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Completed

NCT Number: NCT07536828

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

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.

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Key information

Age range

6 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Niğde Ömer Halisdemir University Faculty of Dentistry

Niğde, 51100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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).

  2. 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.

Sponsors and collaborators

Lead sponsor

Nigde Omer Halisdemir University

Other

Registry information

Official study title

''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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 17, 2026
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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