Effect of Music on Pain, Anxiety, and Behavior in Anxious Children During Molar Restorations

NCT ID: NCT07144579

Last Updated: 2025-08-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2025-08-01

Brief Summary

Managing the child's behavior and anxiety is critical for the treatment in pediatric dentistry to be successful. Behavior management techniques aim to reduce the need for excessive and potentially unsafe medication use. Audio distraction is a non-intrusive distraction technique in which patients listen to music or a story during a stressful procedure. The success of the vocal distraction technique has been validated in medical settings, but insufficient literature exists to measure the potency of this technique for the pediatric population. The aim of this study is to reveal the effects of listening to music during dental treatment on the anxiety of 45 patients aged 7-10 years with dentist anxiety who applied to Mersin University Faculty of Dentistry Pediatric Dentistry clinic in 2024. The compliance of children who apply for routine examination and treatment by the researcher will be evaluated according to the Children's Fear Survey Schedule-Dental Subscale (CFSS-DS), and if they score between 32-38, they will be invited to the study. Patients who agree to participate in the study will be divided into 3 groups.In the control group consisting of 15 pediatric patients, routine treatment will be performed without any distraction. In the 2nd group (intervention group consisting of 15 people), the patient will receive routine treatment accompanied by music by opening Mozart's Sonata for Two Pianos in D Major, K.448 on the computer in the clinic. In the 3rd group (intervention group consisting of 15 participants), patients will be asked what music they want to listen to and will be played music accordingly. Later, in order to evaluate the effect of the music listened to during dental treatment on anxiety, measurements will be taken at the routine appointment to show the anxiety state before, after and during the treatment. These measurements were determined as a result of literature review as the Children's Fear Research Program Dental Subscale (CFSS-DS), blood pressure, pulse, body temperature, oxygen saturation and salivary cortisol levels. Cortisol levels will be measured using the Cortisol Salivary Enzyme Linked Immunosorbent Assay (ELISA) Test Kit.

Conditions

Healhty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Control

no audio distraction

Group Type: NO_INTERVENTION

No interventions assigned to this group

Mozart Music Group

"Mozart - Sonata for Two Pianos in D, K. 448" music was played

Group Type: ACTIVE_COMPARATOR

Mozart music group

Intervention Type: BEHAVIORAL

The experimental group was played Mozart - Sonata for Two Pianos in D, K. 448 on the clinic computer.

Preferred music group

The patient's requested music was played

Group Type: ACTIVE_COMPARATOR

preferred music group

Intervention Type: BEHAVIORAL

The experimental group was made to listen to their preferred music in the clinic.

Interventions

Mozart music group

The experimental group was played Mozart - Sonata for Two Pianos in D, K. 448 on the clinic computer.

Intervention Type: BEHAVIORAL

preferred music group

The experimental group was made to listen to their preferred music in the clinic.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Patients who applied to the Department of Pediatric Dentistry, Faculty of Dentistry, Mersin University, between 01.08.2024 and 01.08.2025
• Patients with moderate anxiety, scoring 32-38 points on the dental subscale of the Children's Fear Survey Schedule - Dental Subscale (CFSS-DS)
• Voluntary participation of both the child and the parent in the study
• Patients with no previous dental experience
• Absence of any urgent dental condition requiring immediate intervention (e.g., pain, abscess, fistula)
• Systemically healthy patients
• No previous dental treatment experience
• Signed informed consent form by the parent/guardian
• Children aged between 7 and 10 years
• Patients with dentinal caries in the mandibular permanent first molar
• Patients whose treatment duration is expected to be approximately 30-45 minutes

Exclusion Criteria

• Child and/or parent unwilling to participate in the study
• Failure to sign the informed consent form/written consent form
• Presence of any systemic disease
• Patients with low or high anxiety levels, scoring below 32 or above 38 on the dental subscale of the Children's Fear Survey Schedule - Dental Subscale (CFSS-DS)
• Patients with previous dental experience
• Children younger than 7 years or older than 10 years
• Caries in the mandibular permanent first molar requiring pulp therapy
• Presence of abscess or inflammation originating from the mandibular permanent first molar
• Absence of caries in the mandibular permanent first molar
• Teeth in which a dental dam cannot be applied

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mersin University

OTHER

Sponsor Role: lead

Responsible Party

Elif UĞURBEKLER HÜNDÜ

Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mersin Universty

Mersin, yenişehir, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

MersinU-DHF-EUH-01

Identifier Type: -

Identifier Source: org_study_id