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COMFORTneo scale: a reliable and valid instrument to measure prolonged pain in neonates?

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Abstract

Objective

We studied the reliability and validity of the COMFORTneo scale, designed to measure neonatal prolonged pain.

Study design

This 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.

Result

Intra-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.

Conclusion

The COMFORTneo can be used to reliably and validly assess pain in NICU patients.

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Fig. 1: Study design.
Fig. 2: Scatter plot inter-rater reliability.
Fig. 3: Scatter plot construct validity 1.
Fig. 4: Scatter plot construct validity 2.

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Data availability

The datasets generated and analyzed during the current study are available from the corresponding author upon reasonable request.

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Author information

Authors and Affiliations

  1. Department of Pediatrics, Division of Neonatology, Erasmus MC –Sophia Children’s Hospital, Rotterdam, the Netherlands

    Naomi J. Meesters, Gerbrich E. van den Bosch, Sinno H. P. Simons & Monique van Dijk

  2. Nursing and Midwifery Sciences, Centre for Research and Innovation in Care, Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium

    Tinne Dilles

  3. Department of Biostatistics, Erasmus MC, Rotterdam, the Netherlands

    Joost van Rosmalen

  4. Department of Epidemiology, Erasmus MC, Rotterdam, the Netherlands

    Joost van Rosmalen

  5. Intensive Care and Department of Pediatric Surgery, Erasmus MC –Sophia Children’s Hospital, Rotterdam, the Netherlands

    Monique van Dijk

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  1. Naomi J. Meesters
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Contributions

NM conceptualized and designed the study, assessed pain together with the NICU nurses, carried out the initial analyses, drafted the initial manuscript, and approved the final manuscript as submitted. TD conceptualized and designed the study, supervised initial analyses, critically reviewed and revised the manuscript, and approved the final manuscript as submitted. JvR gave his advice regarding statistical analysis, supervised initial analyses, critically reviewed and revised the manuscript, and approved the final manuscript as submitted. GvdB supervised initial analyses, contributed to the interpretation of the work, critically reviewed and revised the manuscript, and approved the final manuscript as submitted. SS supervised initial analyses, contributed to the interpretation of the work, critically reviewed and revised the manuscript, and approved the final manuscript as submitted. MvD conceptualized and designed the study, supervised initial analyses, contributed to the interpretation of the work, critically reviewed and revised the manuscript, and approved the final manuscript as submitted. All authors agree to be accountable for all aspects of the work.

Corresponding author

Correspondence to Naomi J. Meesters.

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Meesters, N.J., Dilles, T., van Rosmalen, J. et al. COMFORTneo scale: a reliable and valid instrument to measure prolonged pain in neonates?. J Perinatol 43, 595–600 (2023). https://doi.org/10.1038/s41372-023-01628-1

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