PainNCT07851909
The Effect of Buzzy® and a Stress Ball on Reducing Pain and Fear During Peripheral Intravenous Cannulation in Children
A study testing Buzzy and Stress Ball in people with Pain and Fear, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to compare the effects of Buzzy®, a device that applies cold and vibration, and a stress ball on pain and fear during intravenous catheter insertion in children aged 7-12 years. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Fear, Pain Management
- What is being tested?
- Buzzy and Stress Ball
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2025to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 7-12 years
- No chronic illness or intellectual or neurological disability
- No acute pain at hospital admission
- No neurodevelopmental disorder or life-threatening condition, such as sepsis, shock, or respiratory or cardiac arrest
- No analgesic medication within 6 hours before the procedure
- Both the child and parent able to speak and understand Turkish
- No intravenous catheter insertion within the previous year
Who cannot join
- Hearing, visual, or cognitive impairment
- Not accompanied by a primary caregiver (mother or father)
- Unconscious upon hospital admission
- More than one attempt required for intravenous catheter insertion in the emergency department
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Buzzy® and a Stress Ball on Reducing Pain and Fear During Peripheral Intravenous Cannulation in Children: A Randomized Controlled Trial
This study aims to compare the effects of Buzzy®, a device that applies cold and vibration, and a stress ball on pain and fear during intravenous catheter insertion in children aged 7-12 years. It seeks to answer whether one method is more effective than the other in reducing children's pain and fear during the procedure.
- Conditions
- Pain, Fear, Pain Management
- Being tested
- Buzzy, Stress Ball
- Medical subject headings
- Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BuzzyBehavioural
Before intravenous catheter insertion, the Buzzy® device was placed approximately 5 cm above the insertion site on the child's arm. After 15 seconds of cold and vibration, a research nurse inserted the catheter. The device remained in place until 5 minutes after the procedure and was disinfected before and after each use.
Stress BallBehavioural
Before intravenous catheter insertion, children were given a stress ball to hold in the hand opposite the insertion site. A few seconds after they began squeezing the ball, the procedure started. Children were asked to continue squeezing and releasing the ball until catheter insertion was complete. The stress ball was disinfected before and after each use.
| Study group | Role | What they receive |
|---|---|---|
| Intervention:Buzzy | Experimental | Not described Receives: Behavioral: Buzzy |
| Intervention:Stress Ball | Experimental | Not described Receives: Behavioral: Stress Ball |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fear-Children's Fear Scale (CFS)
Children's Fear Scale (CFS): Developed by McMurtry and colleagues in 2011 and adapted into Turkish by Özalp Gerçeker and colleagues in 2018, the scale measures children's fear and anxiety. It has five facial expressions scored from 0 (no fear) to 4 (severe fear). In this study, the scale was completed 5 minutes before and 5 minutes after intravenous catheter insertion.
Measured: The Children's Fear Scale was completed 5 minutes before and 5 minutes after intravenous catheter insertion.
Pain-Wong-Baker FACES Pain Rating Scale
Wong-Baker FACES Pain Rating Scale: Developed by Donna Wong and Connie Baker in 1981 and revised in 2012, this scale uses six faces to help children rate their pain. Scores range from 0 (no pain) to 10 (worst pain), with higher scores indicating greater pain. In this study, children will use the scale to rate their pain during intravenous catheter insertion.
Measured: The Wong-Baker FACES Pain Rating Scale was completed 5 minutes before and 5 minutes after intravenous catheter insertion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start1 Sep 2025
- Primary completion1 Mar 2026
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma DURSUN ERGEZEN, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07851909
- Sponsor's protocol ID
- F_Ergezen_YL
- Status last verified
- Sep 2026
- First submitted
- 25 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guillari A, Giordano V, Catone M, Gallucci M, Rea T. Non-pharmacological interventions to reduce procedural needle pain in children (6-12 years): A systematic review. J Pediatr Nurs. 2024 Sep-Oct;78:e102-e116. doi: 10.1016/j.pedn.2024.06.025. Epub 2024 Jul 16.
PubMed 39013701Sonmez Duzkaya D, Uysal G, Siktas O, Karakul A, Acikgoz A. Effects of the Helfer skin tap technique and Buzzy(R) application on the levels of pain and fear experienced by children during vaccination: A randomized controlled trial. J Pediatr Nurs. 2024 Nov-Dec;79:e278-e284. doi: 10.1016/j.pedn.2024.10.037. Epub 2024 Nov 2.
PubMed 39489632Duzkaya DS, Bozkurt G, Ulupinar S, Uysal G, Ucar S, Uysalol M. The Effect of a Cartoon and an Information Video About Intravenous Insertion on Pain and Fear in Children Aged 6 to 12 Years in the Pediatric Emergency Unit: A Randomized Controlled Trial. J Emerg Nurs. 2021 Jan;47(1):76-87. doi: 10.1016/j.jen.2020.04.011. Epub 2020 Jul 18.
PubMed 32690314Cho YH, Chiang YC, Chu TL, Chang CW, Chang CC, Tsai HM. The Effectiveness of the Buzzy Device for Pain Relief in Children During Intravenous Injection: Quasirandomized Study. JMIR Pediatr Parent. 2022 Apr 29;5(2):e15757. doi: 10.2196/15757.
PubMed 35486419Ballard A, Khadra C, Adler S, Trottier ED, Le May S. Efficacy of the Buzzy Device for Pain Management During Needle-related Procedures: A Systematic Review and Meta-Analysis. Clin J Pain. 2019 Jun;35(6):532-543. doi: 10.1097/AJP.0000000000000690.
PubMed 30829735Aydin D, Sahiner NC, Ciftci EK. Comparison of the effectiveness of three different methods in decreasing pain during venipuncture in children: ball squeezing, balloon inflating and distraction cards. J Clin Nurs. 2016 Aug;25(15-16):2328-35. doi: 10.1111/jocn.13321. Epub 2016 Apr 26.
PubMed 27112434Ali S, Manaloor R, Ma K, Sivakumar M, Beran T, Scott SD, Vandermeer B, Beirnes N, Graham TAD, Curtis S, Jou H, Hartling L. A randomized trial of robot-based distraction to reduce children's distress and pain during intravenous insertion in the emergency department. CJEM. 2021 Jan;23(1):85-93. doi: 10.1007/s43678-020-00023-5. Epub 2020 Dec 10.
PubMed 33683608
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Buzzy® and a Stress Ball on Reducing Pain and Fear During Peripheral Intravenous Cannulation in Children: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07851909
- Acronym / sponsor ID
- F_Ergezen_YL
- Conditions
- Pain, Fear, Pain Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 1 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.
This study aims to compare the effects of Buzzy®, a device that applies cold and vibration, and a stress ball on pain and fear during intravenous catheter insertion in children aged 7-12 years. It seeks to answer whether one method is more effective than the other in reducing children's pain and fear during the procedure.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention:Buzzy | Experimental | Behavioral: Buzzy |
| Intervention:Stress Ball | Experimental | Behavioral: Stress Ball |
| Control | No intervention | – |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Children aged 7-12 years
- No chronic illness or intellectual or neurological disability
- No acute pain at hospital admission
- No neurodevelopmental disorder or life-threatening condition, such as sepsis, shock, or respiratory or cardiac arrest
- No analgesic medication within 6 hours before the procedure
Key exclusion criteria (4 listed)
- Hearing, visual, or cognitive impairment
- Not accompanied by a primary caregiver (mother or father)
- Unconscious upon hospital admission
- More than one attempt required for intravenous catheter insertion in the emergency department
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 |
|---|---|---|
| BuzzyBefore intravenous catheter insertion, the Buzzy® device was placed approximately 5 cm above the insertion site on the child's arm. After 15 seconds of cold and vibration, a research nurse inserted the catheter. The device remained in place until 5 minutes after the procedure and was disinfected before and after each use. | Behavioural | Intervention:Buzzy |
| Stress BallBefore intravenous catheter insertion, children were given a stress ball to hold in the hand opposite the insertion site. A few seconds after they began squeezing the ball, the procedure started. Children were asked to continue squeezing and releasing the ball until catheter insertion was complete. The stress ball was disinfected before and after each use. | Behavioural | Intervention:Stress Ball |
Primary outcome
Fear-Children's Fear Scale (CFS)
Time frame: The Children's Fear Scale was completed 5 minutes before and 5 minutes after intravenous catheter insertion.
Children's Fear Scale (CFS): Developed by McMurtry and colleagues in 2011 and adapted into Turkish by Özalp Gerçeker and colleagues in 2018, the scale measures children's fear and anxiety. It has five facial expressions scored from 0 (no fear) to 4 (severe fear). In this study, the scale was completed 5 minutes before and 5 minutes after intravenous catheter insertion.
Pain-Wong-Baker FACES Pain Rating Scale
Time frame: The Wong-Baker FACES Pain Rating Scale was completed 5 minutes before and 5 minutes after intravenous catheter insertion.
Wong-Baker FACES Pain Rating Scale: Developed by Donna Wong and Connie Baker in 1981 and revised in 2012, this scale uses six faces to help children rate their pain. Scores range from 0 (no pain) to 10 (worst pain), with higher scores indicating greater pain. In this study, children will use the scale to rate their pain during intravenous catheter insertion.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Results publication: PubMed 39013701Guillari A, Giordano V, Catone M, Gallucci M, Rea T. Non-pharmacological interventions to reduce procedural needle pain in children (6-12 years): A systematic review. J Pediatr Nurs. 2024 Sep-Oct;78:e102-e116. doi: 10.1016/j.pedn.2024.06.025. Epub 2024 Jul 16.
- Results publication: PubMed 39489632Sonmez Duzkaya D, Uysal G, Siktas O, Karakul A, Acikgoz A. Effects of the Helfer skin tap technique and Buzzy(R) application on the levels of pain and fear experienced by children during vaccination: A randomized controlled trial. J Pediatr Nurs. 2024 Nov-Dec;79:e278-e284. doi: 10.1016/j.pedn.2024.10.037. Epub 2024 Nov 2.
- Results publication: PubMed 32690314Duzkaya DS, Bozkurt G, Ulupinar S, Uysal G, Ucar S, Uysalol M. The Effect of a Cartoon and an Information Video About Intravenous Insertion on Pain and Fear in Children Aged 6 to 12 Years in the Pediatric Emergency Unit: A Randomized Controlled Trial. J Emerg Nurs. 2021 Jan;47(1):76-87. doi: 10.1016/j.jen.2020.04.011. Epub 2020 Jul 18.
- Results publication: PubMed 35486419Cho YH, Chiang YC, Chu TL, Chang CW, Chang CC, Tsai HM. The Effectiveness of the Buzzy Device for Pain Relief in Children During Intravenous Injection: Quasirandomized Study. JMIR Pediatr Parent. 2022 Apr 29;5(2):e15757. doi: 10.2196/15757.
- Results publication: PubMed 30829735Ballard A, Khadra C, Adler S, Trottier ED, Le May S. Efficacy of the Buzzy Device for Pain Management During Needle-related Procedures: A Systematic Review and Meta-Analysis. Clin J Pain. 2019 Jun;35(6):532-543. doi: 10.1097/AJP.0000000000000690.
- Results publication: PubMed 27112434Aydin D, Sahiner NC, Ciftci EK. Comparison of the effectiveness of three different methods in decreasing pain during venipuncture in children: ball squeezing, balloon inflating and distraction cards. J Clin Nurs. 2016 Aug;25(15-16):2328-35. doi: 10.1111/jocn.13321. Epub 2016 Apr 26.
- Results publication: PubMed 33683608Ali S, Manaloor R, Ma K, Sivakumar M, Beran T, Scott SD, Vandermeer B, Beirnes N, Graham TAD, Curtis S, Jou H, Hartling L. A randomized trial of robot-based distraction to reduce children's distress and pain during intravenous insertion in the emergency department. CJEM. 2021 Jan;23(1):85-93. doi: 10.1007/s43678-020-00023-5. Epub 2020 Dec 10.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Buzzy and Stress Ball in people with Pain and Fear, run by Akdeniz 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 7 inclusion and 4 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: finished, as of the sponsor's last update on 1 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fear-Children's Fear Scale (CFS) (time frame: The Children's Fear Scale was completed 5 minutes before and 5 minutes after intravenous catheter insertion.). The study lists 2 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 NCT07851909, which also lists 7 linked publications.
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 1 Oct 2026.