The Effect of Buzzy and Puppet on Pain and Fear

NCT ID: NCT05827783

Last Updated: 2023-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-08

Study Completion Date

2023-03-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pain Fear Nurse's Role

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study was a randomized controlled experimental study.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Implementation of Bee Buzzy

Intervention Type PROCEDURE

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.

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.

Group Type EXPERIMENTAL

Implementation of Puppet Zuzu

Intervention Type PROCEDURE

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ege University

OTHER

Sponsor Role lead

Responsible Party

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Şeyda BİNAY YAZ

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Şeyda Binay Yaz, PhD

Role: PRINCIPAL_INVESTIGATOR

Izmir Bakircay University Hospital

Locations

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Bakırcay University

Izmir, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Yaz SB, Basdemir S, Gectan E. The effect of vibrating cold application and puppet use on pain and fear during phlebotomy in children: A randomized controlled study. J Pediatr Nurs. 2024 Jan-Feb;74:77-84. doi: 10.1016/j.pedn.2023.11.018. Epub 2023 Nov 28.

Reference Type DERIVED
PMID: 38029689 (View on PubMed)

Other Identifiers

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Bakircay University

Identifier Type: -

Identifier Source: org_study_id

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