NCT05904483

Brief Summary

Blood sampling is an invasive, diagnostic, and therapeutic procedure for children. The inability of preschool children to differentiate between reality and imagination and their belief in the power of their thoughts make it difficult for them to accept an invasive procedure. Distraction techniques are used to help children cope with pain and anxiety. The aim of this study is to compare the effects of finger puppet, abeslang puzzle, and pinwheel on pain and anxiety during blood sampling in preschool children presenting to the pediatric emergency department. This randomized controlled study used parallel trial design.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 15, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

June 20, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2024

Completed
Last Updated

June 25, 2024

Status Verified

June 1, 2024

Enrollment Period

1 year

First QC Date

June 6, 2023

Last Update Submit

June 21, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • The level of pain during blood sampling is evaluated using the Wong-Baker FACES Pain Rating Scale

    This scale is used to assess the severity of pain in children aged 3 years and above. This numerical rating scale ranges from 0 to 10, indicating emotions ranging from no pain/very happy (0) to crying/hurts worst (10). Higher scores indicate a lower pain tolerance. In this study, this scale is evaluated using personal reports and records from children, their parents, the researcher, and the nurse after the blood sampling procedure.

    during the procedure

Secondary Outcomes (1)

  • The level of anxiety is evaluated using the Children Anxiety Meter-State

    during the procedure

Study Arms (4)

Pinwheel Group

EXPERIMENTAL

In the pinwheel group, a windmill made of colored cardboard is introduced to the children, and then they are asked to blow on the pinwheel during the blood sampling procedure.The blood sampling is terminated at the same time by blowing the pinwheel.

Other: PFA

Finger Puppet Group

EXPERIMENTAL

In the finger puppet group, a finger puppet made of felt is introduced to the children, and they are told a story (Brave Little Rabbit) by the same researcher using the finger puppet.The blood sampling is terminated at the same time by reading story with finger puppet.

Other: PFA

Abeslang Puzzle Group

EXPERIMENTAL

In the abeslang puzzle group, a puzzle made of colorful abeslang pieces with animal images (sheep, duck) is introduced to the children, and then they are asked to complete the puzzle using their non-dominant hand during the blood sampling procedure.The blood sampling is terminated at the same time by completing abeslang puzzle.

Other: PFA

Control

NO INTERVENTION

Children in the control group are monitored during the blood sampling procedure if their informed consent is obtained by the researcher. They have the routine blood draw procedure, and do not receive any distraction techniques and other pharmacological interventions.

Interventions

PFAOTHER

PFA

Abeslang Puzzle GroupFinger Puppet GroupPinwheel Group

Eligibility Criteria

Age4 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Being between 4-6 years old
  • Referring to the pediatric emergency department
  • Having consent and approval from the parent and child to participate in the study
  • Having a necessity for blood testing in the child.

You may not qualify if:

  • Having visual, hearing, or speech impairment
  • Having chronic or genetic diseases
  • Having intellectual disability
  • Having a history of sedative, narcotic, or analgesic drug use within the past 24 hours
  • Having inflammatory diseases
  • Being classified under the red triage category
  • Unwilling to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fatma Dinç

Bartın, 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.

MeSH Terms

Conditions

Acute PainAnxiety Disorders

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Fatma Dinç, PhD Student

    Bartın Unıversity

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 6, 2023

First Posted

June 15, 2023

Study Start

June 20, 2023

Primary Completion

June 21, 2024

Study Completion

June 21, 2024

Last Updated

June 25, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations