N
← Back to Search
Sponsored

Accelerate Your Clinical Trial Recruitment

Reach thousands of high-intent patients matching your specific inclusion criteria.

Start Campaign
RECRUITING Not applicable ClinicalTrials.gov

Effect of Buzzy and Virtual Reality on Children Undergoing Venous Procedures

Sponsor: Bandırma Onyedi Eylül University • ClinicalTrials.gov ID: NCT07882602

Registry updated: 2026-10-20
Ad

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Check Eligibility →

Description

Throughout the diagnostic and treatment process, pediatric patients are subjected to invasive procedures-such as peripheral intravenous catheterization (PIVC)-that cause pain, stress, fear, and anxiety. PIVC is one of the most commonly used procedures in modern medicine. This method is used for a variety of procedures, including intravenous fluid support, continued medication administration, monitoring of hemodynamic parameters, and the provision of total parenteral nutrition. However, the narrow diameter of veins in children and the fact that their vascular structure is not yet fully developed make the PIVC procedure more challenging compared to adults and often result in unsuccessful attempts. Particularly in time-critical units such as the emergency department, multiple failed attempts can lead to prolonged procedure times and various complications. Inadequate vascular access can lead to negative emotional reactions in children-such as pain, fear, and anxiety-as well as disruptions in the treatment process, tissue damage, an increased need for diagnosis and treatment, an increased workload for healthcare providers, and higher healthcare costs. Furthermore, repeat procedures lead to increased parental anxiety and a decline in trust in healthcare services. Therefore, when approaching children within the framework of the principle of atraumatic care, the goal should not be the complete elimination of pain, but rather the reduction of the duration and intensity of exposure to it. In this context, the proposed study aims to conduct a comparative analysis of the effects of distractions and technological interventions used during invasive procedures on children and their parents. By integrating these methods-which have been evaluated in only a limited number of studies in the literature-into nursing care, the study aims to develop evidence-based recommendations for improving patient comfort and reducing traumatic experiences. Research Hypotheses H0: There is no difference between the groups in terms of pain, fear, anxiety, procedure duration, and anxiety scores associated with central venous catheterization. H1a: There is a difference between the groups in pain scores in children associated with the PIVC procedure. H1b: There is a difference between the groups in fear scores in children associated with the PIVC procedure. H1c: There is a difference between the groups in terms of anxiety scores in children associated with the PIVC procedure. H1d: There is a difference between the groups in terms of worry scores in parents associated with the PIVC procedure. H1e: There is a difference between the groups in terms of procedure durations associated with the PIVC procedure. Working groups: Vein imaging device + virtual reality headset group Ven imaging device + Buzzy group Vein imaging device Data Collection Tools The study will use the Demographic Information Form, the Wong-Baker Facial Expression Rating Scale, the Children's Fear and Anxiety Scale, and the State-Trait Anxiety Inventory (STAI) to measure parental anxiety, and data will be collected while taking the duration of the procedure into account.

Interventions

  • Vein-imaging device + virtual reality headset group (Behavioral)
    Patients and families will be informed that the Qualmedi MT-600 Vein-Finder is used to visualize veins; the device will identify the vein for peripheral intravenous catheter (PIVC) insertion. Three minutes before and after the procedure, parents will complete the Descriptive Information Form and State-Trait Anxiety Inventory (STAI), and children will complete the Wong-Baker FACES Pain Rating Scale and the Children's Fear and Anxiety Scales. The child will be introduced to a white smartphone-compatible "VR BOX 3.0" headset, which will be fitted 60 seconds before the procedure while an Amazon video is played. Disposable covers will be applied to facial-contact areas, and the outer surfaces and screen will be disinfected. Children who wish to remove the headset will be withdrawn. Immediately after the headset is fitted, the nurse will perform catheterization. Primary endpoint: voluntary headset removal; secondary: catheterization success and duration; tertiary: pain, fear, anxiety.
  • Vein-imaging device + Buzzy group (Behavioral)
    Patients and families will be informed that the Qualmedi MT-600 Vein-Finder is used to visualize veins; the device will identify the vein for peripheral intravenous catheter (PIVC) insertion. Buzzy® (MMJ Labs, Atlanta, USA), a reusable device combining cold and high-frequency vibration to reduce procedural pain and distract attention, will be used. Its frozen wing-shaped ice pack is inserted before use and wiped with 70% alcohol afterward. Three minutes before and after the procedure, parents will complete the Descriptive Information Form and STAI, and children the Wong-Baker FACES Pain Rating Scale and Children's Fear and Anxiety Scales. Sixty seconds before the procedure, Buzzy will be placed on the antecubital fossa; the nurse will then slide it about 3 cm proximally, apply the tourniquet, and perform catheterization. Primary endpoint: refusal of Buzzy; secondary: success and duration; tertiary: pain, fear, anxiety, and parental anxiety at 3 minutes.

Eligibility criteria

Inclusion Criteria: * The child must be between the ages of 7 and 12. * Written consent from the parents indicating their voluntary participation in the study. * The child must have a fever (\>37.5°C). Exclusion Criteria: * Parents wishing to withdraw from the study at any stage * The patient having taken antipyretic or analgesic medications prior to the PIVC procedure * The presence of severe dehydration

Conditions

Fever Children

Locations

  • Karacabey state hospital — Bursa, Turkey (Türkiye)
Sponsored

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record