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

Study Overview
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Brief Summary
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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.

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

Conditions
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Pain, Anxiety

Intervention / Treatment
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* Other: Intervention
* Other: Distraction card


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized controlled study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Vibrating tourniquet group | Other: Intervention<br>* Vibrating tourniquet<br>* Other names: Vibrating tourniquet;|
| Experimental: Group 2<br>Distraction cards group | Other: Distraction card<br>* Distraction card<br>|
| No Intervention: Group 3<br>Control group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change on pain intensity as measured by Visual Analog Scale | 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. | 5-10 minutes before procedure, during procedure and 5 minutes after blood collection process | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score change on state anxiety level as measured by Child Anxiety Scale State Scale (ÇAS-D) | 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. | 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 | 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]. | 5-10 minutes before procedure and 5 minutes after procedure blood collection process | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, anxiety, children, nurse, phlebotomy