PainNCT06566378
Effect of Cold Application and Vibration in Reducing Pain During Vaccination in Children
A study testing Buzzy and Buzzy (Placed in standard) in people with Pain and Pain, Acute, run by Burdur Mehmet Akif Ersoy University at 1 site in Turkey (Türkiye).
Trial summary
The study was designed as a randomized controlled experimental research with the purpose of determining the effect of using Cold Application and Vibration in reducing pain during routine vaccination in children. Read more about this study
- Who is it for?
- Ages 13 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Pain, Acute, Vaccination
- What is being tested?
- Buzzy and Buzzy (Placed in standard)
- Type of treatment
- Vaccines, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2024to 26 Dec 2024
- 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 13 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children the ages of 13 years (planned to be included in the vaccination calendar program),
- Volunteering of the child and parent to participate in the study,
- Healthy children,
- Vaccination should be done by the same nurse,
Who cannot join
- The child has any acute or chronic disease,
- The child has a mental disability, vision, speech or communication problems,
- The parent has hearing, vision or verbal communication difficulties,
- The child used analgesics in the last 6 hours,
- Infection, disruption of skin integrity and rash in the area where theapplication will be made,
- Exclusion criteria were that the parent or child wanted to leave the study at any point.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Cold Application and Vibration in Reducing Pain During Vaccination in Children: A Randomized Controlled Study
The study was designed as a randomized controlled experimental research with the purpose of determining the effect of using Cold Application and Vibration in reducing pain during routine vaccination in children.
Read the detailed description
In the literature, it is stated that nurses should use pharmacological and non-pharmacological methods in pain and anxiety management in painful procedures. Evidence-based studies are needed to show the effectiveness of non-pharmacological methods in reducing pain during invasive procedures and to investigate the effects of easy-to-apply methods on pain.In light of this information, this study aimed to examine the effect of by using Cold Application and Vibration in reducing pain during routine vaccination in children. Cold Application and Vibration will be done with BUZZY.
This study is a prospective, randomized and controlled trial. Children aged 13 years who required routine vaccination were divided into three groups; placed under arm Buzzy, placed in standard Buzzy, and Control. Data were obtained through face-to-face interviews with the children, their parents, and the observer before and after the procedure. The children's pain levels were assessed and reported by the parents and observers and the children themselves who selfreported using Wong-Baker FACES.
The study population consisted of the children's during routine vaccination in children aged 13 years. Sample of the study consisted of a total of 90 children who met the sample selection criteria and were selected via randomization method.
Children were randomized into three groups; placed under arm Buzzy (n:30), placed in standard Buzzy (n:30), and Control (n:30). Data were collected using the Interview and Observation Form and Wong-Baker FACES Pain Rating Scale.
- Conditions
- Pain, Pain, Acute, Vaccination, Children, Cold Application, Vibration
- Being tested
- Buzzy, Buzzy (Placed in standard)
- Keywords
- pain, Vaccination, Child, Cold Application, Vibration, Buzzy
- Medical subject headings
- Pain, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BuzzyDevice
In children pre-procedure, buzzy was placed under the armpit. The children were made before starting the application. It continued until the end of vaccination procedure.
Buzzy (Placed in standard)Device
In children pre-procedure, buzzy was placed on the arm. The children were made before starting the application. It continued until the end of vaccination procedure.
| Study group | Role | What they receive |
|---|---|---|
| Placed under arm Buzzy Group | Experimental | In children pre-procedure, buzzy was placed under the armpit. The children were made before starting the application. It continued until the end of vaccination procedure. Receives: Device: Buzzy |
| Placed in standard Buzzy Group | Experimental | In children pre-procedure, buzzy was placed on the arm. The children were made before starting the application. It continued until the end of vaccination procedure. Receives: Device: Buzzy (Placed in standard) |
| Control Group | No intervention | In this group, children received routine vaccination procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wong-Baker FACES Pain Rating Scale
In the study, pain level evaluations, the children's self-evaluations, parents' evaluations and the researcher's evaluations were carried out using the WB-FACES scale. This scale was developed by Donna Wong and Connie Morain Baker in 1988. The scale is graded between 0-10 points. A smiling face on the far left symbolizes "no pain" (0 very happy/no pain) and the pain increases from left to right. On the other hand, a crying face on the far right symbolizes "unbearable pain" (10 'hurts worst'). As the numbers increase in this scoring system, facial expressions also change referring to an increase in pain levels.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start1 Apr 2024
- Primary completion26 Dec 2024
- Study completion26 Dec 2024
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 PainStudies 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
- Model description
- This prospective, randomised controlled study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Burdur Mehmet Akif Ersoy University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selda Ateş Beşirik, Burdur Mehmet Akif Ersoy University
- Investigators
- Selda Ateş Beşirik, PhD., Principal investigator, Burdur Mehmet Akif Ersoy University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06566378
- Sponsor's protocol ID
- GO 2024/175
- Status last verified
- Dec 2024
- First submitted
- 20 Aug 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ates Besirik S, Turgut MA, Sahiner NC, Baxter AL, Kirboga Z. Reducing vaccination pain using a multidermatomal or deltoid region buzzy(R) applications versus control: A randomized controlled study. J Pediatr Nurs. 2025 Nov-Dec;85:783-791. doi: 10.1016/j.pedn.2025.10.011. Epub 2025 Oct 27.
PubMed 41151224
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cold Application and Vibration in Reducing Pain During Vaccination in Children: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06566378
- Acronym / sponsor ID
- GO 2024/175
- Conditions
- Pain, Pain, Acute, Vaccination, Children, Cold Application, Vibration
- Keywords
- pain, Vaccination, Child, Cold Application, Vibration, Buzzy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Burdur Mehmet Akif Ersoy UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 26 Dec 2024 (actual)
- Study completion
- 26 Dec 2024 (actual)
- First posted
- 22 Aug 2024 (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.
The study was designed as a randomized controlled experimental research with the purpose of determining the effect of using Cold Application and Vibration in reducing pain during routine vaccination in children.
Detailed description
In the literature, it is stated that nurses should use pharmacological and non-pharmacological methods in pain and anxiety management in painful procedures. Evidence-based studies are needed to show the effectiveness of non-pharmacological methods in reducing pain during invasive procedures and to investigate the effects of easy-to-apply methods on pain.In light of this information, this study aimed to examine the effect of by using Cold Application and Vibration in reducing pain during routine vaccination in children. Cold Application and Vibration will be done with BUZZY.
This study is a prospective, randomized and controlled trial. Children aged 13 years who required routine vaccination were divided into three groups; placed under arm Buzzy, placed in standard Buzzy, and Control. Data were obtained through face-to-face interviews with the children, their parents, and the observer before and after the procedure. The children's pain levels were assessed and reported by the parents and observers and the children themselves who selfreported using Wong-Baker FACES.
The study population consisted of the children's during routine vaccination in children aged 13 years. Sample of the study consisted of a total of 90 children who met the sample selection criteria and were selected via randomization method.
Children were randomized into three groups; placed under arm Buzzy (n:30), placed in standard Buzzy (n:30), and Control (n:30). Data were collected using the Interview and Observation Form and Wong-Baker FACES Pain Rating Scale.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- This prospective, randomised controlled study.
| Arm | Type | Receives |
|---|---|---|
| Placed under arm Buzzy Group | Experimental | Device: BuzzyIn children pre-procedure, buzzy was placed under the armpit. The children were made before starting the application. It continued until the end of vaccination procedure. |
| Placed in standard Buzzy Group | Experimental | Device: Buzzy (Placed in standard)In children pre-procedure, buzzy was placed on the arm. The children were made before starting the application. It continued until the end of vaccination procedure. |
| Control Group | No intervention | –In this group, children received routine vaccination procedure. |
Who may qualify
- Ages
- 13 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children the ages of 13 years (planned to be included in the vaccination calendar program),
- Volunteering of the child and parent to participate in the study,
- Healthy children,
- Vaccination should be done by the same nurse,
Key exclusion criteria (6 listed)
- The child has any acute or chronic disease,
- The child has a mental disability, vision, speech or communication problems,
- The parent has hearing, vision or verbal communication difficulties,
- The child used analgesics in the last 6 hours,
- Infection, disruption of skin integrity and rash in the area where theapplication will be made,
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 |
|---|---|---|
| BuzzyIn children pre-procedure, buzzy was placed under the armpit. The children were made before starting the application. It continued until the end of vaccination procedure. | Device | Placed under arm Buzzy Group |
| Buzzy (Placed in standard)In children pre-procedure, buzzy was placed on the arm. The children were made before starting the application. It continued until the end of vaccination procedure. | Device | Placed in standard Buzzy Group |
Primary outcome
Wong-Baker FACES Pain Rating Scale
Time frame: Through study completion, an average of 1 year
In the study, pain level evaluations, the children's self-evaluations, parents' evaluations and the researcher's evaluations were carried out using the WB-FACES scale. This scale was developed by Donna Wong and Connie Morain Baker in 1988. The scale is graded between 0-10 points. A smiling face on the far left symbolizes "no pain" (0 very happy/no pain) and the pain increases from left to right. On the other hand, a crying face on the far right symbolizes "unbearable pain" (10 'hurts worst'). As the numbers increase in this scoring system, facial expressions also change referring to an increase in pain levels.
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 27 Dec 2024.
- Derived from this study: PubMed 41151224Ates Besirik S, Turgut MA, Sahiner NC, Baxter AL, Kirboga Z. Reducing vaccination pain using a multidermatomal or deltoid region buzzy(R) applications versus control: A randomized controlled study. J Pediatr Nurs. 2025 Nov-Dec;85:783-791. doi: 10.1016/j.pedn.2025.10.011. Epub 2025 Oct 27.
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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.
Selda Ateş Beşirik, PhD. principal investigator
Burdur Mehmet Akif Ersoy University
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 Buzzy (Placed in standard) in people with Pain and Pain, Acute, run by Burdur Mehmet Akif Ersoy 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 4 inclusion and 6 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 27 Dec 2024. 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?
Wong-Baker FACES Pain Rating Scale (time frame: Through study completion, an average of 1 year). 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 NCT06566378, 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 27 Dec 2024.