NCT07602075

Brief Summary

This study aims to evaluate dental anxiety and stress levels in children receiving regular piano training compared with children without piano training during preventive dental treatment. A total of 80 children aged 7-11 years, including 40 children receiving piano education and 40 controls, were included in the study. All participants underwent fissure sealant application using the Tell-Show-Do behavioral guidance technique. Dental anxiety was assessed before and after treatment using the Modified Child Dental Anxiety Scale-Faces Version (MCDASf), Facial Image Scale (FIS), and physiological parameters including pulse rate, blood pressure, oxygen saturation, and body temperature. Stress levels were evaluated using the PeSSKi scale. The study investigates whether regular piano education contributes to reduced dental anxiety and stress responses in pediatric dental patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2026

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 10, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 22, 2026

Completed
Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

8 months

First QC Date

May 10, 2026

Last Update Submit

May 15, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Dental Anxiety Level Measured by the Modified Child Dental Anxiety Scale-Faces Version

    Dental anxiety levels during preventive dental treatment will be assessed using the Modified Child Dental Anxiety Scale-Faces Version (MCDASf). The MCDASf score ranges from 8 to 40 points, with higher scores indicating greater dental anxiety.

    Before and immediately after fissure sealant application

  • Dental Anxiety Level Measured by the Facial Image Scale

    Dental anxiety levels during preventive dental treatment will be assessed using the Facial Image Scale (FIS). The FIS score ranges from 1 to 5 points, with higher scores indicating greater dental anxiety.

    Before and immediately after fissure sealant application

Secondary Outcomes (6)

  • Stress Level Measured by the Pediatric Emotional Stress Scale in Kindergarten Intervention (PeSSKI)

    Before and immediately after fissure sealant application

  • Pulse Rate During Preventive Dental Treatment

    Before and immediately after fissure sealant application

  • Systolic Blood Pressure

    Before and immediately after fissure sealant application.

  • Diastolic Blood Pressure

    Before and immediately after fissure sealant application

  • Oxygen Saturation

    Before and immediately after fissure sealant application

  • +1 more secondary outcomes

Study Arms (2)

Regular Piano Training Group

EXPERIMENTAL

Children aged 7-11 years who received regular piano training and underwent fissure sealant application.

Behavioral: Regular Piano Training

Control Group

OTHER

Children aged 7-11 years without regular piano training who underwent fissure sealant application.

Other: No Piano Training

Interventions

Regular piano education received by children prior to preventive dental treatment. Children in this group had ongoing piano training and were evaluated for dental anxiety, stress levels, and physiological responses during fissure sealant application using the Tell-Show-Do technique.

Regular Piano Training Group

Children without regular piano training who underwent preventive dental treatment and fissure sealant application using the Tell-Show-Do technique. Dental anxiety, stress levels, and physiological parameters were evaluated before and after treatment.

Control Group

Eligibility Criteria

Age7 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children aged between 7 and 11 years
  • Patients attending the Department of Pediatric Dentistry, Faculty of Dentistry,
  • Recep Tayyip Erdoğan University, and participants invited from two different art schools
  • Voluntary participation in the study
  • Presence of fissure sealant indication in the mandibular permanent first molars
  • Systemically healthy children (ASA I) with no known history of allergy
  • No hearing impairment
  • Cognitive ability sufficient to understand and answer questionnaire items
  • Cooperative behavior classified as "Positive" or "Definitely Positive" according to the Frankl Behavior Rating Scale

You may not qualify if:

  • Presence of any systemic disease or history of allergy
  • Children classified as "Negative" or "Definitely Negative" according to the Frankl Behavior Rating Scale
  • Active psychological and/or psychiatric treatment
  • Physical or mental disability preventing communication or questionnaire completion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Recep Tayyip Erdoğan University

Merkez, Rize Province, 53020, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

May 10, 2026

First Posted

May 22, 2026

Study Start

August 1, 2025

Primary Completion

March 25, 2026

Study Completion

April 1, 2026

Last Updated

May 22, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations