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Not yet recruiting NCT07445594

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

No phase Interventional Dental Anxiety Dental Pain Behavioral Management

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Play Dough Distraction, Slime Distraction, Plush Toy Distraction, No Distraction (Control).
Who it may be relevant to
Registry conditions: Dental Anxiety, Dental Pain, Behavioral Management. Basic parameters: 6 years — 10 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Evaluation of the Effectiveness of Play Dough, Slime, and Plush Toys on Dental Anxiety, Pain Perception, and Salivary Cortisol Levels in Children During Dental Treatment

Overview

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.

Detailed description

Dental anxiety in children remains a significant challenge in pediatric dentistry, often leading to behavioral management difficulties, delayed treatment, and negative long-term attitudes toward dental care. Non-pharmacological behavioral management strategies, including distraction techniques, are widely recommended to reduce anxiety and improve cooperation during dental procedures. Tactile distraction methods such as play dough, slime, and plush toys may provide sensory engagement that helps shift the child's attention away from dental stimuli; however, comparative evidence regarding their effectiveness remains limited.

This randomized controlled clinical study was designed to evaluate the relative effectiveness of different tactile distraction materials during routine pediatric dental treatment. Children aged 6-10 years requiring restorative dental treatment under local anesthesia were randomly assigned to one of four groups: play dough, slime, plush toy distraction, or a control group without distraction. Standardized clinical procedures were applied to all participants under similar clinical conditions.

Psychological responses were assessed using validated dental anxiety and pain perception scales, while physiological stress responses were monitored using heart rate measurements and salivary cortisol analysis. The study aims to provide evidence on whether simple, low-cost tactile distraction tools can enhance patient comfort, reduce perceived anxiety and pain, and support non-pharmacological behavior management approaches in pediatric dental practice.

Interventions

  • Behavioral Play Dough Distraction
    Use of play dough as a tactile distraction during pediatric dental treatment to reduce anxiety and pain perception.
  • Behavioral Slime Distraction
    Use of slime as a tactile distraction during pediatric dental treatment.
  • Behavioral Plush Toy Distraction
    Use of a plush toy as a tactile distraction during pediatric dental treatment.
  • Behavioral No Distraction (Control)
    Standard restorative dental treatment without distraction material.

Primary outcome measures

  • Dental Anxiety Level Assessed by the Children's Fear Survey Schedule-Dental Subscale (CFSS-DS) [Time frame: Immediately before the dental procedure (baseline) and immediately after completion of the dental procedure (same day, periprocedural)]
  • Physiological Stress Response - Cortisol [Time frame: During the dental procedure (at the 10th minute of treatment)]
Secondary outcome measures (2)
  • Pain Perception Assessed by the Wong-Baker FACES Pain Rating Scale [Time frame: Immediately after completion of the dental procedure (same day, periprocedural assessment)]
  • Physiological Stress Response Assessed by Heart Rate Measurement Using Pulse Oximetry [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)]

Eligibility criteria

Inclusion criteria

  • 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.
  • No prior exposure to the distraction materials used in the study during dental treatment.
  • Written informed consent obtained from parents or legal guardians.

Exclusion criteria

  • 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
  • Acute dental infection or emergency treatment requiring immediate intervention
  • Refusal of participation by the child or parent/legal guardian

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07445594 · 25.DUS.005

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗