NCT06566378

Effect of Cold Application and Vibration in Reducing Pain During Vaccination in Children

The Effect of Cold Application and Vibration in Reducing Pain During Vaccination in Children: A Randomized Controlled Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Burdur Mehmet Akif Ersoy University · Academic / Other
• Sex: All
• Age: 13 Years – 13 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
DEVICE	Buzzy	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.
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.

Timeline

• Start date: 2024-04-01
• Primary completion: 2024-12-26
• Completion: 2024-12-26
• First posted: 2024-08-22
• Last updated: 2024-12-27

Locations

1 site across 1 country: Turkey (Türkiye)