Observational studyJournal of perinatology : official journal of the California Perinatal Association2023
COMFORTneo scale: a reliable and valid instrument to measure prolonged pain in neonates?
Observational study in Journal of perinatology : official journal of the California Perinatal Association, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06985290 (Comparative Efficacy of Dexmedetomidine Versus Morphine in Alleviating Secondary Brain Injury, When Used for Sedation During Hypothermia Therapy in Neonates), which is not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Comparative Efficacy of Dexmedetomidine Versus Morphine in Alleviating Secondary Brain Injury, When Used for Sedation During Hypothermia Therapy in Neonates: A Pilot Randomized Trial
Who cites it
11 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Clinical rating scales for assessing pain in newborn infants.The Cochrane database of systematic reviews · 2025Pooled it
- Effects of live-performed sansula music versus storytelling on physiological and behavioral parameters in preterm infants: a randomized controlled trial.Scientific reports · 2025Trial
- Impact of daily music on comfort scores in preterm infants: a randomized controlled trial.Pediatric research · 2025Trial
- Association between exposure to stress and experienced discomfort in preterm infants.Pediatric research · 2026Article
- A Comprehensive Evidence-Based Review of Non-Pharmaceutical Interventions for Neonatal Pain.Journal of pain research · 2026Review
- The effect of comprehensive developmental positioning program training on nurses' performance and infant comfort hospitalized in the neonatal intensive care unit.BMC medical education · 2025Article
- Analysis of vibration and comfort in infants.Scientific reports · 2025Article
- A Critical Evaluation of the COMFORTneo Scale's Validity and Applicability for Preterm Infants.Paediatric & neonatal pain · 2025Article
- Quality Improvement Intervention Decreases Pain and Adverse Events Due to Heel Lances in Infants.Children (Basel, Switzerland) · 2024Article
- NON-pharmacological Approach Less Invasive Surfactant Administration (NONA-LISA) trial: protocol for a randomised controlled trial.Pediatric research · 2024Article
- COMFORTneo scale in preterm infants during live performed music therapy-Difference between close physical contact and hand touch contact.Frontiers in neuroscience · 2024Article
Corrections and comments
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveWe studied the reliability and validity of the COMFORTneo scale, designed to measure neonatal prolonged pain. STUDY
designThis prospective observational study evaluated four clinimetric properties of the COMFORTneo scale from NICU nurses' assessments of neonates' pain. Intra-rater reliability was determined from three video fragments at two time points. Inter-rater reliability and construct validity were determined in five neonates per nurse with the COMFORTneo and numeric rating scales (NRS) for pain and distress. Pain scores using N-PASS were correlated with COMFORTneo scores to further evaluate construct validity.
resultIntra-rater reliability: Twenty-two nurses assessed pain twice with an intraclass correlation coefficient (ICC) of 0.70. Inter-rater reliability: The ICC for 310 COMFORTneo scores together with 62 nurses was 0.93. Construct validity: Correlation between COMFORTneo and NRS pain, distress, and N-PASS was 0.34, 0.72, and 0.70, respectively.
conclusionThe COMFORTneo can be used to reliably and validly assess pain in NICU patients.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.