CClinicalTrials.gg
CompletedNCT07536828Updated Apr 22, 2026

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

An interventional study of Music intervention 1 and Music intervention 2 in Dental Anxiety, Pediatric Dental Patients and Dental Procedures, sponsored by Nigde Omer Halisdemir University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 6 Years to 9 Years. Per ClinicalTrials.gov, last updated 2026-04-22.

Sponsored by Nigde Omer Halisdemir University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled May 2025, registered Apr 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
6 Years to 9 Years
Sex
All
01

Study 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.

02

Conditions studied

  • 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
03

In context

Lead sponsor

Nigde Omer Halisdemir University is the lead sponsor of 89 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 9 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
90 participants (actual)

Study arms

  • 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

  • Experimental
    Patient-Selected Music

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

    Other: Music intervention 2

Interventions

  • OtherMusic 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.

  • OtherMusic 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.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Immediately before and after the procedure

  2. Pulse Rate

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

    Time frame: Immediately before and after the procedure

07

Study locations

1 site
  • Niğde Ömer Halisdemir University Faculty of Dentistry
    Niğde, 51100, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07536828
Lead sponsor
Nigde Omer Halisdemir University
Responsible party
Sponsor
First posted
Apr 17, 2026
Start date
May 24, 2025
Primary completion
Jan 20, 2026
Completion
Feb 27, 2026
Last update
Apr 22, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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