CompletedNot Applicable

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

Turkey (Türkiye)45 participantsStarted 2024-08-01

Plain-language 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.

Who can participate

Age range

7 Years – 10 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 perma…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

pre-treatment and post-treatment cortisol level

Timeframe: Values were measured on the day of treatment.

Trial details

NCT IDNCT07144579

SponsorMersin University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-01

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