Multisensory Approaches to Help Kids Handle Dental Checkups
Official title: Evaluation of the Effects of Virtual Reality and Weighted Blanket Use on Dental Anxiety Among School-Aged Children With High Dental Anxiety
Run by Bezmialem Vakif University · NCT07848542 · Data updated 2026-11-12
This study tests whether VR distraction, a weighted blanket, or both can help 5–9 year-olds stay calmer and tolerate dental procedures with local anesthesia.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 5 Years to 9 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Bezmialem Vakif University Academic / other |
| Locations | 1 site (Istanbul, Fatih) |
| Status | Recruiting |
| Started | August 19, 2026 |
| Main results expected | April 2027 |
| Study ends | April 2027 |
| Registry record updated | September 30, 2026 |
| Trial ID | NCT07848542 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 5–9 years with CFSS-DS score ≥39, requiring dental procedures with local anesthesia, and weighing 15–30 kg (ASA I–II).
✕Probably not a fit
Children who do not experience meaningful anxiety reduction or cooperation improvement from sensory-based interventions may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This four-arm randomized, single-blind trial compares standard behavior guidance to virtual reality distraction, deep-pressure stimulation with a weighted blanket, or a combination of both in children aged 5–9 with high dental anxiety. Outcomes include anxiety, cooperation, pain perception, and physiological responses measured before, during, and after treatment. The trial uses validated scales such as CFSS-DS, FIS, Frankl, FLACC, and Wong-Baker, and monitors heart rate and oxygen saturation. Participants are ASA I-II and weigh 15–30 kg, with procedures requiring local anesthesia.
Why it matters
Potential benefit: If successful, these non-pharmacologic approaches could reduce anxiety and improve cooperation during pediatric dental care.
How similar studies have gone: Previous work suggests non-pharmacologic distraction and sensory approaches can help reduce distress in pediatric dental settings, but direct comparisons like this are relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children aged between 5 and 9 years. * Children with a total score of 39 or higher on the Children's Fear Survey Schedule-Dental Subscale (CFSS-DS). * Requirement for dental treatment necessitating local anesthesia, such as Class II restorations, pulpotomy, pulpectomy, or extractions. * Systemically healthy children classified as ASA I or ASA II. * Voluntary participation of both the child and the parent, with written informed consent obtained from the parent. * Body weight between 15 and 30 kg, ensuring that the 3-kg weighted blanket corresponds to 10-20% of the child's body weight. Exclusion Criteria: * Children with a CFSS-DS score of 38 or lower. * Presence of intellectual or developmental disabilities. * Presence of visual or hearing impairments. * Presence of neurodevelopmental or neurological disorders, such as epilepsy. * Acute or chronic respiratory diseases. * Neuromuscular or orthopedic conditions that may pose a risk during the use of the weighted blanket. * History of dizziness, nausea, or vertigo associated with virtual reality use. * Refusal of the specific interventions, namely VR glasses or the weighted blanket, by the child or the parent.
Where it's running
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Bezm-i Alem Vakif University, Faculty of Dentistry, Department of Pediatric Dentistry
Istanbul, Fatih, Turkey (Türkiye) Recruiting
Study contacts
- Principal investigator: Mustafa Sarp Kaya, Associate Professor — Bezm-i Alem Vakif University, Faculty of Dentistry, Department of Pediatric Dentistry
- Study coordinator: Ayşe Evirken, DDS
- Email: ayse.evirken@bezmialem.edu.tr
- Phone: +90 543 927 76 86
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.