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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014098', 'term': 'Toothache'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D005157', 'term': 'Facial Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-17', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-27', 'studyFirstSubmitDate': '2026-02-16', 'studyFirstSubmitQcDate': '2026-02-27', 'lastUpdatePostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Dental Anxiety Level Assessed by the Children's Fear Survey Schedule-Dental Subscale (CFSS-DS)", 'timeFrame': 'Immediately before the dental procedure (baseline) and immediately after completion of the dental procedure (same day, periprocedural)', 'description': "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.\n\nHigher scores indicate greater dental anxiety (worse outcome).\n\nThe 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."}, {'measure': 'Physiological Stress Response - Cortisol', 'timeFrame': 'During the dental procedure (at the 10th minute of treatment)', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Pain Perception Assessed by the Wong-Baker FACES Pain Rating Scale', 'timeFrame': 'Immediately after completion of the dental procedure (same day, periprocedural assessment)', 'description': '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.\n\nThe 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:\n\n0 = no pain\n\n10 = worst pain possible\n\nHigher scores indicate greater pain intensity (worse outcome).\n\nPain assessment will be performed immediately after completion of the restorative dental procedure to evaluate the effect of tactile distraction materials on perceived pain.'}, {'measure': 'Physiological Stress Response Assessed by Heart Rate Measurement Using Pulse Oximetry', 'timeFrame': 'Baseline (immediately before the dental procedure), during the dental procedure (periprocedural monitoring), and immediately after completion of the dental procedure (same day assessment)', 'description': '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.\n\nHeart 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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dental Anxiety', 'Distraction Techniques', 'Dental Pain', 'Behavior Management', 'Salivary Cortisol'], 'conditions': ['Dental Anxiety', 'Dental Pain', 'Behavioral Management']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nThis 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.\n\nPsychological 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Children aged 6-10 years requiring restorative dental treatment.\n2. Indication for dental treatment under local anesthesia.\n3. Ability to understand and respond to dental anxiety and pain assessment scales (CFSS-DS and Wong-Baker Faces Scale).\n4. Children classified as ASA I or ASA II.\n5. No prior exposure to the distraction materials used in the study during dental treatment.\n6. Written informed consent obtained from parents or legal guardians.\n\nExclusion Criteria:\n\n1. Presence of systemic diseases or medical conditions affecting stress response or contraindicating routine dental treatment\n2. History of psychiatric, neurological, or developmental disorders that may impair cooperation or communication\n3. Use of medications influencing anxiety, pain perception, heart rate, or cortisol levels\n4. Requirement for sedation or general anesthesia for dental treatment\n5. Acute dental infection or emergency treatment requiring immediate intervention\n6. Refusal of participation by the child or parent/legal guardian'}, 'identificationModule': {'nctId': 'NCT07445594', 'acronym': 'PLAY-DENT', 'briefTitle': 'Effect of Play Dough, Slime, and Plush Toys on Dental Anxiety and Pain in Children During Dental Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Afyonkarahisar Health Sciences University'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '25.DUS.005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Play Dough Distraction Group', 'description': 'Participants used play dough as a tactile distraction during restorative dental treatment under local anesthesia to reduce dental anxiety and pain perception.', 'interventionNames': ['Behavioral: Play Dough Distraction', 'Behavioral: No Distraction (Control)']}, {'type': 'EXPERIMENTAL', 'label': 'Slime Distraction Group', 'description': 'Participants used slime as a tactile distraction during restorative dental treatment under local anesthesia to support anxiety and pain management.', 'interventionNames': ['Behavioral: Slime Distraction', 'Behavioral: No Distraction (Control)']}, {'type': 'EXPERIMENTAL', 'label': 'Plush Toy Distraction Group', 'description': 'Participants held a plush toy as a tactile distraction during restorative dental treatment under local anesthesia.', 'interventionNames': ['Behavioral: Plush Toy Distraction', 'Behavioral: No Distraction (Control)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group (No Distraction)', 'description': 'Participants received restorative dental treatment under local anesthesia without any distraction material.', 'interventionNames': ['Behavioral: No Distraction (Control)']}], 'interventions': [{'name': 'Play Dough Distraction', 'type': 'BEHAVIORAL', 'description': 'Use of play dough as a tactile distraction during pediatric dental treatment to reduce anxiety and pain perception.', 'armGroupLabels': ['Play Dough Distraction Group']}, {'name': 'Slime Distraction', 'type': 'BEHAVIORAL', 'description': 'Use of slime as a tactile distraction during pediatric dental treatment.', 'armGroupLabels': ['Slime Distraction Group']}, {'name': 'Plush Toy Distraction', 'type': 'BEHAVIORAL', 'description': 'Use of a plush toy as a tactile distraction during pediatric dental treatment.', 'armGroupLabels': ['Plush Toy Distraction Group']}, {'name': 'No Distraction (Control)', 'type': 'BEHAVIORAL', 'description': 'Standard restorative dental treatment without distraction material.', 'armGroupLabels': ['Control Group (No Distraction)', 'Play Dough Distraction Group', 'Plush Toy Distraction Group', 'Slime Distraction Group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'özgür Doğan, Assoc prof.', 'role': 'CONTACT', 'email': 'ozgurdogan1984@gmail.com', 'phone': '905052777520'}, {'name': 'Nilay Yılmaz, Research Asisstant', 'role': 'CONTACT', 'email': 'nilay.yilmazz@hotmail.com', 'phone': '+90 537 708 51 37'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Afyonkarahisar Health Sciences University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc Prof.', 'investigatorFullName': 'Özgür Doğan', 'investigatorAffiliation': 'Afyonkarahisar Health Sciences University'}}}}