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

NCT06849648 | Completed

• 1 other identifier: 0000000000000000000002024/11-3
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Buzzy device; finger puppets; nonpharmacologic methods; pain management in children; Pediatric venipuncture

Outcome Measures

Primary Outcomes (1)

• The Best Pain Management Method

  Pain Level: Measured using the Wong-Baker Faces Pain Rating Scale and Visual This numerical rating scale spans from 0 to 5, with facial expressions representing emotions ranging from a smiling face (0 = very happy/no pain) to a crying face (5 = worst pain)

  up to 5 months

Secondary Outcomes (1)

• Fear Metrics: Understanding and Measuring the Emotion

  up to 5 months

Other Outcomes (1)

• Anxiety Assessment in Children: Using the CAM-S for Pre- and Post-Procedure Evaluation

  up to 5 months

Study Arms (3)

Experimental A

EXPERIMENTAL

the Buzzy device, shaped like a bee or ladybug and featuring a reusable battery, was used for pain management. The device combines cold application with vibration, aided by wing-shaped ice packs. We used the ladybug-shaped Buzzy (Buzzy Healthcare mini ladybuzz, code BKHM3). Following the manufacturer's instructions, the device was held 3-5 cm above the venipuncture site for 30 seconds, then moved just before injection while maintaining vibration throughout the procedure. Ice packs were kept in the freezer but were removed a few minutes before the procedure to avoid discomfort from excessive cold. After the procedure, the device was cleaned with alcohol, and the ice pack was placed back in the freezer for reuse. The total intervention lasted 2-5 minutes, with parents present but not allowed to soothe their children during the procedure.

Device: The Buzzy Device

Experimental B

EXPERIMENTAL

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.

Device: Finger Puppet

Control Group: No intervention is applied; participants receive the standard venipuncture procedure.

NO INTERVENTION

Children in this group were invited for venipuncture procedure in accordance with the standard venipuncture procedure applied in the paediatric emergency department and the procedure was performed. Similarly to intervention groups, any distraction did not used, or families were not allowed to comfort their children during procedure. In this scale, faces are given a pain score according to numerical values.

Interventions

The Buzzy Device 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.

Experimental A

Finger Puppet DEVICE

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.

Experimental B

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• In this study, we included samples of patients aged 4-7 years of both genders who had been admitted to the paediatric emergency ward.
• These children required venepuncture procedures for blood tests.

You may not qualify if:

• The study excluded the children who with chronic disease; who were neuro-developmentally delayed verbal difficulties, hearing or visual impairments;
• Children who had received analgesia or sedation within the previous 24 hours, or had a history of syncope and those were unconscious.
• Children who have bleeding disorder; and infection, rash, damaged skin on the arm where the device will be placed will be excluded from the study.
• Children with cold sensitivity disease such as raynaud's disease and prader-willi syndrome and children who refuse to wear the buzzy device were excluded from the study.

Sponsors & Collaborators

• Kutahya Health Sciences University: lead
• Mardin Artuklu University: collaborator
• Bartın Unıversity: collaborator

Study Sites (1)

Mardin Training and Research Hospital

Mardin, Mardin, 47100, Turkey (Türkiye)

Location

Related Links

• Nonpharmacological pain management uses techniques to reduce pain and anxiety without medications. This guide covers common strategies for children, the role of parents as coaches, age-specific methods, and considerations for chronic pain and development

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• AHMET BUTUN, PhD

  Mardin Artuklu University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participant: The participant doesn't know their group assignment. Investigator: The researcher analyzing the data or designing the study is blinded to the group assignments.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study used a parallel, randomized, double-blind design to evaluate the effects of the Buzzy device and finger puppets on pain, fear, and anxiety in children aged 4-7 undergoing venipuncture. Participants were randomly assigned to the Buzzy Group (Buzzy device applied during venipuncture), Puppet Group (distraction with finger puppets), or Control Group (no intervention). Standardized venipuncture procedures were performed by an experienced pediatric nurse. Pain, fear, and anxiety levels were assessed before and one minute after the procedure using child-friendly scales (Wong-Baker Faces Pain Scale, Children's Fear Scale, and Children's Anxiety Meter-State (CAM-S)).

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: February 27, 2025
• Study Start: February 25, 2025
• Primary Completion: March 18, 2025
• Study Completion: March 18, 2025
• Last Updated: April 15, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)