Clincosm LogoSign in Get a demo

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

Sponsor
Saglik Bilimleri Universitesi (Other)
Overall Status
Completed
CT.gov ID
NCT05758584
Collaborator
(none)
120
Enrollment
1
Location
3
Arms
10
Actual Duration (Months)
12
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Intervention
  • Other: Distraction card
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
randomized controlled studyrandomized controlled study
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Effect of Vibrating Tourniquet and Distraction Cards on Pain and Anxiety Levels During Phlebotomy in Children
Actual Study Start Date :
Jul 1, 2021
Actual Primary Completion Date :
Mar 1, 2022
Actual Study Completion Date :
May 1, 2022

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. 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].

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 12 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Health Sciences Turkey Ankara Turkey 06010

    Sponsors and Collaborators

    • Saglik Bilimleri Universitesi

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Hümeyra Erdem, Register Nurse, Saglik Bilimleri Universitesi
    ClinicalTrials.gov Identifier:
    NCT05758584
    Other Study ID Numbers:
    • pain_fear_anxiety...///
    First Posted:
    Mar 7, 2023
    Last Update Posted:
    Mar 7, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Hümeyra Erdem, Register Nurse, Saglik Bilimleri Universitesi
    pain
    anxiety
    children
    nurse
    phlebotomy
    Additional relevant MeSH terms:
    Anxiety Disorders

    Study Results

    No Results Posted as of Mar 7, 2023