Multisensory Approaches for Managing Pediatric Dental Anxiety
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-9
SponsorBezmialem Vakif University
About this trial
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
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Basic Behavior Guidance
Other interventionTraditional non-pharmacological behavior management techniques, including the "Tell-Show-Do" method, positive reinforcement, and distraction through verbal communication, will be used as a standard protocol.
Deep Pressure Stimulation
Other interventionA 3 kg weighted blanket will be placed over the participant's body during the dental treatment. This intervention aims to provide deep pressure stimulation to promote relaxation and decrease behavioral stress responses.
Virtual Reality Distraction
DeviceThe participant will wear a Virtual Reality headset during the dental procedure. Audio-visual content specifically selected for pediatric distraction will be played to divert the child's attention away from dental stimuli and reduce anxiety.
Treatment groups
60 Participants
are divided into 4 treatment groupsGroup A: Control GroupActive comparator 1 intervention
Group B: Virtual Reality GroupExperimental treatment 1 intervention
Group C: Weighted Blanket GroupExperimental treatment 1 intervention
Group D: Combined Intervention GroupExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Children's Fear Survey Schedule-Dental Subscale (CFSS-DS) Score
Dental fear and anxiety will be assessed using the Children's Fear Survey Schedule-Dental Subscale (CFSS-DS). The total score ranges from 15 to 75, with higher scores indicating greater dental fear and anxiety.
Time frame
During the dental examination session, before dental treatment.2
Facial Image Scale (FIS) Score
Dental anxiety will be assessed using the Facial Image Scale (FIS), a 5-point facial image scale ranging from 1 to 5, with higher scores indicating greater dental anxiety. FIS scores will be recorded at three time points: immediately before dental treatment, immediately after local anesthetic injection, and immediately after completion of dental treatment.
Time frame
Immediately before dental treatment, immediately after local anesthetic injection, and immediately after completion of dental treatment.3
Frankl Behavior Rating Scale Score
Child behavior and cooperation during dental treatment will be assessed using the Frankl Behavior Rating Scale, which categorizes behavior into four levels ranging from definitely negative to definitely positive.
Time frame
Immediately before dental treatment ande immediately after dental treatment.4
FLACC Behavioral Pain Assessment Score
Pain-related behavioral responses will be assessed using the FLACC (Face, Legs, Activity, Cry, Consolability) scale. The total score ranges from 0 to 10, with higher scores indicating greater pain-related behavioral response. Assessment will be performed by an independent evaluator blinded to group allocation using standardized video recordings.
Time frame
Immediately before dental treatment, immediately after local anesthetic injection, and immediately after completion of dental treatment.Sponsors and contacts
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Source ClinicalTrials.gov