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Effectiveness of non-immersive virtual reality in the management of procedure-related pain in preschool children: a randomized clinical trial

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Abstract

The objective of this study is to assess the effectiveness of non-immersive virtual reality as a pain-distraction measure in children between the ages of 3 and 5 years undergoing painful injection procedures in an outpatient setting. We carried out a randomized, unmasked clinical trial in children undergoing venipuncture or intramuscular injection procedures. Patients were randomized to a distraction virtual reality video or standard care. After the procedure, three independent observers (parents, researchers, nursing staff) rated pain on the LLANTO pain scale. We recruited 122 subjects, half of which were randomized to virtual reality. The median age was of approximately 60 months (IQR: 15 months), and the sample was balanced with regard to sex. There were significant differences in LLANTO scales scores between the VR subjects and controls of − 3.34 (95% CI − 4.15; − 2.54), − 3.02 (95% CI − 3.90; − 2.14), and − 2.98 (95% CI − 3.87; − 2.09), as rated by parents, researchers, and nursing staff, respectively. Agreement between raters was high for all three types of observers, with Cohen Kappas over 0.79 in all cases. Bivariate analysis showed reductions in the risk of obtaining higher scores in the LLANTO scale. Linear regression models showed a reduction of approximately 3 points in the scale, regardless of the type of observer. These models were adjusted for sex, age, kind of procedure, use of prior analgesia, and recruitment center.

Conclusions: Non-immersive virtual reality is an effective adjunctive therapy for the reduction of pain in children undergoing painful injection procedures in an outpatient setting. This strategy may be used to improve the quality of care in pediatric outpatient services.

Trial registration: ClinicalTrials.gov Identifier: NCT03985930 (Registered June 14, 2019).

What is Known:

•The use of immersive virtual reality (VR) has been described as an effective adjunctive distraction method during painful procedures in children over 5 years.

What is New:

•The utility of non-immersive VR in children below that age is not yet clear. This randomized clinical trial comparing non-immersive VR vs. standard care showed an average reduction of three points in the LLANTO pain scale favoring non-immersive VR. Non-immersive VR is an effective and inexpensive non-pharmacological technique that reduces fear and pain in pediatric patients.

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Data availability

The raw data supporting the conclusions of this article will be made available by the corresponding author only if this request is approved by the Research Ethics Committee of Fundación Universitaria Sanitas, Bogotá D.C., Colombia, according to the prevailing regulation regarding patient confidentiality protection in Colombia.

Abbreviations

IQR:

Interquartile range

SES:

Socioeconomic status

VR:

Virtual reality

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Author information

Authors and Affiliations

  1. School of Medicine, Salud de la Infancia Research Group, Fundación Universitaria Sanitas, Bogotá, D.C., Colombia

    Jhon Camacho-Cruz & Johanna M. Bolaños

  2. Research Unit, Fundación Universitaria Sanitas, Sede Salitre, Ninth Floor, Bogotá, D.C., 111321, Colombia

    María A. Palacios-Ariza

  3. School of Medicine, Fundación Universitaria Sanitas, Bogotá, D.C., Colombia

    Luisa Orrego-Celestino, Natalia Valbuena-Velandia & Laura Paez-Castellanos

  4. Neuroscience Research Group (NeURos), School of Medicine and Health Sciences, Universidad del Rosario, Bogotá, D.C., Colombia

    Iván Pradilla

Authors
  1. Jhon Camacho-Cruz
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Contributions

Drs. JCC and MAPA had primary responsibility for protocol development, patient screening, enrollment, outcome assessment, preliminary data analysis, and writing the manuscript. Drs. LOC, NVV, and LPC participated in the patient screening, enrollment, and outcome assessment for the study and contributed to the writing of the manuscript. Dr. JMB supervised data collection and contributed to the writing of the manuscript. Dr IP supervised the design and execution of the study, performed the final data analyses, and contributed to the writing of the manuscript.

Corresponding author

Correspondence to María A. Palacios-Ariza.

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Communicated by Piet Leroy

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Camacho-Cruz, J., Palacios-Ariza, M.A., Orrego-Celestino, L. et al. Effectiveness of non-immersive virtual reality in the management of procedure-related pain in preschool children: a randomized clinical trial. Eur J Pediatr 182, 4103–4112 (2023). https://doi.org/10.1007/s00431-023-05070-5

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