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A study to assess and compare the effectiveness of headset-based passive distraction (HBPD) using virtual reality with headset-based interactive distraction (HBID) using mixed reality on minimizing dental anxiety and pain in children during intraoral injection.

Effect of headset-based distraction using passive virtual reality and interactive mixed reality on dental anxiety in children: a split-mouth randomized cross-over clinical trial. - NIL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/097552
Enrollment
100
Registered
2025-11-17
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Group HBID: Headset based interactive distraction (HBID) using mixed reality.: HEADSET WILL BE USED TO PLAY GAME DURING DENTAL TREATMENT Control Intervention1: Group HBPD: Headset based

Sponsors

UNIVERSITY COLLEGE OF MEDICAL SCIENCES
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: INCLUSION CRITERIA: 1. Children aged 8-12 years of both sexes. 2. Children requiring dental treatment in the mandibular arch under local anesthesia. 3. Children belonging to American Society of Anesthesiologists (ASA) category I. 4. Children belonging to Frankl Behavior Rating of 2 (negative) or 3 (positive). 5. Children whose parents agree to take part in the study.

Exclusion criteria

Exclusion criteria: EXCLUSION CRITERIA: 1. Children having undergone any previous dental treatment. 2. Children allergic to local anesthesia (confirmed through a patch test). 3. Children with known intellectual or developmental disabilities. 4. Children having undergone any previous pharmacological behavior management. 5. Children requiring emergency dental care. 6. Children with a known history of epilepsy. 7. Children with known visual impairment. 8. Children with injuries to head/face that would prohibit wearing the headset. 9. Children with any known skin infection. 10. Children with a known history of vertigo and claustrophobia.

Design outcomes

Primary

MeasureTime frame
To assess and compare the effectiveness of HBPD using virtual reality with HBID using mixed reality on dental anxiety using an objective scale and physiological parameters for children scheduled to undergo dental treatment which requires intraoral injection.Timepoint: IN THE WAITING AREA, BEFORE START OF TREATMENT, DURING TREATMENT AND AFTER TREATMENT—

Secondary

MeasureTime frame
To assess & compare the effectiveness of HBPD using virtual reality with HBID using mixed reality on pain for children scheduled to undergo dental treatment.Timepoint: AFTER TREATMENT COMPLETION;To assess and compare the effectiveness of HBPD using virtual reality with HBID using mixed reality on behaviour at the end of dental treatment.Timepoint: BEFORE AND AFTER TREATMENT;To evaluate the acceptability and feasibility of the headset used by children, as assessed by parents at the end of treatment.Timepoint: AFTER TREATMENT COMPLETION;To evaluate comfort of the headset used through a researcher-based questionnaire in both the groups, as answered by children at the end of treatment.Timepoint: AFTER TREATMENT COMPLETION—

Countries

India

Contacts

Public ContactURVI BHATIA

UNIVERSITY COLLEGE OF MEDICAL SCINECES

urvibhatia.1998@gmail.com9999745735

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026