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

NCT07445594 | Not Yet Recruiting

• 1 other identifier: 25.DUS.005
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Dental Anxiety; Dental Pain; Behavioral Management

Keywords

Dental Anxiety; Distraction Techniques; Dental Pain; Behavior Management; Salivary Cortisol

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

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

Secondary Outcomes (2)

• Pain Perception Assessed by the Wong-Baker FACES Pain Rating Scale

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

• Physiological Stress Response Assessed by Heart Rate Measurement Using Pulse Oximetry

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

Study Arms (4)

Play Dough Distraction Group

EXPERIMENTAL

Participants used play dough as a tactile distraction during restorative dental treatment under local anesthesia to reduce dental anxiety and pain perception.

Behavioral: Play Dough Distraction; Behavioral: No Distraction (Control)

Slime Distraction Group

EXPERIMENTAL

Participants used slime as a tactile distraction during restorative dental treatment under local anesthesia to support anxiety and pain management.

Behavioral: Slime Distraction; Behavioral: No Distraction (Control)

Plush Toy Distraction Group

EXPERIMENTAL

Participants held a plush toy as a tactile distraction during restorative dental treatment under local anesthesia.

Behavioral: Plush Toy Distraction; Behavioral: No Distraction (Control)

Control Group (No Distraction)

PLACEBO COMPARATOR

Participants received restorative dental treatment under local anesthesia without any distraction material.

Behavioral: No Distraction (Control)

Interventions

Play Dough Distraction BEHAVIORAL

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

Play Dough Distraction Group

Slime Distraction BEHAVIORAL

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

Slime Distraction Group

Plush Toy Distraction BEHAVIORAL

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

Plush Toy Distraction Group

No Distraction (Control) BEHAVIORAL

Standard restorative dental treatment without distraction material.

Control Group (No Distraction); Play Dough Distraction Group; Plush Toy Distraction Group; Slime Distraction Group

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Afyonkarahisar Health Sciences University: lead

MeSH Terms

Conditions

Toothache

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Facial Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

özgür Doğan, Assoc prof.

CONTACT

905052777520; ozgurdogan1984@gmail.com

Nilay Yılmaz, Research Asisstant

CONTACT

+90 537 708 51 37; nilay.yilmazz@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof.

Model Details: Participants were randomly assigned to one of four parallel groups: play dough, slime, plush toy distraction, or a control group without distraction. Each participant received only one intervention during restorative dental treatment under local anesthesia, and group comparisons were performed to evaluate the effects of tactile distraction on dental anxiety, pain perception, and physiological stress responses.

Study Record Dates

• First Submitted: February 16, 2026
• First Posted: March 3, 2026
• Study Start: February 17, 2026
• Primary Completion: June 1, 2026
• Study Completion: June 1, 2026
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share