FeverNCT07882602
Effect of Buzzy and Virtual Reality on Children Undergoing Venous Procedures
A study testing Vein-imaging device + virtual reality headset group and Vein-imaging device + Buzzy group in people with Fever and Children, run by Bandırma Onyedi Eylül University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- What is being tested?
- Vein-imaging device + virtual reality headset group and Vein-imaging device + Buzzy group
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Feb 2026to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Karacabey state hospital
Bursa
Meryem GELMEZ, +90 (0224) 676 10 92, meryemgelmez@ogr.bandirma.edu.tr
About this study
Official title: The Effect of Buzzy and VR on Procedure Duration, Pain, Fear, and Parental Anxiety in Children Undergoing Venous Imaging
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.
Read more
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.
- Being tested
- Vein-imaging device + virtual reality headset group, Vein-imaging device + Buzzy group
- Medical subject headings
- Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vein-imaging device + virtual reality headset groupBehavioural
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 groupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Vein-imaging device + virtual reality headset group | Experimental | 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. Receives: Behavioral: Vein-imaging device + virtual reality headset group |
| Vein-imaging device + Buzzy group | Experimental | 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. Receives: Behavioral: Vein-imaging device + Buzzy group |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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).
Measured: 3 minutes before the procedure and 3 minutes after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start6 Feb 2026
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FeverStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bandırma Onyedi Eylül University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zubeyde Ezgi Ercelik, Bandırma Onyedi Eylül University
- Investigators
- Meryem Gelmez, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07882602
- Sponsor's protocol ID
- E-25691463-050.04-2500036885
- Status last verified
- Oct 2026
- First submitted
- 28 Sep 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
d. Kaynak Listesi (APA stiline uygun yazınız). Akan, Z. (2024). Çocuklarda venöz kan alma sırasında uygulanan aktif dikkat çekme yöntemlerinin ağrı ve korku üzerine etkisi: Düdük çalma ve baloncuk üfleme (Yayınlanmış Yüksek lisans tezi). Atatürk Üniversitesi, Erzurum. Akdemir, M. A. (2019). Çocuklarda venöz kan alma sırasında uygulanan üç farklı yöntemin ağrı ve anksiyete üzerine etkisi: EMLA krem, soğuk sprey ve Buzzy (Yayınlanmış Yüksek lisans tezi). Atatürk Üniversitesi, Erzurum. Can, M., ve Gerçeker, G. Ö. (2024). The effect of the Veinlite PEDI2 and passive virtual reality distraction on peripheral catheter insertion-related emotional behavior, pain, fear, and anxiety of children: A randomized controlled trial. Journal of Pediatric Nursing, 78, e227-e235. Demir, D., & Inal, S. (2019). Does the Use of a Vein Visualization Device for Peripheral Venous Catheter Placement Increase Success Rate in Pediatric Patients?. Pediatric emergency care, 35(7), 474-479. https://doi.org/10.1097/PEC.0000000000001007 Erdogan, B., ve Ozdemir, A. A. (2021). The effect of three different methods on venipuncture pain and anxiety in children: distraction cards, virtual reality, and Buzzy®(randomized controlled trial). Journal of Pediatric Nursing, 58, e54-e62. Eren, H., Topuz, A., & Türkmen, A. S. (2020). Hemşirelik Öğrencilerinin Periferal İntravenöz Kateter Yerleştirme İşlemi Hakkındaki Bilgi ve Beceri Düzeylerinin Belirlenmesi. Hacettepe Üniversitesi Hemşirelik Fakültesi Dergisi, 7(2), 113-121. https://doi.org/10.31125/hunhemsire.763142 Gerçeker, G. Ö., Ayar, D., Özdemir, Z., & Bektaş, M. (2018). Çocuk Anksiyete Skalası-Durumluluk ve Çocuk Korku Ölçeğinin Türk diline kazandırılması. Dokuz Eylül Üniversitesi Hemşirelik Fakültesi Elektronik Dergisi, 11(1), 9-13. http://cocuk-korku-olcegi-toad.pdf/ Gümüş, M. (2017). Periferal venöz kateter uygulamasında ven görüntüleme cihazı kullanımının ilk girişimde başarı oranına etkisi (Yayınlanmış Yüksek lisans tezi). Ege Üniversitesi
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Buzzy and VR on Procedure Duration, Pain, Fear, and Parental Anxiety in Children Undergoing Venous Imaging
- ClinicalTrials.gov ID
- NCT07882602
- Acronym / sponsor ID
- E-25691463-050.04-2500036885
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Bandırma Onyedi Eylül UniversityUniversity, hospital or other
- Study start
- 6 Feb 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 20 Oct 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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vein-imaging device + virtual reality headset group | Experimental | Behavioral: Vein-imaging device + virtual reality headset groupPatients 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 groupPatients 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. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Vein-imaging device + virtual reality headset groupPatients 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. | Behavioural | Vein-imaging device + virtual reality headset group |
| Vein-imaging device + Buzzy groupPatients 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. | Behavioural | Vein-imaging device + Buzzy group |
Primary outcome
Wong-Baker FACES Pain Rating Scale
Time frame: 3 minutes before the procedure and 3 minutes after the procedure
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
Children's Fear and Anxiety Scale (CFAS)
Time frame: 3 minutes before the procedure and 3 minutes after the procedure
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.
STAI State-Trait Anxiety Inventory
Time frame: 3 minutes before the procedure and 3 minutes after the procedure
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Backgroundd. Kaynak Listesi (APA stiline uygun yazınız). Akan, Z. (2024). Çocuklarda venöz kan alma sırasında uygulanan aktif dikkat çekme yöntemlerinin ağrı ve korku üzerine etkisi: Düdük çalma ve baloncuk üfleme (Yayınlanmış Yüksek lisans tezi). Atatürk Üniversitesi, Erzurum. Akdemir, M. A. (2019). Çocuklarda venöz kan alma sırasında uygulanan üç farklı yöntemin ağrı ve anksiyete üzerine etkisi: EMLA krem, soğuk sprey ve Buzzy (Yayınlanmış Yüksek lisans tezi). Atatürk Üniversitesi, Erzurum. Can, M., ve Gerçeker, G. Ö. (2024). The effect of the Veinlite PEDI2 and passive virtual reality distraction on peripheral catheter insertion-related emotional behavior, pain, fear, and anxiety of children: A randomized controlled trial. Journal of Pediatric Nursing, 78, e227-e235. Demir, D., & Inal, S. (2019). Does the Use of a Vein Visualization Device for Peripheral Venous Catheter Placement Increase Success Rate in Pediatric Patients?. Pediatric emergency care, 35(7), 474-479. https://doi.org/10.1097/PEC.0000000000001007 Erdogan, B., ve Ozdemir, A. A. (2021). The effect of three different methods on venipuncture pain and anxiety in children: distraction cards, virtual reality, and Buzzy®(randomized controlled trial). Journal of Pediatric Nursing, 58, e54-e62. Eren, H., Topuz, A., & Türkmen, A. S. (2020). Hemşirelik Öğrencilerinin Periferal İntravenöz Kateter Yerleştirme İşlemi Hakkındaki Bilgi ve Beceri Düzeylerinin Belirlenmesi. Hacettepe Üniversitesi Hemşirelik Fakültesi Dergisi, 7(2), 113-121. https://doi.org/10.31125/hunhemsire.763142 Gerçeker, G. Ö., Ayar, D., Özdemir, Z., & Bektaş, M. (2018). Çocuk Anksiyete Skalası-Durumluluk ve Çocuk Korku Ölçeğinin Türk diline kazandırılması. Dokuz Eylül Üniversitesi Hemşirelik Fakültesi Elektronik Dergisi, 11(1), 9-13. http://cocuk-korku-olcegi-toad.pdf/ Gümüş, M. (2017). Periferal venöz kateter uygulamasında ven görüntüleme cihazı kullanımının ilk girişimde başarı oranına etkisi (Yayınlanmış Yüksek lisans tezi). Ege Üniversitesi
- Individual participant dataSharing planned: No
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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.
Meryem Gelmez study chair
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vein-imaging device + virtual reality headset group and Vein-imaging device + Buzzy group in people with Fever and Children, run by Bandırma Onyedi Eylül 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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 20 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zübeyde Ezgi ERÇELİK, Assistant Professor, PhD (+90 (0266) 717 01 17, zezgiozgenn5@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wong-Baker FACES Pain Rating Scale (time frame: 3 minutes before the procedure and 3 minutes after the procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07882602, which also lists 1 linked publication.
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 Oct 2026.