Effect of Play Dough, Slime, and Plush Toys on Dental Anxiety and Pain in Children During Dental Treatment

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-10
SponsorAfyonkarahisar Health Sciences University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Play Dough Distraction

    Behavioral

    Use of play dough as a tactile distraction during pediatric dental treatment to reduce anxiety and pain perception.

  • Slime Distraction

    Behavioral

    Use of slime as a tactile distraction during pediatric dental treatment.

  • Plush Toy Distraction

    Behavioral

    Use of a plush toy as a tactile distraction during pediatric dental treatment.

  • No Distraction (Control)

    Behavioral

    Standard restorative dental treatment without distraction material.

Treatment groups

90 Participants
are divided into 4 treatment groups
Group A: Play Dough Distraction GroupExperimental treatment 2 interventions
Group B: Slime Distraction GroupExperimental treatment 2 interventions
Group C: Plush Toy Distraction GroupExperimental treatment 2 interventions
Group D: Control Group (No Distraction)Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Immediately before the dental procedure (baseline) and immediately after completion of the dental procedure (same day, periprocedural)
2

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.

Time frame
During the dental procedure (at the 10th minute of treatment)

Secondary outcomes

1

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.

Time frame
Immediately after completion of the dental procedure (same day, periprocedural assessment)
2

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.

Time frame
Baseline (immediately before the dental procedure), during the dental procedure (periprocedural monitoring), and immediately after completion of the dental procedure (same day assessment)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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