The Effect of Buzzy and Puppet on Pain and Fear

Pain Clinical Trial

Official title:

The Effect of Buzzy and Puppet on Pain and Fear During Phlebotomy in Children: A Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05827783
• Other study ID #: Bakircay University
• Status: Completed
• Phase: N/A
• Start date: July 8, 2022
• Est. completion date: March 30, 2023

Study information

• Verified date: April 2023
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Summary Aim: This study was conducted to evaluate the effects of the use of Bee Buzzy, external vibrating cold application, and the use of puppets on pain and fear in children aged 3 to 6 years during phlebotomy.

Method: This study is a randomized controlled trial. The study was conducted with 105 children aged 3-6 years who came to the pediatric phlebotomy unit of a university hospital. The sample of children (n=105) was divided into groups (group 1, Bee Buzzy; group 2, puppet; group 3, control) by block randomization. Children's pain and fear scores were evaluated using the Wong-Baker Pain Scale and Child Fear Scale, as well as the investigator's report, after phlebotomy, their parents, and the nurse who attempted phlebotomy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: March 30, 2023
• Est. primary completion date: March 17, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 6 Years

Eligibility

Inclusion Criteria:

• Participants whose child and parents agreed to participate in the study

• Children who had successful phlebotomy on the first attempt

Exclusion Criteria:

• Children with chronic disease, mental disability, or mental retardation

• Children who had taken analgesics in the last 24 hours

• Children who were hospitalized

• Children who had undergone a surgical procedure

• Children who did not have successful phlebotomy on the first attempt

Related Conditions & MeSH terms

• Fear
• Nurse's Role
• Pain

Intervention

Procedure:
• Implementation of Bee Buzzy
Implementation of Bee Buzzy It is defined as the use of a device called Bee Buzzy, which applies cold and vibrates in the form of a toy bee, by the researcher for fear and pain during phlebotomy in children. Nurse performs phlebotomy on pediatric patients in the pediatric phlebotomy unit. During this application, the researcher puts the Bee Buzzy device on the child's arm just above the area from which blood was taken, and remains attached to the arm during the phlebotomy procedure. This device applies cold and vibrates. Pain and fear during the procedure are evaluated by the researcher, the nurse, and the child's parent.
• Implementation of Puppet Zuzu
Implementation of puppet zuzu It is defined as the use of a puppet that is seized and made to talk by the researcher for fear and pain during phlebotomy in children. Nurse performs phlebotomy on pediatric patients in the pediatric phlebotomy unit. During this practice, a puppet is seized by the researcher and made to talk, and the child's attention is tried to be drawn. While this procedure is in progress, the researcher, the nurse, and the child's parent evaluate the pain and fear during the procedure.

Locations

Country	Name	City	State
Turkey	Bakircay University	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Statistical difference between groups about pain scores	Implementation of interventions aimed at reducing pain in experimental groups. Wong-Baker Facial Pain Rating Scale: The Facial Expression Rating Scale is a scale that includes 6 facial expressions and provides a rating between 0-10. This scale, which does not require words, is a reliable and valid measurement tool in the assessment of acute pain. A score of 0 indicates no pain and a score of 10 indicates the highest level of pain. In the scale, it means that as the pain score increases, the pain also increases.	During the procedure, approximately 5-10 minutes
Primary	Statistical difference between groups about fear scores	Implementation of interventions aimed at reducing fear in experimental groups. Children's Fear Scale: This scale includes 5 different facial expressions. This scale is scored between 0-4 and it is stated to be a reliable and valid measurement tool in the evaluation of fear. This scale does not require words. A score of 0 indicates no fear and a score of 4 indicates the highest level of fear. In the scale, it means that as the fear score increases, the fear also increases.	During the procedure, approximately 5-10 minutes