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Completed

NCT Number: NCT06566378

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

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.

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Key information

Conditions

Pain Acute Pain Children Cold Application Neurologic Manifestations Pain, Acute Pathological Conditions, Signs and Symptoms Signs and Symptoms Vaccination Vibration

Age range

13 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Burdur Bucak

Burdur, Bucak, 15030, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Burdur Mehmet Akif Ersoy University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 22, 2024
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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