About this trial
This study aims to evaluate the effectiveness of tactile distraction materials, including play dough, slime, and plush toys, on dental anxiety, pain perception, and physiological stress responses in children undergoing dental treatment. Ninety children aged 6-10 years receiving restorative dental treatment under local anesthesia were randomly assigned to one of four groups: play dough, slime, plush toy, or control group without distraction. Dental anxiety and pain levels were assessed using validated psychometric scales, while physiological stress responses were evaluated through heart rate monitoring and salivary cortisol measurements. The study seeks to determine whether simple non-pharmacological distraction techniques can improve behavioral cooperation and reduce anxiety and pain perception during pediatric dental procedures. Findings may contribute to the development of child-friendly dental management strategies and enhance the quality of pediatric dental care.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Children aged 6-10 years requiring restorative dental treatment.
Indication for dental treatment under local anesthesia.
Ability to understand and respond to dental anxiety and pain assessment scales (CFSS-DS and Wong-Baker Faces Scale).
Children classified as ASA I or ASA II.
Disqualifiers
Presence of systemic diseases or medical conditions affecting stress response or contraindicating routine dental treatment
History of psychiatric, neurological, or developmental disorders that may impair cooperation or communication
Use of medications influencing anxiety, pain perception, heart rate, or cortisol levels
Requirement for sedation or general anesthesia for dental treatment
Trial design
Parallel
Treatments tested in this trial
Play Dough Distraction
BehavioralUse of play dough as a tactile distraction during pediatric dental treatment to reduce anxiety and pain perception.
Slime Distraction
BehavioralUse of slime as a tactile distraction during pediatric dental treatment.
Plush Toy Distraction
BehavioralUse of a plush toy as a tactile distraction during pediatric dental treatment.
No Distraction (Control)
BehavioralStandard restorative dental treatment without distraction material.
Treatment groups
Trial outcomes
Primary outcomes
Dental Anxiety Level Assessed by the Children's Fear Survey Schedule-Dental Subscale (CFSS-DS)
Dental anxiety will be assessed using the Children's Fear Survey Schedule-Dental Subscale (CFSS-DS). The CFSS-DS is a validated 15-item psychometric questionnaire designed to measure dental fear and anxiety in children. Each item is scored on a 5-point Likert scale (1 = not afraid at all to 5 = very afraid), resulting in a total score ranging from 15 to 75. Higher scores indicate greater dental anxiety (worse outcome). The scale will be administered immediately before the dental treatment session and immediately after completion of the procedure to evaluate the effect of tactile distraction materials on anxiety levels during restorative dental treatment.
Physiological Stress Response - Cortisol
Physiological stress response will be assessed by measuring salivary cortisol levels as a biomarker of stress. Saliva samples will be collected before and after the dental treatment session using standardized collection procedures, and cortisol levels will be analyzed using an enzyme-linked immunosorbent assay (ELISA) method to evaluate the potential effects of tactile distraction materials on stress responses in pediatric dental patients.
Secondary outcomes
Pain Perception Assessed by the Wong-Baker FACES Pain Rating Scale
Pain perception will be evaluated using the Wong-Baker FACES® Pain Rating Scale, a validated visual self-report tool commonly used in pediatric populations to measure subjective pain intensity. The scale consists of six faces corresponding to numerical scores of 0, 2, 4, 6, 8, and 10, resulting in a total score range of 0 to 10, where: 0 = no pain 10 = worst pain possible Higher scores indicate greater pain intensity (worse outcome). Pain assessment will be performed immediately after completion of the restorative dental procedure to evaluate the effect of tactile distraction materials on perceived pain.
Physiological Stress Response Assessed by Heart Rate Measurement Using Pulse Oximetry
Physiological stress response will be assessed by measuring heart rate using pulse oximetry, a non-invasive method commonly used to monitor physiological stress during dental procedures in pediatric patients. Heart rate values will be recorded to evaluate physiological responses associated with dental anxiety, pain perception, and the potential effect of tactile distraction materials during restorative dental treatment.
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Sponsors and contacts
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