Effectiveness of Virtual Reality in Reducing Anxiety and Pain During the First Postoperative Orthopedic Dressing Change in Pediatric Patients (VR OrthoPed)
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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Liguria
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Genoa, Liguria, Italia, 16132
- Dipartimento di scienze della salute, DISSAL - UNIGE
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
Tar imot friske frivillige
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
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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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Anxiety Assessed Using the Visual Analogue Scale for Anxiety
Tidsramme: Immediately before and immediately after the first postoperative orthopedic dressing procedure
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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
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Pain Intensity Assessed Using the Faces Pain Scale
Tidsramme: 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.
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Immediately before and immediately after the first postoperative orthopedic dressing procedure
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Change in Pain Intensity Assessed Using the Numeric Rating Scale
Tidsramme: 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.
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Immediately before and immediately after the first postoperative orthopedic dressing procedure.
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- VR OrthoPed
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