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Completed

NCT Number: NCT07776860

The Effect of Bubble Machine and Cartoon on Pain and Fear

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.

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Key information

Conditions

Pain Fear Neurologic Manifestations Nurse Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

3 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

İzmir Bakircay University

Izmir, Menemen, 35665, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Implementation of Bubble Machine

Procedure

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 Cartoon

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.

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Official study title

Bubble Machine-Based Visual Distraction Versus Cartoon-Based Audiovisual During Venipuncture in Preschool Children: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 20, 2026
Registry last updated
Aug 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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