Virtual Reality for Pain and Anxiety in Pediatric Dental Treatment
30 juni 2026 uppdaterad av: Randa Soussou, University of British Columbia
Effects of Immersive Virtual Reality on Pain, Anxiety, and Post-Procedural Experience in Pediatric Dental Treatment: A Randomized Controlled Trial
The goal of this clinical trial is to learn whether immersive virtual reality (VR) reduces pain and anxiety in children aged 6-12 years during routine dental procedures. The main questions it aims to answer are:
- Does VR distraction reduce self-reported pain and anxiety during dental treatment compared to standard behaviour guidance?
- Does VR distraction improve children's post-procedural experience and willingness to return for future dental visits?
Researchers will compare children using a VR headset during dental treatment to children receiving standard behaviour guidance techniques.
Participants will:
- Attend one routine dental appointment
- Be randomly assigned to wear a VR headset or receive standard care during their procedure
- Complete brief questionnaires about pain and anxiety before and after treatment
- Receive a follow-up phone call 24-72 hours after the appointment
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
80
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Randa Soussou
- Telefonnummer: 604-822-6819
- E-post: randa.soussou@dentistry.ubc.ca
Studieorter
-
-
British Columbia
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Vancouver, British Columbia, Kanada, V6T 1Z3
- UBC Graduate Pediatric Dental Clinic
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Kontakt:
- Randa Soussou
- Telefonnummer: 604-822- 6819
- E-post: randa.soussou@dentistry.ubc.ca
-
-
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
Tar emot friska volontärer
Ja
Beskrivning
Inclusion Criteria:
- Children aged 6 to 12 years
- Scheduled for a routine invasive dental procedure
- Accompanied by a parent or legal guardian
- Parent/guardian able to provide written informed consent
Exclusion Criteria:
- Children with visual or hearing impairments that would prevent use of the VR headset
- Children with a history of motion sickness
- Children with severe cognitive or developmental delays that would prevent completion of study measures
- Children who have previously participated in this study
- Children requiring emergency dental treatment
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: VR Distraction
Children wear an immersive VR headset during routine dental treatment as a non-pharmacological distraction intervention.
The VR headset provides an engaging visual and auditory environment to reduce pain and anxiety during the procedure.
|
A commercially available immersive VR headset used as a non-pharmacological distraction tool during routine pediatric dental procedures.
Children wear the headset throughout their treatment to engage with an interactive virtual environment designed to reduce pain and anxiety.
|
|
Aktiv komparator: Standard Behaviour Guidance
Children receive standard behaviour guidance techniques commonly used in pediatric dentistry, such as tell-show-do and positive reinforcement, without VR distraction.
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Standard behaviour guidance techniques routinely used in pediatric dentistry, including tell-show-do, positive reinforcement, and distraction through verbal communication and a TV screen.
No virtual reality headset is used.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Self-Reported Pain During Dental Procedure Using Faces Pain Scale
Tidsram: Baseline Pre-procedural and Immediately following the dental procedure (same day)
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Child self-reported pain assessed using the Faces Pain Scale (0-10 where 10 is the maximum pain felt): The child is asked to point to the Faces picture that reflect the pain level that they are feeling.
0= Relaxed and comfortable; 2-4= Mild discomfort; 6-8= Moderate pain; 10= Severe pain or discomfort Baseline pre-procedural and immediately following the dental procedure.
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Baseline Pre-procedural and Immediately following the dental procedure (same day)
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Physiological Stress Response (Heart Rate)
Tidsram: Baseline (Before the procedure), during and Immediately following the dental procedure
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Physiological markers of stress assessed via heart rate using a pulse oximeter device (pulse/minute)
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Baseline (Before the procedure), during and Immediately following the dental procedure
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Physiological Stress Response (Salivary alpha-Amylase) salivary alpha-amylase level (U/L) baseline before any dental treatment and immediately following the dental procedure
Tidsram: Salivary alpha-amylase level (U/L), measured at baseline (immediately prior to the start of the dental procedure) and again immediately following the dental procedure. Both samples are collected on the same day, during the single dental appointment.
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Using a swab to collect for a full 60-90 seconds by resting the swab inside the mouth, or collect in intervals by re-introducing the swab into the mouth as needed, until the lower third of the swab is saturated (some participants may require longer than 90 seconds of total collection time).
Salivary alpha-amylase level (U/L), measured at baseline (immediately prior to the start of the dental procedure) and again immediately following the dental procedure.
Both samples are collected on the same day, during the single dental appointment.
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Salivary alpha-amylase level (U/L), measured at baseline (immediately prior to the start of the dental procedure) and again immediately following the dental procedure. Both samples are collected on the same day, during the single dental appointment.
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
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 (Beräknad)
2 juni 2026
Primärt slutförande (Beräknad)
18 juni 2027
Avslutad studie (Beräknad)
30 juni 2027
Studieregistreringsdatum
Först inskickad
22 maj 2026
Först inskickad som uppfyllde QC-kriterierna
4 juni 2026
Första postat (Faktisk)
9 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
2 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
30 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- H25-03739 (Annan identifierare: UBC Clinical Research Ethics Board)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
OBESLUTSAM
IPD-planbeskrivning
A decision regarding individual participant data sharing has not yet been made.
This study involves children (a vulnerable population) and data sharing plans will be determined in accordance with UBC Research Ethics Board requirements
Läkemedels- och apparatinformation, studiedokument
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