An interventional study of Play Dough Distraction and Slime Distraction in Dental Anxiety, Dental Pain and Behavioral Management, sponsored by Afyonkarahisar Health Sciences University. Not yet recruiting. Open to participants aged 6 Years to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-03.
Sponsored by Afyonkarahisar Health Sciences University · Not applicable, Interventional, and Treatment
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.
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.
142 studies on the registry are indexed under Toothache; 28 are open to participants now.
This study's planned enrollment of 90 is close to the median of 84 across 123 interventional studies indexed under Toothache.
Browse Toothache studies →Afyonkarahisar Health Sciences University is the lead sponsor of 115 studies on the registry; 32 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
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ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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)
Participants held a plush toy as a tactile distraction during restorative dental treatment under local anesthesia.
Behavioral: Plush Toy Distraction · Behavioral: No Distraction (Control)
Participants received restorative dental treatment under local anesthesia without any distraction material.
Behavioral: No Distraction (Control)
Use of play dough as a tactile distraction during pediatric dental treatment to reduce anxiety and pain perception.
Use of slime as a tactile distraction during pediatric dental treatment.
Use of a plush toy as a tactile distraction during pediatric dental treatment.
Standard restorative dental treatment without distraction material.
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)
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)
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)
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)
No study locations are listed for this record.
Plan to share: No — Individual participant data will not be publicly shared due to ethical considerations, patient confidentiality, and institutional data protection policies. Only aggregated and anonymized results are reported in scientific publications.
No publications or documents are linked to this record.
Start is estimated for Feb 2026; primary completion for Jun 2026, 3 months later.
Of 44 non-industry interventional studies with no phase under Toothache, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 15. This study's planned 3 months is below that.
Counting every sponsor, half of 45 studies reached it within 5 months; a quarter within 3 and three quarters within 12.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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