NCT07654192

Brief Summary

Blood sampling can cause pain, anxiety, and fear in children. Such negative experiences may cause the child to develop negative attitudes toward treatment and care procedures. Distraction techniques, which are among non-pharmacological methods, are used to reduce pain, fear, and anxiety by diverting attention away from pain and directing it toward another interesting stimulus. ShotBlocker and finger puppets are one of these techniques. The aim of this study is to evaluate the effectiveness of ShotBlocker and finger puppets in reducing pain and fear in children aged 5-10 years during blood sampling in the pediatric blood sampling unit.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
0mo left

Started Oct 2025

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Oct 2025Jul 2026

Study Start

First participant enrolled

October 1, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2026

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 17, 2026

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2026

Last Updated

June 17, 2026

Status Verified

March 1, 2026

Enrollment Period

9 months

First QC Date

March 11, 2026

Last Update Submit

June 12, 2026

Conditions

Keywords

painfearblood samplingchildren

Outcome Measures

Primary Outcomes (1)

  • Primary Outcome Measure

    The aim of this study is to evaluate the effectiveness of ShotBlocker and finger puppets in reducing pain and fear in children aged 5-10 years during blood sapmling in the pediatric blood collection unit. On the child fear scale, "0" indicates no fear; "4" indicates the highest level of fear. It consists of facial expressions ranging from 0, indicating no pain, to 10, representing severe pain. Data collection takes no more than 10 minutes.

    Time frame is up to 12 moths. From October 01 2025 to October 01 2026.

Secondary Outcomes (7)

  • Randomization

    Time frame is up to 15 minutes.

  • Data Collection Tools

    Time frame is up to 15 minutes.

  • Children's Fear Scale (CFS)

    Time frame is up to 10 minutes.

  • Wong-Baker FACES (WB-FACES) Pain Rating Scale

    Time frame is up to 10 minutes.

  • ShotBlocker

    Time frame is up to 5 minutes.

  • +2 more secondary outcomes

Study Arms (3)

Shotblocker Group

ACTIVE COMPARATOR

Shotblocker is administered to children during the blood sampling collection process.

Other: Distraction techniques

Finger Puppet Group

ACTIVE COMPARATOR

Finger Puppet is administered to children during the blood sampling collection process.

Other: Distraction techniques

Control Group

NO INTERVENTION

No intervention is performed on the control group during the blood sampling collection process.

Interventions

Distraction techniques such as Shotblocker, which are among non-pharmacological methods, are used to reduce pain, fear, and anxiety by diverting attention away from pain and directing it toward another interesting stimulus. Once the children in the Shotblocker group sit down in the blood draw chair, the specified procedure will be applied before the blood drawing begins.

Shotblocker Group

Eligibility Criteria

Age5 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Being between 5 and 10 years old
  • Not having chronic pain
  • Not using sedative/anticonvulsant/analgesic medication
  • Not having a mental or neurological disability
  • Blood collection should be performed by the same nurse

You may not qualify if:

  • Having chronic pain
  • Using sedative/anticonvulsant/analgesic medication
  • Having a mental or neurological disability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abant Izzet Baysal University

Bolu, Turkey (Türkiye)

Location

Related Publications (1)

  • Dinc F, Kurt A, Gunes San E. The effect of three different methods on pain and anxiety in children during blood sampling procedure in pediatric emergency department: Finger puppet, abeslang puzzle, pinwheel. J Pediatr Nurs. 2024 Nov-Dec;79:e203-e212. doi: 10.1016/j.pedn.2024.10.023. Epub 2024 Oct 24.

    PMID: 39448323BACKGROUND

Related Links

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: This study is being conducted using a parallel group randomized controlled trial design.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof

Study Record Dates

First Submitted

March 11, 2026

First Posted

June 17, 2026

Study Start

October 1, 2025

Primary Completion (Estimated)

July 10, 2026

Study Completion (Estimated)

July 10, 2026

Last Updated

June 17, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

The investigators will not share individual participant data for data privacy reasons.

Locations