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Pain ManagementPain ReliefNCT06849648

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

A study testing The Buzzy Device and Finger Puppet in people with Pain Management and Nonpharmalogical Pain Management, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 4 to 7 years
What is being tested?
The Buzzy Device and Finger Puppet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
102 participants
Where
1 siteTurkey (Türkiye)
Study dates
25 Feb 2025to 18 Mar 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 7 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Mardin Training and Research Hospital

    Mardin, Mardin, 47100

Other trials in Turkey (Türkiye)

About this study

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

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).

Read more

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.

Read the 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.

Being tested
The Buzzy Device, Finger Puppet
Keywords
Buzzy device, finger puppets, nonpharmacologic methods, pain management in children, Pediatric venipuncture
Medical subject headings
Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The Buzzy DeviceDevice

    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.

  • Finger PuppetDevice

    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.

Study groups in NCT06849648
Study groupRoleWhat they receive
Experimental AExperimentalthe 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.
Receives: Device: The Buzzy Device
Experimental BExperimentalFinger 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.
Receives: Device: Finger Puppet
Control Group: No intervention is applied; participants receive the standard venipuncture procedure.No interventionChildren 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: up to 5 months

Secondary outcomes (1)
  1. Fear Metrics: Understanding and Measuring the Emotion

    Fear Level: Assessed using the Children's Fear Scale (CFS), which is designed to gauge a child's level of fear before and after the procedure.

    Face 0 'no scared at all'; Face 1 'a little bit more scared'; Face 2 'a bit more scared'; Face 3 'more scared', Face 4 'severe scared' (Figure 3).Therefore, scale scoring ranges from neutral (0=no scared) to frightened (4=severe scared), indicating that as the score increases, the level of fear increases.

    Measured: up to 5 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2025
  2. Study start25 Feb 2025
  3. Primary completion18 Mar 2025
  4. Study completion18 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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)).
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06849648
Sponsor's protocol ID
0000000000000000000002024/11-3
Acronym
Pain Relief
Status last verified
Feb 2025
First submitted
24 Jan 2025
Last updated
15 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Sharing IPD could potentially breach participant confidentiality, especially if sensitive personal data is involved. Ethical guidelines and data protection regulations (e.g., GDPR) require that personal data be kept confidential.

Publications

  • Butun A, Bayraktar S, Catalbas-Acarsoy M, Olgac Ak K. 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. Medicine (Baltimore). 2026 Jun 5;105(23):e49134. doi: 10.1097/MD.0000000000049134.

    PubMed 42260874

Questions about this trial

What is this clinical trial studying?

A study testing The Buzzy Device and Finger Puppet in people with Pain Management and Nonpharmalogical Pain Management, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Best Pain Management Method (time frame: up to 5 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06849648, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2025.

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