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Effectiveness of Virtual Reality in Reducing Anxiety and Pain During the First Postoperative Orthopedic Dressing Change in Pediatric Patients (VR OrthoPed)

22 juli 2026 uppdaterad av: Gianluca Catania

Effectiveness of Virtual Reality in Reducing Anxiety and Pain During the First Postoperative Orthopedic Dressing Change in Pediatric Patients: A Randomized Controlled Trial

The goal of this randomized clinical trial is to learn whether immersive virtual reality can reduce anxiety and pain in children and adolescents undergoing postoperative orthopedic dressing changes. The main questions it aims to answer are:

Does immersive virtual reality reduce anxiety during postoperative dressing changes compared with standard care?

Does immersive virtual reality reduce pain and physiological signs of distress, such as changes in heart rate and respiratory rate?

Researchers will compare participants who use an immersive virtual reality headset during the dressing change with participants who receive standard care without virtual reality.

Participants will:

Be randomly assigned to the virtual reality group or the standard care group

Undergo a postoperative orthopedic dressing change with or without immersive virtual reality

Report their anxiety and pain before and after the procedure

Have their heart rate and respiratory rate measured before, during, and after the dressing change

Studieöversikt

Detaljerad beskrivning

Postoperative orthopedic dressing changes can cause anxiety, pain, and physiological distress in pediatric patients. Immersive virtual reality may provide a non-pharmacological form of distraction by directing the participant's attention away from the clinical procedure and toward an engaging virtual environment.

This randomized clinical trial was conducted in a pediatric orthopedic unit to evaluate the use of immersive virtual reality during postoperative dressing changes. After enrollment and baseline assessment, participants were randomly assigned to receive either immersive virtual reality in addition to the usual dressing procedure or standard care alone.

Participants assigned to the virtual reality group wore a head-mounted display and viewed an immersive virtual environment during the dressing change. Participants assigned to the standard care group underwent the same clinical procedure according to usual practice without virtual reality. The dressing change was performed by the clinical team in accordance with routine postoperative care.

Anxiety, pain, heart rate, respiratory rate and peripheral oxygen saturation were assessed at predefined time points before, during, and after the procedure, as applicable. These measurements were used to examine whether immersive virtual reality was associated with reduced psychological and physiological distress during the dressing change.

The study was designed to provide evidence on the potential usefulness of immersive virtual reality as a non-drug supportive intervention during postoperative procedures in pediatric orthopedic care.

Studietyp

Interventionell

Inskrivning (Faktisk)

48

Fas

  • Inte tillämpbar

Kontakter och platser

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Studieorter

    • Liguria
      • Genoa, Liguria, Italien, 16132
        • Dipartimento di scienze della salute, DISSAL - UNIGE

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn
  • Vuxen

Tar emot friska volontärer

Nej

Beskrivning

Inclusion Criteria

  • Patients aged 6-18 years.
  • Undergoing corrective orthopedic surgery for congenital or acquired limb deformities, with or without external fixation devices, or spinal arthrodesis for scoliosis or spondylolisthesis.
  • Undergoing the first postoperative wound dressing procedure.
  • Written informed consent obtained from a parent or legal guardian.
  • Assent obtained from the participant, when appropriate. Exclusion Criteria
  • Neurological disorders.
  • History of epilepsy.
  • Prematurity.
  • Sensory impairments preventing the use of the virtual reality headset.
  • Cognitive impairments preventing the use of the virtual reality headset.
  • Motor limitations preventing the use of the virtual reality headset.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Immersive Virtual Reality Plus Standard Care
Participants received the first postoperative orthopedic dressing procedure according to routine clinical practice while using an immersive virtual reality headset. The headset displayed an immersive virtual environment throughout the dressing procedure as a non-pharmacological distraction intervention. Standard clinical monitoring and nursing care were provided.
Participants used an immersive virtual reality headset during the first postoperative orthopedic dressing procedure. The headset presented an immersive virtual environment intended to divert attention from the clinical procedure and reduce anxiety, pain, and physiological stress. The virtual reality intervention was provided in addition to the routine postoperative dressing care delivered by the clinical team. The headset was worn during the dressing procedure and removed after its completion.
Aktiv komparator: Standard Care Alone
Participants received the first postoperative orthopedic dressing procedure according to routine clinical practice without the use of immersive virtual reality. Standard clinical monitoring and nursing care were provided.
Participants underwent the first postoperative orthopedic dressing procedure according to routine clinical practice without the use of immersive virtual reality. Standard nursing care and clinical monitoring were provided throughout the procedure.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Anxiety Assessed Using the Visual Analogue Scale for Anxiety
Tidsram: Immediately before and immediately after the first postoperative orthopedic dressing procedure
Anxiety was assessed using the Visual Analogue Scale for Anxiety (VAS-A), a 100 mm horizontal scale ranging from 0, indicating no anxiety, to 100, indicating maximum anxiety. Higher scores indicate greater anxiety. Change in anxiety was calculated as the score immediately after the procedure minus the score immediately before the procedure. A negative change score indicates a reduction in anxiety.
Immediately before and immediately after the first postoperative orthopedic dressing procedure

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Pain Intensity Assessed Using the Faces Pain Scale
Tidsram: Immediately before and immediately after the first postoperative orthopedic dressing procedure
Pain intensity in participants aged 6 to 10 years was assessed immediately before and immediately after the first postoperative orthopedic dressing procedure using the Faces Pain Scale. Higher scores indicate greater pain intensity. Change in pain was calculated as the post-procedure score minus the pre-procedure score.
Immediately before and immediately after the first postoperative orthopedic dressing procedure
Change in Pain Intensity Assessed Using the Numeric Rating Scale
Tidsram: Immediately before and immediately after the first postoperative orthopedic dressing procedure.
Pain intensity in participants older than 10 years was assessed immediately before and immediately after the first postoperative orthopedic dressing procedure using the Numeric Rating Scale (0-10). Higher scores indicate greater pain intensity. Change in pain was calculated as the post-procedure score minus the pre-procedure score.
Immediately before and immediately after the first postoperative orthopedic dressing procedure.

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Samarbetspartners

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 september 2020

Primärt slutförande (Faktisk)

31 december 2025

Avslutad studie (Faktisk)

31 december 2025

Studieregistreringsdatum

Först inskickad

14 juli 2026

Först inskickad som uppfyllde QC-kriterierna

22 juli 2026

Första postat (Faktisk)

27 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

27 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

22 juli 2026

Senast verifierad

1 juli 2026

Mer information

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