The Effect of Buzzy and VR on Procedure Duration, Pain, Fear, and Parental Anxiety in Children Undergoing Venous Imaging
| Registry | NCT07882602 |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, supportive care |
| Enrollment | 105 (Estimated) |
| Sponsor | Bandırma Onyedi Eylül University (Other) |
| Conditions | Fever, Children |
| Interventions | Vein-imaging device + virtual reality headset group, Vein-imaging device + Buzzy group (Behavioral) |
| Dates | start 2026-02-06, primary completion 2026-12-01 (estimated), completion 2027-01-01 (estimated), first posted 2026-10-20, last updated 2026-10-20 |
| Locations | 1 site in Turkey (Türkiye) |
Related Papers Related Patents Related Grants Related Experts
All trials for Fever All trials for Children All trials of Vein-imaging device + virtual reality headset group All trials of Vein-imaging device + Buzzy group
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Vein-imaging device + virtual reality headset group | Experimental | Behavioral: Vein-imaging device + virtual reality headset group | 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 PIVC insertion. Three minutes before and after the procedure, parents will complete the Descriptive Information Form and 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 | Experimental | Behavioral: Vein-imaging device + Buzzy group | 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 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. |
| Vein-imaging group | No intervention | In the vein visualization group, a vein visualization device will be used during the PIVC procedure in addition to the standard procedure. Three minutes before and three minutes after the procedure, parents will be asked to complete the State-Trait Anxiety Inventory (STAI), and children will be asked to complete the Wong-Baker FACES Pain Rating Scale and the Children's Fear and Anxiety Scales. The researcher will start timing when the nurse applies the tourniquet to the child, and the procedure duration will be recorded on the form once the procedure is completed. In the vein visualization group, the primary endpoint is the success of vascular access and the duration of the intervention. The secondary endpoint is the pain, fear, and anxiety levels experienced by the child in relation to the procedure, which will be assessed three minutes after the vascular access attempt. |
Sex: All, ages: 7 Years to 12 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| Karacabey state hospital | Bursa | Turkey (Türkiye) | Recruiting |