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Effects of Virtual Reality, Cold-Vibration Due To Intravenous Catheterization on Pain, Fear and Anxiety on Children

A

Akdeniz University

Status

Active, not recruiting

Conditions

Fear
Child, Only
Procedural Anxiety
Procedural Pain

Treatments

Behavioral: Virtual reality
Behavioral: Local cold-vibration

Study type

Interventional

Funder types

Other

Identifiers

NCT05435105
5208 (Other Identifier)
2019/881

Details and patient eligibility

About

This is a randomized controlled trial. The aim of the study is to the effects of Virtual Reality and Local Cold-Vibration applications in reducing anxiety, fear and pain due to intravenous catheterization (PIC) in children aged 5-10 years. PIC was found to be effective in reducing anxiety, fear and pain due to peripheral intravenous catheterization.

Full description

Peripheral intravenous catheterization is an administration method that is frequently used in children and causes pain. There are different non-pharmacological methods for reducing pain due to invasive procedures. The use of non-pharmacological methods is an important part of nursing care to reduce the short and long-term negative effects of painful interventions on children.This study was planned to compare the effectiveness of virtual reality and local cold-vibration applications in reducing anxiety, fear and pain caused by PIC in children aged 5-10 years. It was planned as a randomized controlled experimental study in pre-test, post-test design. The sample of the study was carried out in the Pediatric Emergency Unit of Akdeniz University Medical Faculty Hospital. The applicant will consist of 120 children aged 5-10 years. There will be a total of three groups in the research, 2 of which are the intervention group (virtual reality, local cold-vibration) and the control group (routine application). Data will be collected using the "Child-Parent Description Form", "Child Anxiety Scale-State Scale", "Child Fear Scale", "Wong- Baker Faces Pain Scale". Data will be collected before and within the first 5 minutes after IM injection administration. Scales; to be filled in separately by the child, one of the parents, and the nurse administering the PIC. As a result of this study, it was concluded that the use of virtual reality glasses and local cold-vibration methods are effective in reducing the pain, anxiety and fear that due to PIC placement in children aged 5-10 years.

Enrollment

114 patients

Sex

All

Ages

5 to 10 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

the child;

  • between the ages of 5-10
  • PIC application will be made
  • No visual, auditory or sensory loss
  • Mental and language deficiencies
  • Those who have not taken any analgesic medication in the last 4 hours
  • Do not have a chronic disease (such as oncological diseases, chronic kidney failure) that causes repeated admissions or hospitalizations to the hospital.

Exclusion criteria

  • Unsuccessful PIC application in the first time
  • The child in the group with local cold-vibration application removes the device during the procedure (PIC application).
  • The child in the group in which virtual reality was applied, removing the virtual reality glasses during the procedure (PIC application).
  • Suspecting 'Covid 19' (having any of the symptoms such as fever, cough, respiratory distress, chest pain, loss of taste and smell, sore throat)

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

114 participants in 3 patient groups

Virtual Reality Group
Experimental group
Description:
Watching the cartoon by wearing virtual reality glass to the child during the peripheral intravenous catheterization
Treatment:
Behavioral: Virtual reality
Local Cold-Vibration Group
Experimental group
Description:
The local cold-vibration device is placed 5 cm above the area just before peripheral intravenous catheterization
Treatment:
Behavioral: Local cold-vibration
Control Group
No Intervention group
Description:
Routine Care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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