PainNCT07776860
The Effect of Bubble Machine and Cartoon on Pain and Fear
A study testing Implementation of Bubble Machine and Implementation of Cartoon in people with Pain and Fear, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- What is being tested?
- Implementation of Bubble Machine and Implementation of Cartoon
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Feb 2026to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Participants whose child and parents agreed to participate in the study
- Children who had successful phlebotomy on the first attempt
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
İzmir Bakircay University
Izmir, Menemen, 35665
About this study
Official title: 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.
- Being tested
- Implementation of Bubble Machine, Implementation of Cartoon
- Keywords
- Venipuncture, Pain, Fear, Distraction, Audiovisual Aids
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation of Bubble MachineProcedure or surgery
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.
Implementation of CartoonProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Bubble Machine | Experimental | 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. Receives: Procedure: Implementation of Bubble Machine |
| Cartoon | Experimental | 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. Receives: Procedure: Implementation of Cartoon |
| Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Statistical difference between groups about pain scores
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.
Measured: Before and during the procedure, approximately 5-10 minutes
Statistical difference between groups about fear scores
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.
Measured: Before and during the procedure, approximately 5-10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start16 Feb 2026
- Primary completion17 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study was a randomized controlled experimental study.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şeyda BİNAY YAZ, Izmir Bakircay University
- Investigators
- Şeyda Binay Yaz, Associate Professor, Principal investigator, Izmir Bakircay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07776860
- Sponsor's protocol ID
- Bakircay2
- Status last verified
- Apr 2026
- First submitted
- 17 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bubble Machine-Based Visual Distraction Versus Cartoon-Based Audiovisual During Venipuncture in Preschool Children: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07776860
- Acronym / sponsor ID
- Bakircay2
- Keywords
- Venipuncture, Pain, Fear, Distraction, Audiovisual Aids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 16 Feb 2026 (actual)
- Primary completion
- 17 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 20 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- The study was a randomized controlled experimental study.
| Arm | Type | Receives |
|---|---|---|
| Bubble Machine | Experimental | Procedure: Implementation of Bubble MachineChildren 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. |
| Cartoon | Experimental | Procedure: Implementation of CartoonChildren 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. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Participants whose child and parents agreed to participate in the study
- Children who had successful phlebotomy on the first attempt
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implementation of Bubble MachineImplementation 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. | Procedure or surgery | Bubble Machine |
| Implementation of CartoonImplementation 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. | Procedure or surgery | Cartoon |
Primary outcome
Statistical difference between groups about pain scores
Time frame: Before and during the procedure, approximately 5-10 minutes
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Şeyda Binay Yaz, Associate Professor principal investigator
Izmir Bakircay University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation of Bubble Machine and Implementation of Cartoon in people with Pain and Fear, run by Ege University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Statistical difference between groups about pain scores (time frame: Before and during the procedure, approximately 5-10 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.