An interventional study of Vein-imaging device + virtual reality headset group and Vein-imaging device + Buzzy group in Fever and Children, sponsored by Bandırma Onyedi Eylül University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 7 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Bandırma Onyedi Eylül University · Not applicable, Interventional, and Supportive care
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.
605 studies on the registry are indexed under Fever; 98 are open to participants now.
This study's planned enrollment of 105 is close to the median of 100 across 386 interventional studies indexed under Fever.
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Exclusion Criteria:
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.
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. 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.
Behavioral: Vein-imaging device + Buzzy group
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.
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.
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.
Wong-Baker FACES Pain Rating Scale
The Wong-Baker FACES Pain Rating Scale, used to assess pain in this study, was first developed by Donna Wong and Connie Morain Baker in 1981 and revised in 1983. It is a visually based instrument, widely used worldwide, for assessing pain intensity in children aged three years and older, and it allows children to express themselves through facial expressions. The scale consists of six different facial expressions: the smiling face on the far left represents no pain (a score of 0), whereas the crying face on the far right represents severe pain (a score of 10). When administering the scale, the meaning of each face is explained to the child, and the child is asked to select the face that best represents how they feel. The scale has frequently been used in similar studies conducted in Türkiye (Erdoğan \& Aytekin Özdemir, 2021; Gerçeker et al., 2018). An email requesting permission was sent to the official website of the Wong-Baker FACES Foundation, and the Turkish version of the scale an
Time frame: 3 minutes before the procedure and 3 minutes after the procedure
Children's Fear and Anxiety Scale (CFAS)
Developed by McMurtry and colleagues in 2011, this scale was designed to assess children's levels of fear and anxiety. Its validity and reliability in Turkish were established by Gerçeker et al. (2018). The scale is administered by presenting children with a visual display containing five different facial expressions that can be rated on a scale from 0 to 4. Each facial expression represents a specific emotional state. The assessment can be conducted by researchers or parents to determine levels of fear and anxiety both before and during a procedure. On the scale, a score of "0" indicates that the child experiences no fear or anxiety, while a score of "4" represents the highest level of fear and anxiety (Gerçeker et al., 2018; Akdemir, 2019; Akan, 2024). Since the Child Fear and Anxiety Scale is a sum-scored instrument, item-total correlations and the Cronbach's alpha coefficient could not be calculated.
Time frame: 3 minutes before the procedure and 3 minutes after the procedure
STAI State-Trait Anxiety Inventory
The State-Trait Anxiety Inventory (STAI), developed by Spielberger et al. (1970) to assess anxiety as both a temporary state and an enduring trait, was adapted into Turkish, with validity and reliability established, by Öner and Le Compte (1998). It comprises two 20-item subscales, state and trait. Items are rated on a four-point Likert scale; total scores range from 20 to 80, with higher scores indicating greater anxiety (Fırat, 2016; Kaçmaz, 2024). Scores below 36 indicate no anxiety, 37-42 mild anxiety, and 42 or above high anxiety (Yurdaor et al., 2022). For the Turkish version, Kuder-Richardson alpha coefficients ranged from 0.83 to 0.87 (trait) and 0.94 to 0.96 (state); item-remainder correlations from 0.34 to 0.72 (trait) and 0.42 to 0.85 (state); test-retest coefficients from 0.71 to 0.86 (trait) and 0.26 to 0.68 (state). The state subscale, a validated measure, will be used to assess parental anxiety (Fırat, 2016; Kaçmaz, 2024; Yurdaor et al., 2022).
Time frame: 3 minutes before the procedure and 3 minutes after the procedure
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