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

NCT07536828 | Completed

• 1 other identifier: NigdeOHU-FissureMusic
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Anxiety; Pediatric Dental Patients; Dental Procedures; Pain Perception; Fissure Sealant

Keywords

Pediatric Dentistry; Auditory Distraction; Pain Measurement; Dental Anxiety; Music Therapy; Pit and Fissure Sealants

Outcome Measures

Primary Outcomes (2)

• Anxiety Level

  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

• Pulse Rate

  The children's pulses were assessed before and after each intervention using a finger pulse oximeter.

  Immediately before and after the procedure

Study Arms (3)

Control Condition

NO INTERVENTION

Fissure sealant application performed without music.

Researcher-Selected Music

EXPERIMENTAL

Fissure sealant application performed while listening to researcher-selected classical music.

Other: Music intervention 1

Patient-Selected Music

EXPERIMENTAL

Fissure sealant application performed while listening to music chosen by the patient.

Other: Music intervention 2

Interventions

Music intervention 1 OTHER

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.

Researcher-Selected Music

Music intervention 2 OTHER

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.

Patient-Selected Music

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Nigde Omer Halisdemir University: lead

Study Sites (1)

Niğde Ömer Halisdemir University Faculty of Dentistry

Niğde, 51100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Van der Woude syndrome

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study was designed as a split-mouth randomized crossover trial in which each participant received all three interventions (control, researcher-selected music, and patient-selected music) in different sequences.

Study Record Dates

• First Submitted: April 10, 2026
• First Posted: April 17, 2026
• Study Start: May 24, 2025
• Primary Completion: January 20, 2026
• Study Completion: February 27, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)