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Clinical Trials/NCT04513873
NCT04513873
Completed
Not Applicable

The Effect Of Diverting The Children's Attention To A Different Point During Phlebotomy On Pain And Anxiety

Afyonkarahisar Health Sciences University1 site in 1 country256 target enrollmentJanuary 18, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain and Anxiety of Children During Phlebotomy
Sponsor
Afyonkarahisar Health Sciences University
Enrollment
256
Locations
1
Primary Endpoint
Assessment of Children's Anxiety Level Change
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

This study aimed to investigate the effect of diverting the children's attention to a different point during phlebotomy which is an invasive procedure with acute pain. This is a randomized controlled experimental study. The study was conducted with two groups: the intervention group (n=127) and the control group (n=129). The control group was applied to standard phlebotomy procedures. In contrast, the intervention group had a piece of equipment that looks like a blood tube in front of them during the phlebotomy process to divert their attention from the phlebotomy process to the equipment.

Detailed Description

The equipment used for the intervention group was designed and developed by the researchers with the project support of TÜBİTAK BİDEB 2209A in 2016. It is an equipment that looks like a blood tube with a fixed arm on the right and a moving arm on the left with a total height of 80 cm. It has some answers to common questions of parents as well as the key concerns of the children " Will it hurt me?"

Registry
clinicaltrials.gov
Start Date
January 18, 2019
End Date
March 28, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Afyonkarahisar Health Sciences University
Responsible Party
Principal Investigator
Principal Investigator

Yeliz Ciğerci

Assistant Professor PhD

Afyonkarahisar Health Sciences University

Eligibility Criteria

Inclusion Criteria

  • making a request for the phlebotomy
  • being in the 7-12 age group
  • having the consent of the parent
  • willing to participate in the research
  • with the history of invasive procedure
  • not using any medication with analgesic effect in the last 12 hours
  • without any communication barriers of either child or the parent
  • with a normal level of consciousness during the process
  • without the history of passing out during the phlebotomy

Exclusion Criteria

  • not being in the 7-12 age group
  • not having the consent of the parent
  • not willing to participate in the research
  • without the history of invasive procedure
  • had medication with analgesic effect in the last 12 hours
  • with communication barriers of either child or the parent
  • with an abnormal level of consciousness during the process
  • with the history of passing out during the phlebotomy

Outcomes

Primary Outcomes

Assessment of Children's Anxiety Level Change

Time Frame: Twice ( Immediately after the procedure and 14 days after the procedure)

Children's Fear Scale is an instrument with five different face images changing from neutral (0= no fear) to most scared (4= with the most fear) to evaluate the scare level of the children during the procedure.

Secondary Outcomes

  • Revised Face Pain Scale (FPS-R)(Twice ( During the procedure and 5-10 minutes after the procedure))

Study Sites (1)

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