- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06352021
The Effect of Distraction With a Kaleidoscope on the Level of Perceived Pain During Blood Sampling in Children
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.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Trabzon, Turkey, 61080
- Karadeniz Technical University Health Application and Research Center Farabi Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- having physical or mental disability
- having any nerve damage
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: kaleidoscope group
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.
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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.
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No Intervention: control group
This group underwent routine blood sampling procedures and did not receive any intervention to reduce their pain.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Wong-Baker Pain Scale
Time Frame: 5 minutes
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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.
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5 minutes
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Ilknur Kahriman, Assoc. Prof., Karadeniz Technical University
- Principal Investigator: Beyhan Turkan, Master, TRABZON KANUNI EDUCATION RESEARCH HOSPITAL
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- KAHRİMAN İlknur
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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