The Effect of Buzzy and Puppet on Pain and Fear

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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Fear; Nurse's Role
• Intervention / Treatment: Procedure: Implementation of Bee Buzzy; Procedure: Implementation of Puppet Zuzu

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • İzmir, Turkey, 35665
    • Bakırcay University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bee Buzzy; Bee Buzzy Group: Bee Buzzy was attached to the 3-6-year-old child included in this group by the researcher on the arm of the nurse to perform the phlebotomy procedure. Bee Buzzy reduces pain thanks to its cold wings and vibration. It helps to distract attention during phlebotomy and reduces the feeling of pain and fear. Bee Buzzy was tied 5 cm above the area from which blood will be drawn, and after waiting for 15 seconds, the nurse performed a phlebotomy.	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.
Experimental: Puppet Zuzu; While the nurse was going to perform the phlebotomy operation on the 3-6-year-old child included in this group, one of the researchers (no. 2) tried to distract the child by putting the puppet on her hand and making her talk. The puppet used is an easy-to-use and hand-held puppet that will not cause fear in children. The puppet was named 'Zuzu' by researchers.	Procedure: 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.
No Intervention: Control; No attempt was made to the 3-6-year-old child included in this group, during the process when the nurse performed the phlebotomy. Routine phlebotomy was performed. Pain and fear of the child during the procedure were evaluated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Ege University
• Investigators: Principal Investigator: Şeyda Binay Yaz, PhD, Izmir Bakircay University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2022
• Primary Completion (Actual): March 17, 2023
• Study Completion (Actual): March 30, 2023

Study Registration Dates

• First Submitted: March 30, 2023
• First Submitted That Met QC Criteria: April 12, 2023
• First Posted (Actual): April 25, 2023

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 12, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: pediatrics; Pain; Fear; External cold and vibration; Puppet
• Other Study ID Numbers: Bakircay University

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No