NCT07848542 Multisensory Approaches for Managing Pediatric Dental Anxiety
| NCT ID | NCT07848542 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Bezmialem Vakif University |
| Condition | Pediatric Dental Anxiety |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-08-19 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2026-08-19 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this prospective, randomized, single-blind clinical study is to evaluate and compare the effectiveness of distraction using virtual reality (VR) glasses and deep-pressure stimulation using weighted blankets on dental anxiety, cooperation, and pain perception in school-aged children. The study focuses on children aged 5-9 years with high dental anxiety (CFSS-DS score ≥39) who require dental procedures involving local anesthesia, such as Class II restorations, pulpotomy, or extractions. Participants will be randomly assigned to four groups: a control group receiving standard behavior guidance, a VR group, a weighted blanket group, and a combined group using both VR and weighted blankets. The study aims to determine the effects of these non-pharmacological, non-invasive, sensory-based interventions on children's clinical experience and physiological parameters.
Eligibility 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.
Contact & Investigator
Mustafa Sarp Kaya, Associate Professor
PRINCIPAL INVESTIGATOR
Bezm-i Alem Vakif University, Faculty of Dentistry, Department of Pediatric Dentistry
Frequently Asked Questions
Who can join the NCT07848542 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, up to 9 Years, studying Pediatric Dental Anxiety. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07848542 currently recruiting?
Yes, NCT07848542 is actively recruiting participants. Contact the research team at ayse.evirken@bezmialem.edu.tr for enrollment information.
Where is the NCT07848542 trial being conducted?
This trial is being conducted at Istanbul, Turkey (Türkiye).
Who is sponsoring the NCT07848542 clinical trial?
NCT07848542 is sponsored by Bezmialem Vakif University. The principal investigator is Mustafa Sarp Kaya, Associate Professor at Bezm-i Alem Vakif University, Faculty of Dentistry, Department of Pediatric Dentistry. The trial plans to enroll 60 participants.
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