NCT07336719

Brief Summary

This study investigated the effect of showing cartoons or playing music during the procedure on the physiological parameters of pain and fear experienced by children aged 6-12 undergoing tooth extraction treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 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

April 15, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2025

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

January 2, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 13, 2026

Completed
Last Updated

January 13, 2026

Status Verified

January 1, 2026

Enrollment Period

8 months

First QC Date

January 2, 2026

Last Update Submit

January 2, 2026

Conditions

Keywords

anxietydistractiondental extractionpain managementnursing care

Outcome Measures

Primary Outcomes (5)

  • Child Identification Information Form

    This form was created by researchers based on the literature to determine the identifying characteristics (age, gender, type and duration of treatment, etc.) of a child undergoing dental treatment.

    Five minutes before the procedure

  • Physiological Parameter Follow-up Form (Heart rate-min)

    This is a form developed by researchers to assess the pulse and oxygen saturation of a child undergoing treatment.

    Tooth extraction 1 minute ago

  • Physiological Parameter Follow-up Form (oxygen saturation -SpO2%)

    This is a form developed by researchers to assess the pulse and oxygen saturation of a child undergoing treatment.

    Tooth extraction 1 minute ago

  • Wong Baker Facial Pain Rating Scale

    The Wong Baker Facial Rating Scale is one of the scales used to assess pain. This scale consists of six facial expressions, rated from 0 to 10 according to the severity of the pain.

    Tooth extraction 1 minute ago

  • Child Fear Assessment Scale-Dental Subscale (CFSS-DS)

    The CFSS-DS scale consists of 15 questions covering different aspects of dental treatment. It can be used with children aged 4-14 years. It is used to determine children's fear of tooth extraction.

    Tooth extraction 1 minute ago

Secondary Outcomes (7)

  • Physiological Parameter Follow-up Form (Heart rate-min

    5th minute of the process

  • Physiological Parameter Follow-up Form (oxygen saturation -SpO2%)

    5th minute of the process

  • Wong Baker Facial Pain Rating Scale

    5th minute of the process

  • Physiological Parameter Follow-up Form (Heart rate-min)

    1 minute after the procedure

  • Physiological Parameter Follow-up Form (oxygen saturation -SpO2%)

    1 minute after the procedure

  • +2 more secondary outcomes

Study Arms (3)

Experimantal Group: Cartoon Group

EXPERIMENTAL

In this group of 20 children, cartoons were shown during the tooth extraction procedure. Before the procedure began, the child's vital signs (heart rate and blood oxygen level), pain level, and fear level were measured. The child watched their chosen cartoon during the procedure. Vital signs and pain level were measured again during the procedure. One minute after the procedure was completed, the child's vital signs, pain level, and fear level were measured again.

Other: Cartoon viewing app

Experimantal Group: Music Group

EXPERIMENTAL

In this group of 20 children, music was played during the tooth extraction procedure. Before the procedure began, the child's vital signs (heart rate and blood oxygen level), pain level, and fear level were measured. The music chosen by the child was played during the procedure. Vital signs and pain level were measured again during the procedure, and again 1 minute after the procedure was completed.

Other: Music intervention

Control Group

OTHER

The control group consisted of 20 children who underwent the routine procedure. One minute before the procedure, the child's vital signs (heart rate and blood oxygen level), pain level, and fear level were measured. Vital signs and pain level were measured again during the procedure. One minute after the procedure was completed, the child's vital signs, pain level, and fear level were measured again.

Other: control group

Interventions

Before starting the study, a compilation of children's favorite cartoons specific to their age group was prepared. Based on randomization, children in this group were asked before the procedure which cartoon they would like to watch. During the procedure, a tablet was placed in a position where the child could easily see it. The cartoon started being shown one minute before the procedure. Uninterrupted viewing was ensured throughout the procedure.

Experimantal Group: Cartoon Group

Before starting the study, a list of children's favorite music specific to their age group was compiled. Children in this group were randomly assigned to listen to which music from this list before the procedure. Wireless headphones were placed on the child before the procedure. Music began playing one minute prior to the procedure. The child was allowed to listen to music continuously throughout the procedure.

Experimantal Group: Music Group

No interventions were performed on the children in this group outside of routine practice.

Control Group

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Be between 6 and 12 years of age,
  • Have no systemic, neurological, or chronic diseases,
  • Agree to sit in the patient chair (according to the Frankl scale: 2, 3, or 4),
  • Have no mental or neurological problems,
  • Understand and speak Turkish,
  • Have an indication for tooth extraction
  • Willingness to participate in the study,
  • No visual or auditory impairments

You may not qualify if:

  • Being a foreign national,
  • Not wanting to participate in the study,
  • Not agreeing to sit in the patient chair (1 on the Frankl scale)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Selcuk University

Konya, 42130, Turkey (Türkiye)

Location

Related Publications (1)

  • Koller D, Goldman RD. Distraction techniques for children undergoing procedures: a critical review of pediatric research. J Pediatr Nurs. 2012 Dec;27(6):652-81. doi: 10.1016/j.pedn.2011.08.001. Epub 2011 Oct 13.

MeSH Terms

Conditions

AgnosiaAnxiety Disorders

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Sibel Kucukoglu

    Selcuk University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The G\*Power 3.1.9.2 program was used to calculate the sample size for the study. The G\*Power 3.1.9.6 program was used for the prior sample size calculation. Anticipating potential losses, the sample size was increased by approximately 20%, and the study was planned to be conducted with 20 children in each group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

January 2, 2026

First Posted

January 13, 2026

Study Start

April 15, 2025

Primary Completion

December 15, 2025

Study Completion

December 15, 2025

Last Updated

January 13, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations