Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 7:30 AM
Study NCT ID:
NCT07350993
Status:
COMPLETED
Last Update Posted:
2026-01-20
First Post:
2025-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Music on Dental Anxiety in Children: Turkish Validation of the CEDAM
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study used a parallel-group design with two groups: a music intervention group and a control group. Participants in the intervention group listened to classical instrumental music during dental treatment, while the control group received treatment without music.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2025-02-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-01-09', 'studyFirstSubmitDate': '2025-12-17', 'studyFirstSubmitQcDate': '2026-01-09', 'lastUpdatePostDateStruct': {'date': '2026-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Children's Anxiety Meter-State (CAM-S) Score", 'timeFrame': 'Baseline (5 minutes before start of the dental procedure), intra-procedural (immediately after administration of local anesthesia), and post-procedural (5 minutes after completion of the dental procedure)', 'description': 'Description: A projective measurement tool consisting of a thermometer-like scale with 10 horizontal lines. The scale evaluates state anxiety levels. Scores range from 1 to 10, where higher scores indicate higher levels of anxiety.\n\nUnit of Measure: CAM-S score'}, {'measure': "Children's Emotional Manifestation Scale (CEMS) Score", 'timeFrame': 'Periprocedural (from seating in the dental chair to completion of the dental procedure)', 'description': 'Description: An observational behavioral assessment tool that evaluates five main categories: facial expression, vocalization, activity, interaction, and cooperation. Each category is rated on a 5-point scale. Total scores range from 5 to 25, where higher scores indicate higher levels of behavioral anxiety.\n\nUnit of Measure: CEMS score'}, {'measure': "Children's Experiences of Dental Anxiety Measure (CEDAM-8) Score", 'timeFrame': 'Baseline (5 minutes before start of the dental procedure) and post-procedural (5 minutes after completion of the dental procedure)', 'description': 'Description: A psychometric tool based on cognitive-behavioral therapy. It consists of 8 questions assessing thoughts, behaviors, physical symptoms, and feelings related to dental anxiety. Responses are recorded on a 3-point Likert scale. Total scores range from 8 to 24, where higher scores indicate greater dental anxiety.\n\nUnit of Measure: CEDAM-8 score'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Behavior guidance', 'Dental anxiety', 'Validity', 'Reliability', 'Music'], 'conditions': ['Dental Anxiety']}, 'descriptionModule': {'briefSummary': "The study will consist of two phases. In the first phase, the validity and reliability of the CEDAM scales will be assessed in children aged 9-16 years using item analysis, content and construct validity, internal consistency, and test-retest reliability.\n\nIn the second phase, the effect of music will be evaluated in a randomized controlled trial involving children aged 9-12 years. The study will employ a three-session design with progressively increasing procedural invasiveness. In the final session, the control group will receive basic behavior guidance, while the intervention group will additionally listen to music during the dental procedure.\n\nPerioperative anxiety will be assessed using the Children's Anxiety Meter-State (CAM-S), Children's Emotional Manifestation Scale (CEMS), and CEDAM-8. A conceptual model will be used to examine the relationships between music intervention, preoperative anxiety, intraoperative anxiety, and postoperative anxiety.", 'detailedDescription': "The study will be conducted in two sequential phases. In the first phase, the cross-cultural validity and reliability of the Children's Experiences of Dental Anxiety Measure (CEDAM) will be assessed in children aged 9-16 years. In the second phase, a subgroup of children aged 9-12 years will be selected from the Phase 1 sample to participate in a randomized controlled trial evaluating the effect of a music intervention on perioperative dental anxiety. Only children requiring at least a second and third dental appointment will be eligible for Phase 2."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '9 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged 9-16 years\n* Systemically healthy children\n* Native Turkish speakers\n* Written informed consent obtained from both the child and a parent or legal guardian\n\nExclusion Criteria:\n\n* Presence of any mental or physical disability\n* History of psychiatric or developmental disorders\n* Known allergies\n* Use of medications'}, 'identificationModule': {'nctId': 'NCT07350993', 'acronym': 'MUSIC-CEDAM', 'briefTitle': 'Effect of Music on Dental Anxiety in Children: Turkish Validation of the CEDAM', 'organization': {'class': 'OTHER', 'fullName': 'Kutahya Health Sciences University'}, 'officialTitle': 'Evaluation of the Effect of Music on the Management of Dental Anxiety in Children: Turkish Validity and Reliability Study of the CEDAM-A Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'CAKICIAKKOC-DENTALANXIETY'}, 'secondaryIdInfos': [{'id': '2024/05-32', 'type': 'REGISTRY', 'domain': 'Kutahya Health Sciences University Non-Interventional Clinical Research Ethics Committee'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Music Intervention Group', 'description': 'Children will listen to classical music during dental treatment to assess the effect on dental anxiety.', 'interventionNames': ['Behavioral: Music Listening Intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Children will receive dental treatment without any music intervention.'}], 'interventions': [{'name': 'Music Listening Intervention', 'type': 'BEHAVIORAL', 'otherNames': ['Classical Music Listenin'], 'description': 'Children will listen to classical instrumental music through headphones during the dental procedure to reduce anxiety levels.', 'armGroupLabels': ['Music Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43100', 'city': 'Kütahya', 'state': 'Kütahya', 'country': 'Turkey (Türkiye)', 'facility': 'Kütahya Health Sciences University Faculty of Dentistry', 'geoPoint': {'lat': 39.42417, 'lon': 29.98333}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Şevval Çakıcı', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor,DDS', 'investigatorFullName': 'Şevval Çakıcı', 'investigatorAffiliation': 'Kutahya Health Sciences University'}}}}