Pilot Feasibility Clinical Trial of Virtual Reality for Pain Management During Repeated Pediatric Laser Procedures: Study Protocol for a Randomized Clinical Trial (Preprint)
Notice bibliographique
Résumé
Abstract Background Lasers have wide applications in medicine but are associated with pain and anxiety, particularly in younger patients. Pain mitigation is often limited to topical anesthetics in the outpatient setting. Distraction techniques are limited by the need for ocular protection, which can include eye patches that completely occlude vision. Virtual reality (VR) is effective at managing procedural pain and anxiety during other short medical procedures and is a promising tool for this population. Objective This trial aims to assess the safety, feasibility, and efficacy of the virtual reality pain alleviation therapeutic (VR-PAT) for pain management during outpatient laser procedures. Methods A total of 40 patients requiring outpatient laser therapy for at least 2 sessions will be recruited from a pediatric hospital in the Midwestern United States for this crossover randomized, 2-arm clinical trial. During the first laser visit, the participants will be randomly assigned to either play the VR-PAT game during their procedure or wear the headset with a dark screen. Participants will answer questions about their pain (Numeric Rating Scale 0‐10), anxiety (State-Trait Anxiety Inventory for Children, Numeric Rating Scale 0‐10, and Modified Yale Preoperative Anxiety Scale), and pain medication usage. Those playing the VR-PAT will report simulator sickness symptoms and their experience playing the game. At their second laser visit, participants will cross over to the opposite intervention. The primary outcomes are the differences in self-reported pain and anxiety between the 2 interventions. Feasibility outcomes include the proportion of screened patients who were eligible, have given consent, and completed both visits, as well as adverse events reported. To evaluate the efficacy of pain reduction, composite pain scores, and pain medication usage will be calculated for each laser visit. To evaluate the efficacy of anxiety reduction, the change in Modified Yale Preoperative Anxiety Scale scores will be compared between control and VR groups at each visit using the Wilcoxon rank sum tests. All statistical analyses will follow the intention-to-treat principle with regard to intervention assignment at each visit. Results The study was funded in January 2023 and began enrollment at that time. A total of 44 participants were recruited, and data collection was completed in November 2025, with 40 participants completing both visits. The sample was balanced, with 40 participants using the intervention and participating in the control condition. The age range of the complete sample was 6 to 21 years at recruitment, and 22 (55%) were female. Data analysis is in progress with final results planned for June 2026. Conclusions Findings from this innovative randomized clinical trial will provide early evidence on the efficacy of the VR-PAT in reducing self-reported pain and anxiety during outpatient laser procedures. The results from this trial will inform a large-scale, multisite study.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,014 | 0,016 |
| Méta-épidémiologie (sens strict) | 0,004 | 0,002 |
| Méta-épidémiologie (sens large) | 0,005 | 0,002 |
| Bibliométrie | 0,001 | 0,001 |
| Études des sciences et des technologies | 0,002 | 0,002 |
| Communication savante | 0,002 | 0,002 |
| Science ouverte | 0,002 | 0,001 |
| Intégrité de la recherche | 0,005 | 0,005 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,069 | 0,010 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».