Impact of Buzzy and Finger Puppets on Children's Pain, Fear, and Anxiety During Venipuncture

NCT06849648 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2025-04-15

No results posted yet for this study

Summary

This study evaluates the impact of the Buzzy device and finger puppet distraction on pain, fear, and anxiety in children aged 4-7 undergoing venipuncture in a pediatric emergency department. Designed as a parallel, randomized, double-blind clinical trial, participants were divided into three groups: Buzzy Group (BG), Puppet Group (PG), and a Control Group (CG).

The Buzzy Group used the Buzzy device during venipuncture, the Puppet Group received finger puppet distraction, and the Control Group underwent standard venipuncture with no intervention. Pain, fear, and anxiety levels were assessed before and one minute after venipuncture using child-friendly scales, including the Wong-Baker Faces Pain Scale, Children's Fear Scale (CFS), and Children's Anxiety Meter-State (CAM-S).

All procedures were performed by an experienced pediatric nurse trained in Buzzy device usage. Recruitment took place at Mardin Training and Research Hospital from January to June 2025, focusing on children aged 4-7 without chronic illnesses, neurodevelopmental delays, or other exclusion criteria such as prior sedation or cold sensitivity disorders. Parents and children in the intervention groups were educated about the respective techniques in age-appropriate language.

This trial aims to compare the effectiveness of these nonpharmacologic interventions in reducing procedural distress, providing evidence-based solutions for managing pain and anxiety in pediatric emergency settings.

Conditions

  • Pain Management
  • Nonpharmalogical Pain Management
  • Children Pain Management

Interventions

DEVICE

The Buzzy Device

In essence, the Buzzy device offers a multi-sensory approach (vibration + cold) in conjunction with a hygienic protocol, which is a key differentiator from other non-pharmacological interventions such as distraction through toys, videos, or verbal techniques. Currently, there is no studies evaluating the use of the Buzzy device and finger puppets, which are nonpharmacologic methods, in relation to the levels of pain, fear, and anxiety in children aged 4-7 years undergoing venipuncture procedures in emergency department settings.

DEVICE

Finger Puppet

Finger puppets were used to distract the participants during venepuncture procedure. Children are allowed to pick their favourite animals. These soft in various shaped finger puppets can be placed on adult's fingers. One minute before the venipuncture procedure, the researcher (K.O.) engaged the participants in finger puppet play and initiated conversation by asking; 'Hello, how are you? What is this figure? Do you know where this animal/figure live in? Have you previously seen this animal/figure alive? Have you been in a zoo? Additionally, techniques such as having the animals 'sing' or 'interact' with each other were employed to capture the child's attention on the finger puppets. Children in this group were not given any distraction techniques prior to the procedure. All groups' parents accompanied over their children during the process, but they were not permitted to comfort them.

Sponsors & Collaborators

  • Mardin Artuklu University

    collaborator OTHER
  • Bartın Unıversity

    collaborator OTHER
  • Kutahya Health Sciences University

    lead OTHER

Principal Investigators

  • AHMET BUTUN, PhD · Mardin Artuklu University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-25
Primary Completion
2025-03-18
Completion
2025-03-18

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06849648 on ClinicalTrials.gov