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

Primary Purpose

Pain, Anxiety

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Intervention
Distraction card
Sponsored by
Saglik Bilimleri Universitesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pain focused on measuring pain, anxiety, children, nurse, phlebotomy

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Health Sciences Turkey

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Group 1

Group 2

Group 3

Arm Description

Vibrating tourniquet group

Distraction cards group

Control group

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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].

Full Information

First Posted
November 9, 2022
Last Updated
February 24, 2023
Sponsor
Saglik Bilimleri Universitesi
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1. Study Identification

Unique Protocol Identification Number
NCT05758584
Brief Title
Effect of Vibrating Tourniquet and Distraction Cards on Pain and Anxiety in Children
Official Title
Effect of Vibrating Tourniquet and Distraction Cards on Pain and Anxiety Levels During Phlebotomy in Children
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
March 1, 2022 (Actual)
Study Completion Date
May 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saglik Bilimleri Universitesi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Anxiety
Keywords
pain, anxiety, children, nurse, phlebotomy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Vibrating tourniquet group
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Distraction cards group
Arm Title
Group 3
Arm Type
No Intervention
Arm Description
Control group
Intervention Type
Other
Intervention Name(s)
Intervention
Other Intervention Name(s)
Vibrating tourniquet
Intervention Description
Vibrating tourniquet
Intervention Type
Other
Intervention Name(s)
Distraction card
Intervention Description
Distraction card
Primary Outcome Measure Information:
Title
change on pain intensity as measured by Visual Analog Scale
Description
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.
Time Frame
"5-10 minutes before procedure", "during procedure" and "5 minutes after" blood collection process
Secondary Outcome Measure Information:
Title
Score change on state anxiety level as measured by Child Anxiety Scale State Scale (ÇAS-D)
Description
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.
Time Frame
"5-10 minutes before procedure" and "5 minutes after procedure" blood collection process
Title
Score change on fear level as measured by Children's Fear Scale
Description
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].
Time Frame
"5-10 minutes before procedure" and "5 minutes after procedure" blood collection process

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Health Sciences Turkey
City
Ankara
ZIP/Postal Code
06010
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29728296
Citation
Bergomi P, Scudeller L, Pintaldi S, Dal Molin A. Efficacy of Non-pharmacological Methods of Pain Management in Children Undergoing Venipuncture in a Pediatric Outpatient Clinic: A Randomized Controlled Trial of Audiovisual Distraction and External Cold and Vibration. J Pediatr Nurs. 2018 Sep-Oct;42:e66-e72. doi: 10.1016/j.pedn.2018.04.011. Epub 2018 May 1.
Results Reference
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PubMed Identifier
28712986
Citation
Bukola IM, Paula D. The Effectiveness of Distraction as Procedural Pain Management Technique in Pediatric Oncology Patients: A Meta-analysis and Systematic Review. J Pain Symptom Manage. 2017 Oct;54(4):589-600.e1. doi: 10.1016/j.jpainsymman.2017.07.006. Epub 2017 Jul 14.
Results Reference
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PubMed Identifier
29559294
Citation
Gerceker GO, Binay S, Bilsin E, Kahraman A, Yilmaz HB. Effects of Virtual Reality and External Cold and Vibration on Pain in 7- to 12-Year-Old Children During Phlebotomy: A Randomized Controlled Trial. J Perianesth Nurs. 2018 Dec;33(6):981-989. doi: 10.1016/j.jopan.2017.12.010. Epub 2018 Mar 17.
Results Reference
background
PubMed Identifier
33711642
Citation
Diaz-Rodriguez M, Alcantara-Rubio L, Aguilar-Garcia D, Perez-Munoz C, Carretero-Bravo J, Puertas-Cristobal E. The Effect of Play on Pain and Anxiety in Children in the Field of Nursing: A Systematic Review. J Pediatr Nurs. 2021 Nov-Dec;61:15-22. doi: 10.1016/j.pedn.2021.02.022. Epub 2021 Mar 10.
Results Reference
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Effect of Vibrating Tourniquet and Distraction Cards on Pain and Anxiety in Children

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