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

Not Applicable

Completed

• Conditions: Anxiety; Pain
• Interventions: Other: Intervention; Other: Distraction card

• Registration Number: NCT05758584
• Lead Sponsor: Saglik Bilimleri Universitesi

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-01
• Primary Completion: 2022-03-01
• Study Completion: 2022-05-01
• Study First Submitted: 2022-11-09
• Status Verified: 2023-02
• Study First Submitted QC: 2023-02-24
• Last Update Submitted: 2023-02-24
• Study First Posted: 2023-03-07
• Last Update Posted: 2023-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Intervention	Vibrating tourniquet group
Group 2	Distraction card	Distraction cards group

Primary Outcome Measures

Name	Time	Method
change on pain intensity as measured by Visual Analog Scale	"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 Outcome Measures

Name	Time	Method
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	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.
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	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 \[the needle\].

Trial Locations

Locations (1)

University of Health Sciences Turkey; 🇹🇷 Ankara, Turkey