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โ† Trials
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Multisensory Approaches for Managing Pediatric Dental Anxiety

RecruitingNAAges 5 Years - 9 YearsAllBezmialem Vakif University
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In plain words

What the trial is, and whether it could suit you

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 โ‰ฅ39) 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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Basic Behavior Guidance
  • Deep Pressure Stimulation
  • Virtual Reality Distraction
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Where

1 site
Bezm-i Alem Vakif University, Faculty of Dentistry, Department of Pediatric Dentistry
Istanbul, Turkey (Tรผrkiye)
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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