Clinical trial NCT06849648: Impact of Buzzy and Finger Puppets on Children's Pain, Fear, and Anxiety During Venipuncture
Official title: The Effect of Buzzy and Finger Puppet Show on Children's Pain, Fear, and Anxiety During Venipuncture in the Pediatric Emergency Department: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Management
Nonpharmalogical Pain Management
Children Pain Management
Keywords: Buzzy device
finger puppets
nonpharmacologic methods
pain management in children
Pediatric venipuncture
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
Collaborators: name: Mardin Artuklu University
name: Bartın Unıversity
First posted: 2025-02-27
Enrollment: 102
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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)).
Primary purpose: PREVENTION

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.

Detailed description: This study investigates the effectiveness of the Buzzy device and finger puppets-nonpharmacologic methods-in reducing pain, fear, and anxiety in children aged 4-7 undergoing venipuncture in emergency departments, addressing a gap in current research.

This study was designed as a parallel, randomized and double-blind clinical trial on pediatric patients. Patients who needed to undergo a venipuncture procedure by the emergency nurse were randomly assigned to three different groups: Intervention Group 1 (use of Buzzy device, referred to as Buzzy Group \[BG\]), Intervention Group 2 (distraction with a finger puppet, referred to as Puppet Group \[PG\]), and the Control Group referred to as \[CG\].

Patients in Intervention Group 1 received the Buzzy device during venipuncture, while patients in Intervention Group 2 received distraction with finger puppets. Patients in the Control Group did not receive any intervention. Patients in all groups were subjected to the standard venipuncture procedure.

Children's pain, fear and anxiety levels were assessed by using Wong-Baker Faces Pain Rating Scale, Children's Fear Scale (CFS), Children's Anxiety Meter-State (CAM-S) before and 1 minutes after the venipuncture procedure. These assessments were performed independently by the children themselves.

All venipuncture procedures were carried out by the same nurse who are working in the paediatric emergency ward and had at least eight years of experience with the paediatric venipuncture procedure. Additionally, the nurse received training on how to operate the Buzzy device during venipuncture procedure. Venipuncture was performed with the peripheral venous line.

This method aims to compare the effect of different distraction techniques on children's pain and anxiety levels during venipuncture.

The children were recruited from the paediatric emergency departments of Mardin Training and Research Hospital, in the city of Mardin, in the Southeastern Anatolia Region of Turkey, between January 2025 and June 2025.

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. 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. Also, 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. In addition, 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.

The researcher evaluated participants' baseline information in order to analyse eligibility requirements. Parents of participants in the intervention 1. and 2. groups were informed that Buzzy device and finger puppet play, respectively, would be used for their kids during venipuncture, respectively. Additionally, the participants were informed how to use the Buzzy device and finger puppet play during venipuncture with an age-appropriate language. In the control group, parents were informed that only children's pain, fear and anxiety would be measured before and after the venipuncture procedure. To prevent measurement bias, no additional information was provided to the nurses, the participants and their families.

Eligibility criteria: Inclusion criteria:

* 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.

Exclusion criteria:

* 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.

Primary outcomes:
measure: The Best Pain Management Method
timeFrame: up to 5 months
Secondary outcomes:
measure: Fear Metrics: Understanding and Measuring the Emotion
timeFrame: up to 5 months
Other outcomes:
measure: Anxiety Assessment in Children: Using the CAM-S for Pre- and Post-Procedure Evaluation
timeFrame: up to 5 months
Locations:
city: Mardin
country: Turkey
facility: Mardin Training and Research Hospital
Study officials:
affiliation: Mardin Artuklu University
name: AHMET BUTUN, PhD
role: PRINCIPAL_INVESTIGATOR
References: