The Effect of Buzzy and Puppet on Pain and Fear

Not Applicable

Completed

• Conditions: Pain; Fear; Nurse's Role

• Registration Number: NCT05827783
• Lead Sponsor: Ege University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-08
• Primary Completion: 2023-03-17
• Study Completion: 2023-03-30
• Study First Submitted: 2023-03-30
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-12
• Last Update Submitted: 2023-04-12
• Study First Posted: 2023-04-25
• Last Update Posted: 2023-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Statistical difference between groups about pain scores	During the procedure, approximately 5-10 minutes	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.
Statistical difference between groups about fear scores	During the procedure, approximately 5-10 minutes	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.

Trial Locations

Locations (1)

Bakırcay University; 🇹🇷 İzmir, Turkey