Effect of Music on Anxiety, Pulse Rate, and Pain During Fissure Sealant Application in Children

April 17, 2026 updated by: Nigde Omer Halisdemir University

''I Chose This Music!" Effect: Comparison of Anxiety, Pulse Rate and Pain During Fissure Sealant Application in Children Between Favorite Songs, Classical Music and Silence

This study aimed to evaluate the effects of music on anxiety, heart rate, and pain perception in children during fissure sealant application, and to compare the effectiveness of clinician-selected and patient-selected music. A total of 90 children aged 6-9 years were included in this split-mouth study. Each child received fissure sealant treatment on three permanent first molars under three different conditions: no music, clinician-selected music, and patient-selected music. Anxiety levels were assessed using the Facial Image Scale (FIS), heart rate was measured with a pulse oximeter, and pain perception was evaluated using the Wong-Baker Pain Scale. Measurements were recorded before and after each procedure. Data were analyzed using paired t-tests and repeated measures ANOVA with Bonferroni correction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Niğde, Turkey (Türkiye), 51100
        • Niğde Ömer Halisdemir University Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Children aged 6-9 years
  2. Children with at least 3 fully erupted permanent first molars
  3. Children requiring pit and fissure sealant application
  4. Children with no previous dental treatment experience
  5. Children without learning disabilities
  6. Children without any systemic diseases

Exclusion Criteria:

  1. Children with any physical or mental disability
  2. Children who have previously experienced any psychological disorder that could affect anxiety measurement
  3. Children who have previously received fissure sealant or any other dental treatment
  4. Children whose permanent first molars have not fully erupted, are carious, or have previously undergone other procedures
  5. Children who were unable to cooperate during the procedure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Condition
Fissure sealant application performed without music.
Experimental: Researcher-Selected Music
Fissure sealant application performed while listening to researcher-selected classical music.
Other: Music intervention 1
Participants listened to a standardized classical music piece (Pachelbel's Canon in D Major) played through a speaker for approximately 5 minutes during the procedure. The volume was kept constant.
Experimental: Patient-Selected Music
Fissure sealant application performed while listening to music chosen by the patient.
Other: Music intervention 2
Participants listened to their preferred music played through a speaker for approximately 5 minutes during the procedure. If the selected music was shorter than 5 minutes, it was replayed to standardize the duration. The volume was kept constant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pulse Rate
Time Frame: Immediately before and after the procedure
The children's pulses were assessed before and after each intervention using a finger pulse oximeter.
Immediately before and after the procedure
Anxiety Level
Time Frame: Immediately before and after the procedure
Anxiety levels of children were assessed using the Facial Image Scale before and after each intervention.The scale was scored by ranging from 1 (most positive emotion) to 5 (most negative emotion).
Immediately before and after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nigde Omer Halisdemir University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 24, 2025

Primary Completion (Actual)

January 20, 2026

Study Completion (Actual)

February 27, 2026

Study Registration Dates

First Submitted

April 10, 2026

First Submitted That Met QC Criteria

April 10, 2026

First Posted (Actual)

April 17, 2026

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 17, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NigdeOHU-FissureMusic

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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