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Virtual Reality-Assisted Cast Application in Children With Forearm Fractures (VR-CAST)

1. července 2026 aktualizováno: Lezgin Mert, Başakşehir Çam & Sakura City Hospital

Does Virtual Reality Reduce Pain, Anxiety, Physiologic Stress, and Return-Visit Fear During Pediatric Forearm Casting? A Randomized Controlled Trial

This prospective randomized controlled trial will evaluate whether virtual reality can reduce procedural distress in children undergoing cast application for forearm fractures. Children will be assigned to either a virtual reality group or a standard care group. In the virtual reality group, children will watch a 3-minute child-friendly animated educational video using a VR headset during cast application. The video explains the casting procedure, how to protect the cast, and what the child should do after the cast is applied.

The study will compare pain, anxiety, heart rate response, caregiver anxiety, and procedure-related fear between the two groups. The casting team will assess the child during the procedure. One day after cast application, each child will undergo an approximately 30-minute evaluation by a child psychiatry clinician who is blinded to group allocation. This follow-up assessment will evaluate the child's current anxiety, anxiety related to the cast experience, fear of returning to the hospital or doctor, and fear-related behaviors after the procedure.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Detailní popis

Forearm fractures are common injuries in children and frequently require cast immobilization. Although cast application is a routine orthopedic procedure, children may experience pain, anxiety, fear, and physiologic stress during the procedure. In some children, this experience may also lead to fear of returning to the hospital or doctor, sometimes referred to as doctor-related or white coat-related fear.

Virtual reality may help children during medical procedures by providing immersive visual and auditory distraction. In addition, an age-appropriate educational video may reduce uncertainty by explaining what will happen during the procedure and how the child should care for the cast afterward.

This study is designed as a prospective, randomized, parallel-group clinical trial. Children with forearm fractures requiring cast application will be randomized into two groups: a virtual reality group and a standard care group. Children in the virtual reality group will wear a Meta Quest 3 headset during cast application and watch a 3-minute child-friendly animated educational video generated using Google Flow. The video explains the cast application process, cast protection, and post-cast care instructions. Children in the standard care group will undergo routine cast application without virtual reality. Apart from the virtual reality intervention, all clinical care will be the same between the two groups.

During cast application, the orthopedic casting team will record procedural pain, procedural anxiety, heart rate before the procedure, mean heart rate during the procedure, heart rate after a 2-minute recovery period, procedure duration, whether the virtual reality headset was removed, and whether nausea, dizziness, or discomfort occurred. Caregivers will also rate the child's anxiety, their own anxiety, and the child's pain before and after the procedure.

One day after cast application, each child will undergo an approximately 30-minute follow-up assessment by a child psychiatry clinician who is blinded to group allocation. Children and caregivers will be instructed not to disclose whether virtual reality was used. This blinded assessment will evaluate the child's current anxiety, anxiety related to the cast experience, anxiety while returning to the hospital or doctor, reluctance to return to the doctor, fear-related behaviors at home such as crying or sleep disturbance, and distress when remembering the cast procedure.

The primary objective of the study is to determine whether virtual reality reduces cast-related anxiety and subsequent doctor-related fear after cast application. Secondary objectives include evaluating the effect of virtual reality on procedural pain, procedural anxiety, heart rate response, caregiver anxiety, procedure duration, virtual reality tolerability, and caregiver preference for future use of virtual reality during similar procedures.

Typ studie

Intervenční

Zápis (Odhadovaný)

120

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

  • Turecko (Türkiye)
    • Istanbul
      • Istanbul, Istanbul, Turecko (Türkiye), 34010
        • Nábor
        • Basaksehir Cam ve Sakura City Hospital
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dítě

Přijímá zdravé dobrovolníky

Ne

Popis

Inclusion Criteria:

  • Children aged 4 to 15 years.
  • Diagnosis of an isolated forearm fracture requiring cast application with traction (greenstick injuries plastic deformation if NOT over 20 degrees bayonet apposition ok if <10 years and growth remains)
  • First cast application for the current fracture episode.
  • Typically developing children without a known developmental delay or cognitive impairment that would prevent participation in the study assessments.
  • Ability of the child to understand age-appropriate instructions and respond to pain, anxiety, and fear-related assessments with caregiver assistance when necessary.
  • At least one upper extremity free of immobilization, allowing heart rate assessment during the procedure.
  • Parent or legal guardian able to provide written informed consent.
  • Child assent when appropriate according to age and local ethics committee requirements.
  • Ability and willingness of the child and caregiver to attend an approximately 30-minute blinded child psychiatry assessment 1 day after cast application.

Exclusion Criteria:

  • Open forearm fracture.
  • Multiple trauma or an additional painful injury that may affect pain, anxiety, or fear assessment.
  • Need for emergency surgery, procedural sedation, or general anesthesia during cast application.
  • Previous participation in this study.
  • Known developmental delay, cognitive impairment, autism spectrum disorder with inability to complete study assessments, or severe psychiatric disorder that may interfere with questionnaire-based evaluation.
  • Known epilepsy, photosensitive seizure disorder, severe motion sickness, vestibular disorder, or any condition considered unsafe for VR headset use.
  • Visual or hearing impairment preventing use of the VR intervention or completion of the assessments.
  • Head, face, or scalp injury preventing safe or comfortable use of a VR headset.
  • Nausea, dizziness, or severe discomfort before the procedure that would prevent VR use.
  • Refusal of the child or caregiver to participate.
  • Inability to complete the 1-day child psychiatry follow-up assessment.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Podpůrná péče
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Virtual Reality-Assisted Cast Application
Children in this group will undergo cast application while watching a 3-minute child-friendly educational animated video through a VR headset. The video explains the cast application procedure, cast protection, and post-cast care instructions. Apart from the VR intervention, routine orthopedic care will be provided.
Behaviorální: Virtual Reality-Based Educational Animation
Children assigned to the virtual reality group will watch a 3-minute child-friendly educational animated video through a VR headset during cast application. The video explains the cast application procedure, cast protection, and post-cast care instructions. The intervention is intended to reduce procedural distress through immersive visual and auditory distraction and age-appropriate education.
Aktivní komparátor: Standard Cast Application
Children in this group will undergo routine cast application without virtual reality. Standard verbal explanation and routine orthopedic care will be provided by the casting team.
Jiný: Standard Care
Children assigned to the control group will undergo routine cast application without virtual reality. Standard verbal explanation and routine orthopedic care will be provided by the casting team.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Child Psychiatry-Assessed Cast Experience Anxiety Score at 1 Day
Časové okno: 1 day after cast application
Cast-related fear and anxiety will be assessed 1 day after cast application by a child psychiatry clinician blinded to group allocation using a structured questionnaire. The assessment will evaluate the child's fear or anxiety related to the cast experience, reluctance to return to the doctor or hospital, fear-related behaviors at home such as crying or sleep disturbance, and distress when remembering the cast procedure.
1 day after cast application

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Procedural Anxiety Score During Cast Application
Časové okno: During cast application
The orthopedic casting team will assess the child's anxiety during cast application using a 0-100 score, where higher scores indicate greater procedural anxiety.
During cast application
Procedural Pain Score During Cast Application
Časové okno: During cast application
The orthopedic casting team will assess the child's pain during cast application using a 0-10 score, where higher scores indicate greater procedural pain.
During cast application
Change in Heart Rate During Cast Application
Časové okno: Before, during, and 2 minutes after cast application
Heart rate will be recorded before cast application, during the procedure, and after a 2-minute recovery period. Changes in heart rate from baseline to the procedural and recovery periods will be compared between groups.
Before, during, and 2 minutes after cast application
Procedure Duration
Časové okno: During cast application
The duration of cast application will be recorded in minutes from the start of the cast application procedure to completion of the procedure. Procedure duration will be compared between the virtual reality group and the standard care group.
During cast application
Physician-Rated Procedural Difficulty Score
Časové okno: During cast application
The physician performing the cast application will rate the procedural difficulty using a 0-10 score according to the child's cooperation, movement, crying, fear response, and overall behavioral reaction during cast application. Higher scores indicate greater procedural difficulty.
During cast application
Child Behavioral Response During Cast Application
Časové okno: During cast application
The child's behavioral response during cast application will be assessed by the casting physician. The assessment will include cooperation, crying, avoidance behavior, agitation, movement during the procedure, and overall tolerance of the cast application.
During cast application
Caregiver-Rated Child Anxiety
Časové okno: Immediately after cast application
Caregivers will rate how anxious they think their child is using a 0-100 score, where higher scores indicate greater child anxiety.
Immediately after cast application
Caregiver Anxiety Score
Časové okno: Immediately after cast application
Caregivers will rate their own anxiety using a 0-100 score, where higher scores indicate greater caregiver anxiety.
Immediately after cast application
Caregiver-Rated Child Pain Before and After Cast Application
Časové okno: Before and immediately after cast application
Caregivers will rate the child's pain before and after cast application using a 0-10 score, where higher scores indicate greater pain.
Before and immediately after cast application
Doctor-Related Fear at Follow-up
Časové okno: 1 day after cast application
Doctor-related fear after the cast experience will be assessed by a blinded child psychiatry clinician using a structured questionnaire. The assessment will include anxiety while returning to the hospital or doctor and reluctance to return to the doctor after the cast experience.
1 day after cast application
Post-Procedural Fear-Related Behaviors at Home
Časové okno: From cast application to 1-day follow-up
Fear-related behaviors at home after cast application will be assessed by the blinded child psychiatry clinician using caregiver and child responses. These behaviors may include fear, crying, sleep disturbance, reluctance to visit the doctor, or other procedure-related distress.
From cast application to 1-day follow-up
Distress When Remembering the Cast Procedure
Časové okno: 1 day after cast application
The child's distress when remembering the cast application procedure will be assessed by the blinded child psychiatry clinician using a structured questionnaire item. Higher scores or more severe responses indicate greater procedure-related distress.
1 day after cast application
Caregiver Preference for Future Virtual Reality Use
Časové okno: Immediately after cast application
Caregivers will be asked whether they would want virtual reality to be used again if a similar procedure is required. Responses will be recorded as yes, no, or undecided.
Immediately after cast application

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Başakşehir Çam & Sakura City Hospital

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

5. prosince 2025

Primární dokončení (Odhadovaný)

30. srpna 2026

Dokončení studie (Odhadovaný)

1. září 2026

Termíny zápisu do studia

První předloženo

27. června 2026

První předloženo, které splnilo kritéria kontroly kvality

1. července 2026

První zveřejněno (Aktuální)

6. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

6. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

1. července 2026

Naposledy ověřeno

1. července 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 2024KAEK11

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

De-identified individual participant data underlying the results reported in the published article may be shared upon reasonable request. Shared data will not include names, national identification numbers, contact information, or any directly identifiable personal information. Because the study includes children and child psychiatry assessments, data sharing will be limited to anonymized research data and will require approval by the principal investigator and compliance with applicable ethics committee and institutional regulations.

Časový rámec sdílení IPD

Data will become available beginning 6 months after publication of the main study results and will be available for 5 years.

Kritéria přístupu pro sdílení IPD

Data may be shared with qualified researchers who submit a scientifically sound research proposal. Requests will be reviewed by the principal investigator. Data will be shared only for approved research purposes and after completion of any required data use agreement and ethics or institutional approvals.

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY
  • MÍZA
  • ICF
  • ANALYTIC_CODE
  • CSR

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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