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Completed

NCT Number: NCT05758584

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

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.

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Key information

Conditions

Pain Anxiety Anxiety Disorders Mental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Health Sciences Turkey

Ankara, 06010, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intervention

Other

Vibrating tourniquet

Other names: Vibrating tourniquet

distraction card

Other

Distraction card

Primary outcomes

  1. 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

  1. Score change on state anxiety level as measured by Child Anxiety Scale State Scale (ÇAS-D)

    Time frame: "5-10 minutes before procedure" and "5 minutes after procedure" blood collection process

    The scale is in the form of a thermometer with horizontal lines. For 10 horizontal lines, the line at the bottom of the thermometer, '0', represents the lowest anxiety level, and the line at the top of the thermometer, i.e., '10', represents the highest level of anxiety.

  2. Score change on fear level as measured by Children's Fear Scale

    Time frame: "5-10 minutes before procedure" and "5 minutes after procedure" blood collection process

    These faces are showing different levels of anxiety. This face [point to the left-most face] shows no anxiety at all, this faces shows a little bit more [point to second face from left], a bit more [sweep finger along scale], right up to extreme anxiety [point to the last face on the right]. Have a look at these faces and choose the one that shows how much anxiety you felt during [the needle].

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 7, 2023
Registry last updated
Mar 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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