Clinical trial NCT06566378: Effect of Cold Application and Vibration in Reducing Pain During Vaccination in Children
Official title: The Effect of Cold Application and Vibration in Reducing Pain During Vaccination in Children: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Pain, Acute
Vaccination
Children
Cold Application
Vibration
Keywords: pain
Vaccination
Child
Cold Application
Vibration
Buzzy
Lead sponsor: Burdur Mehmet Akif Ersoy University
Sponsor class: OTHER
First posted: 2024-08-22
Enrollment: 90
Sex: ALL
Minimum age (years): 13
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This prospective, randomised controlled study.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* 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,

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Wong-Baker FACES Pain Rating Scale
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Burdur
country: Turkey
facility: Burdur Bucak
state: Bucak
Study officials:
affiliation: Burdur Mehmet Akif Ersoy University
name: Selda Ateş Beşirik, PhD.
role: PRINCIPAL_INVESTIGATOR
References: