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CompletedNCT05827783Updated Apr 25, 2023

The Effect of Buzzy and Puppet on Pain and Fear

An interventional study of Implementation of Bee Buzzy and Implementation of Puppet Zuzu in Pain, Fear and Nurse's Role, sponsored by Ege University. Completed at 1 site in Turkey. Open to participants aged 3 Years to 6 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-25.

Sponsored by Ege University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Jul 2022, registered Mar 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
105
Allocation
Randomized
Ages
3 Years to 6 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Pain
  • Fear
  • Nurse's Role

Keywords

  • Pain
  • Fear
  • External cold and vibration
  • pediatrics
  • Puppet
03

In context

Lead sponsor

Ege University is the lead sponsor of 365 studies on the registry; 46 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 6 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Participants whose child and parents agreed to participate in the study
  • Children who had successful phlebotomy on the first attempt

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
105 participants (actual)

Study arms

  • 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

  • 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

  • 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.

Interventions

  • ProcedureImplementation 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.

  • ProcedureImplementation 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: During the procedure, approximately 5-10 minutes

  2. 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.

    Time frame: During the procedure, approximately 5-10 minutes

07

Study locations

1 site
  • Bakırcay University
    İzmir, 35665, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 25, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05827783
Lead sponsor
Ege University
Responsible party
Şeyda BİNAY YAZ (Assistant professor, Ege University) — Principal investigator
First posted
Apr 25, 2023
Start date
Jul 8, 2022
Primary completion
Mar 17, 2023
Completion
Mar 30, 2023
Last update
Apr 25, 2023

Study contacts

Şeyda Binay Yaz, PhD
principal investigator · Izmir Bakircay University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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