- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07336719
The Effect of Cartoon and Music Applications on Dental Pain (Pain Relief)
January 2, 2026 updated by: Sibel Küçükoğlu, Selcuk University
The Effect of Showing Cartoons and Playing Music During Dental Treatment on Pain and Treatment Anxiety in Children: A Randomized Controlled Trial
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.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Pediatric patients are frequently exposed to medical procedures that can cause pain and anxiety.
While pharmacological interventions may be used, distraction is a simple and effective technique that diverts children's attention away from distressing stimuli.
Distraction is a non-pharmacological pain management technique widely used by healthcare professionals during procedures to reduce pain and distress.
It is based on the assumption that by shifting the child's attention to something interesting, their ability to pay attention to painful stimuli is inhibited, thereby reducing pain, distress, and anxiety.
However, there are no published studies examining the effect of watching cartoons, listening to music, and the tell-show-do approach during tooth extraction on the physiological parameters, pain, and anxiety of children aged 6-12 years.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Konya, Turkey (Türkiye), 42130
- Selcuk University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Being a foreign national,
- Not wanting to participate in the study,
- Not agreeing to sit in the patient chair (1 on the Frankl scale)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimantal Group: Cartoon Group
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.
|
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.
|
|
Experimental: Experimantal Group: Music Group
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.
|
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.
|
|
Other: Control Group
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.
|
No interventions were performed on the children in this group outside of routine practice.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Child Identification Information Form
Time Frame: Five minutes before the procedure
|
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.
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Five minutes before the procedure
|
|
Physiological Parameter Follow-up Form (Heart rate-min)
Time Frame: Tooth extraction 1 minute ago
|
This is a form developed by researchers to assess the pulse and oxygen saturation of a child undergoing treatment.
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Tooth extraction 1 minute ago
|
|
Physiological Parameter Follow-up Form (oxygen saturation -SpO2%)
Time Frame: Tooth extraction 1 minute ago
|
This is a form developed by researchers to assess the pulse and oxygen saturation of a child undergoing treatment.
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Tooth extraction 1 minute ago
|
|
Wong Baker Facial Pain Rating Scale
Time Frame: Tooth extraction 1 minute ago
|
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.
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Tooth extraction 1 minute ago
|
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Child Fear Assessment Scale-Dental Subscale (CFSS-DS)
Time Frame: Tooth extraction 1 minute ago
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physiological Parameter Follow-up Form (Heart rate-min
Time Frame: 5th minute of the process
|
This is a form developed by researchers to assess the pulse and oxygen saturation of a child undergoing treatment.
|
5th minute of the process
|
|
Physiological Parameter Follow-up Form (oxygen saturation -SpO2%)
Time Frame: 5th minute of the process
|
This is a form developed by researchers to assess the pulse and oxygen saturation of a child undergoing treatment.
|
5th minute of the process
|
|
Wong Baker Facial Pain Rating Scale
Time Frame: 5th minute of the process
|
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.
|
5th minute of the process
|
|
Physiological Parameter Follow-up Form (Heart rate-min)
Time Frame: 1 minute after the procedure
|
This is a form developed by researchers to assess the pulse and oxygen saturation of a child undergoing treatment.
|
1 minute after the procedure
|
|
Physiological Parameter Follow-up Form (oxygen saturation -SpO2%)
Time Frame: 1 minute after the procedure
|
This is a form developed by researchers to assess the pulse and oxygen saturation of a child undergoing treatment.
|
1 minute after the procedure
|
|
Wong Baker Facial Pain Rating Scale
Time Frame: 1 minute after the procedure
|
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.
|
1 minute after the procedure
|
|
Child Fear Assessment Scale-Dental Subscale (CFSS-DS)
Time Frame: 1 minute after the procedure
|
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 a child's fear of tooth extraction.
|
1 minute after the procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Sibel Kucukoglu, Selcuk University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 15, 2025
Primary Completion (Actual)
December 15, 2025
Study Completion (Actual)
December 15, 2025
Study Registration Dates
First Submitted
January 2, 2026
First Submitted That Met QC Criteria
January 2, 2026
First Posted (Actual)
January 13, 2026
Study Record Updates
Last Update Posted (Actual)
January 13, 2026
Last Update Submitted That Met QC Criteria
January 2, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Mental Disorders
- Neurobehavioral Manifestations
- Perceptual Disorders
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Anxiety Disorders
- Agnosia
- Investigative Techniques
- Epidemiologic Research Design
- Epidemiologic Methods
- Research Design
- Methods
- Control Groups
Other Study ID Numbers
- 02-SU.01-2026SA/2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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