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

NCT06566378 | Completed

• 1 other identifier: GO 2024/175
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Pain, Acute; Vaccination; Children; Cold Application; Vibration

Keywords

pain; Vaccination; Child; Cold Application; Vibration; Buzzy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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.

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.

Device: Buzzy (Placed in standard)

Control Group

NO INTERVENTION

In this group, children received routine vaccination procedure.

Interventions

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.

Placed under arm Buzzy Group

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.

Placed in standard Buzzy Group

Eligibility Criteria

• Age: 13 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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,

You may not qualify if:

• 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,

Sponsors & Collaborators

• Burdur Mehmet Akif Ersoy University: lead

Study Sites (1)

Burdur Bucak

Burdur, Bucak, 15030, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 41151224 DERIVED

MeSH Terms

Conditions

Pain; Acute Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Selda Ateş Beşirik, PhD.

  Burdur Mehmet Akif Ersoy University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This prospective, randomised controlled study.

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: August 22, 2024
• Study Start: April 1, 2024
• Primary Completion: December 26, 2024
• Study Completion: December 26, 2024
• Last Updated: December 27, 2024

Record last verified: 2024-12

Locations

TU (1)