- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07776860
The Effect of Bubble Machine and Cartoon on Pain and Fear
Bubble Machine-Based Visual Distraction Versus Cartoon-Based Audiovisual During Venipuncture in Preschool Children: A Randomized Controlled Trial
Aim: This study aimed to compare the effects of cartoon-based audiovisual distraction and bubble-machine-based visual distraction on pain and fear during venipuncture in preschool children.
Methods: This randomized controlled trial included 123 children aged 3-6 years who underwent venipuncture between February and April 2026. Participants were randomly assigned to a cartoon-based audiovisual distraction group (n = 41), a bubble-machine-based visual distraction group (n = 41), or a control group (n = 41). Children in the cartoon group watched Oggy Oggy on a tablet, while those in the bubble-machine group were exposed to bubbles generated by an automated bubble machine during venipuncture. The control group received routine care. Pain and fear were assessed by the children, parents, and nurse using the Wong-Baker FACES Pain Rating Scale and Children's Fear Scale.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Menemen
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Izmir, Menemen, Turkey (Türkiye), 35665
- Izmir Bakircay University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participants whose child and parents agreed to participate in the study
- Children who had successful phlebotomy on the first attempt
Exclusion Criteria:
- Children with chronic disease, mental disability, or mental retardation
- Children who had taken analgesics in the last 24 hours
- Children who were hospitalized
- Children who had undergone a surgical procedure
- Children who did not have successful phlebotomy on the first attempt
Study Plan
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 |
|---|---|
|
No Intervention: Control
No attempt was made to the 3-6-year-old child included in this group, during the process when the nurse performed the phlebotomy.
Routine phlebotomy was performed.
Pain and fear of the child during the procedure were evaluated.
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Experimental: Bubble Machine
Children assigned to this group were exposed to bubbles generated by an automated bubble machine during venipuncture.
Researcher operated the bubble machine and continuously generated bubbles within the child's visual field to attract and maintain the child's attention during the procedure.
A child-friendly plastic bubble machine was used, and a tear-free baby shampoo suitable for children was used as the bubble solution.
The device was positioned at an appropriate distance from the child so that it did not interfere with the nurse's access to the venipuncture site.
The bubble machine was operated throughout the venipuncture procedure.
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Implementation of Bubble Machine: It is defined as the use of a device called Bubble Machine.
Children are exposed to bubbles generated by an automated bubble machine during venipuncture.
Researcher operate the bubble machine and generate bubbles within the child's visual field to attract and maintain the child's attention during the procedure.
A child-friendly plastic bubble machine is used, and a tear-free baby shampoo suitable for children was used as the bubble solution.
The device is positioned at an appropriate distance from the child so that it did not interfere with the nurse's access to the venipuncture site.
The bubble machine iss operated throughout the venipuncture procedure.
Pain and fear before and during the procedure are evaluated by the researcher, the nurse, and the child's parent.
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Experimental: Cartoon
Children assigned to this group watched the predetermined Cartoon-Oggy Oggy on a tablet during venipuncture.
The cartoon was selected as an age-appropriate audiovisual distraction and was presented in Turkish.
It contains dynamic, colorful, and music-rich scenes intended to attract and maintain children's attention during the procedure.
Researcher operated the tablet and ensured that the child could comfortably view the cartoon while the nurse performed venipuncture.
The cartoon was played throughout the venipuncture procedure.
|
Implementation of Cartoon: It is defined as the use of a called Oggy Oggy.
Children watch the predetermined Cartoon-Oggy Oggy on a tablet during venipuncture.
The cartoon is selected as an age-appropriate audiovisual distraction and is presented in Turkish.
It contains dynamic, colorful, and music-rich scenes intended to attract and maintain children's attention during the procedure.
Researcher operate the tablet and ensure that the child could comfortably view the cartoon while the nurse performed venipuncture.
The cartoon is played throughout the venipuncture procedure.
Pain and fear before and during the procedure are evaluated by the researcher, the nurse, and the child's parent.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Statistical difference between groups about pain scores
Time Frame: Before and during the procedure, approximately 5-10 minutes
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Description: Implementation of interventions aimed at reducing pain in experimental groups.
Wong-Baker Facial Pain Rating Scale: The Facial Expression Rating Scale is a scale that includes 6 facial expressions and provides a rating between 0-10.
This scale, which does not require words, is a reliable and valid measurement tool in the assessment of acute pain.
A score of 0 indicates no pain and a score of 10 indicates the highest level of pain.
In the scale, it means that as the pain score increases, the pain also increases.
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Before and during the procedure, approximately 5-10 minutes
|
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Statistical difference between groups about fear scores
Time Frame: Before and during the procedure, approximately 5-10 minutes
|
Implementation of interventions aimed at reducing fear in experimental groups.
Children's Fear Scale: This scale includes 5 different facial expressions.
This scale is scored between 0-4 and it is stated to be a reliable and valid measurement tool in the evaluation of fear.
This scale does not require words.
A score of 0 indicates no fear and a score of 4 indicates the highest level of fear.
In the scale, it means that as the fear score increases, the fear also increases.
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Before and during the procedure, approximately 5-10 minutes
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Şeyda Binay Yaz, Associate Professor, Izmir Bakircay University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Bakircay2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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