Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 3:18 PM
NCT ID:
NCT07350993
Brief Summary:
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.
In 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.
Perioperative 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.
Detailed Description:
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.
Study:
NCT07350993
Study Brief:
Protocol Section:
NCT07350993