Viewing Study NCT07445594


Ignite Creation Date: 2026-03-26 @ 3:18 PM
Ignite Modification Date: 2026-03-31 @ 7:28 AM
Study NCT ID: NCT07445594
Status: NOT_YET_RECRUITING
Last Update Posted: 2026-03-03
First Post: 2026-02-16
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Effect of Play Dough, Slime, and Plush Toys on Dental Anxiety and Pain in Children During Dental Treatment
Sponsor: Afyonkarahisar Health Sciences University
Organization:

Study Overview

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
Status: NOT_YET_RECRUITING
Status Verified Date: 2026-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: PLAY-DENT
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.
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.

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: