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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Control Group | No Intervention | In this group, children received routine vaccination procedure. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buzzy | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Selda Ateş Beşirik, PhD. | Burdur Mehmet Akif Ersoy University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Burdur Bucak | Burdur | Bucak | 15030 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41151224 | Derived | 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. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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This prospective, randomised controlled study.
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| 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. |
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