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Clinical Trials/NCT05758584
NCT05758584
Completed
Not Applicable

Effect of Vibrating Tourniquet and Distraction Cards on Pain and Anxiety Levels During Phlebotomy in Children

Saglik Bilimleri Universitesi1 site in 1 country120 target enrollmentJuly 1, 2021
ConditionsPainAnxiety

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain
Sponsor
Saglik Bilimleri Universitesi
Enrollment
120
Locations
1
Primary Endpoint
change on pain intensity as measured by Visual Analog Scale
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The aim of the study was to observe the effect of the use of vibrating tourniquet and distraction card on the pain, fear and anxiety levels felt during the blood collection process in children. The study was conducted between July 2021 and March 2022 as a randomized controlled study with totally 120 children in three groups. The 'Child and Parent Identification Form' was used for socio-demographic data about the child and the parent before phlebotomy. The 'Visual Analog Scale (VAS)', 'Child Fear Scale (CFS)' and 'Child Anxiety Scale-State Scale (ÇAS-D)' were used before, during and after the phlebotomy. Vibrating Tourniquet Group (intervention group 1) consists of a total of 40 children. Distraction Cards Group (intervention group 2) consists of a total of 40 children. Control group consists of a total of 40 children.

Registry
clinicaltrials.gov
Start Date
July 1, 2021
End Date
May 1, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hümeyra Erdem

Register Nurse

Saglik Bilimleri Universitesi

Eligibility Criteria

Inclusion Criteria

  • The child is between the ages of 6-10,
  • The child has no pain just before the procedure,
  • The child has not taken any analgesic-effective medication in the last 6 hours,
  • The child does not have a hearing problem,
  • The child and the parent can speak and understand Turkish
  • The child has a sufficient level of mental development to understand speech -Parent and child are willing to participate in the research.

Exclusion Criteria

  • Children who cannot be successfully drawn in the first application
  • Children with oncological disease, epilepsy, migraine, or vestibular disorder.

Outcomes

Primary Outcomes

change on pain intensity as measured by Visual Analog Scale

Time Frame: "5-10 minutes before procedure", "during procedure" and "5 minutes after" blood collection process

It is a 10 cm or 100 mm long horizontal or vertical line with anchor statements "no pain or pain at its least" at the left-most end and "unbearable pain or worst pain imaginable" at the right-most end. The VAS score is determined by measuring (in cm) the distance of the mark from the left end of the line.

Secondary Outcomes

  • Score change on state anxiety level as measured by Child Anxiety Scale State Scale (ÇAS-D)("5-10 minutes before procedure" and "5 minutes after procedure" blood collection process)
  • Score change on fear level as measured by Children's Fear Scale("5-10 minutes before procedure" and "5 minutes after procedure" blood collection process)

Study Sites (1)

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