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

February 24, 2023 updated by: Hümeyra Erdem, Saglik Bilimleri Universitesi

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06010
        • University of Health Sciences Turkey

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
Vibrating tourniquet group
Other: Intervention
Vibrating tourniquet
Other Names:
  • Vibrating tourniquet
Experimental: Group 2
Distraction cards group
Other: Distraction card
Distraction card
No Intervention: Group 3
Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
"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)
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.
"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
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].
"5-10 minutes before procedure" and "5 minutes after procedure" blood collection process

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saglik Bilimleri Universitesi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Actual)

March 1, 2022

Study Completion (Actual)

May 1, 2022

Study Registration Dates

First Submitted

November 9, 2022

First Submitted That Met QC Criteria

February 24, 2023

First Posted (Estimate)

March 7, 2023

Study Record Updates

Last Update Posted (Estimate)

March 7, 2023

Last Update Submitted That Met QC Criteria

February 24, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • pain_fear_anxiety...///

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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