NCT06352021

Brief Summary

This experimental study aimed to determine the effect of distracting children with a kaleidoscope during blood sampling on their perception of pain during the procedure and to increase and improve the quality of evidence for the effectiveness of these methods across different populations and cultures. Hypothesis 0 (H0): There is no difference between the pain scores of the kaleidoscope group and the control group during blood sampling. Hypothesis 1 (H1): There is a difference between the pain scores of the kaleidoscope group and the control group during blood sampling.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable pain

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

Study Start

First participant enrolled

May 30, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

March 17, 2024

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 8, 2024

Completed
Last Updated

April 8, 2024

Status Verified

April 1, 2024

Enrollment Period

1 month

First QC Date

March 17, 2024

Last Update Submit

April 1, 2024

Conditions

Pain

Keywords

Blood collectionDistractionNon-pharmacological treatmentPainSchoolchild

Outcome Measures

Primary Outcomes (1)

  • The Wong-Baker Pain Scale

    The scale was developed by Wong and Baker (1981) to assess pain between the ages of 3-18 years. It has been reported in the literature that it accurately measures children's pain. The scale has numerical values according to each facial expression. The lowest and the highest values are 0 and 5. As the score on the scale increases, sensitivity to pain decreases, and as the score decreases, sensitivity increases.

    5 minutes

Study Arms (2)

kaleidoscope group

EXPERIMENTAL

The children in the kaleidoscope group were shown the kaleidoscope by the researcher five minutes before the blood sampling, and they were encouraged to look at the kaleidoscope during the procedure and describe the patterns they saw.

Device: kaleidoscope

control group

NO INTERVENTION

This group underwent routine blood sampling procedures and did not receive any intervention to reduce their pain.

Interventions

kaleidoscopeDEVICE

The children in the kaleidoscope group were shown the kaleidoscope by the researcher five minutes before the blood sampling, and they were encouraged to look at the kaleidoscope during the procedure and describe the patterns they saw. All children in the Kaleidoscope group agreed to participate in the study. All children in the kaleidoscope group were asked to look at the kaleidoscope just before the tourniquet was placed on their arms before the blood sampling procedure and to describe the patterns, they saw in it by turning it slowly during the procedure.

kaleidoscope group

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • were being 7-12 years of age
  • not having an auditory or visual disability
  • not taking analgesics in the last eight hours
  • not having any pain caused by other reasons before the procedure
  • having vascular access and blood sampling interventions

You may not qualify if:

  • having physical or mental disability
  • having any nerve damage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karadeniz Technical University Health Application and Research Center Farabi Hospital

Trabzon, 61080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ilknur Kahriman, Assoc. Prof.

    Karadeniz Technical University

    STUDY DIRECTOR

  • Beyhan Turkan, Master

    TRABZON KANUNI EDUCATION RESEARCH HOSPITAL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 17, 2024

First Posted

April 8, 2024

Study Start

May 30, 2019

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

April 8, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)