia) History of psychiatric disorders Presence of mechanical ventilation