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

The Effect of Virtual Reality and Local Cold-Vibration Methods on Reducing Anxiety, Fear and Pain Due to Peripheral Intravenous Catheterization in Children

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Fear; Child, Only; Procedural Pain; Procedural Anxiety
• Intervention / Treatment: Behavioral: Virtual reality; Behavioral: Local cold-vibration

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 114
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Akdeniz University
    • Antalya, Akdeniz University, Turkey, 07058
      • Aysegul ISLER DALGIC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessing the children's anxiety with Children's State Anxiety	The Children's State Anxiety (CAS-S). The CAS-S assesses children's anxiety and uses before medical procedures. This scale is drawn like a thermometer with a bulb at the bottom and also includes horizontal lines at intervals going up to the top (0-10). This scale ranges from 0 to 10. Higher values represent higher anxiety	Before the peripheral intravenous catheterization
Assessing the children's anxiety with Children's State Anxiety	The Children's State Anxiety (CAS-S). The CAS-S assesses children's anxiety and uses before medical procedures. This scale is drawn like a thermometer with a bulb at the bottom and also includes horizontal lines at intervals going up to the top (0-10). This scale ranges from 0 to 10. Higher values represent higher anxiety	Within the first 5 minutes after the peripheral intravenous catheterization
Assessing the children's fear with Child Fear Scale	The Child Fear Scale (CFS). The Child Fear Scale will use.This one-item scale measures procedure-related fear in children, consists of five sex-neutral faces, ranges from 0 (no fear) to extreme fear. This rating scale ranges from 0 to 4. It ranges from a no fear (neutral) face (0) on the far left to a face showing extreme fear on the far right. Higher scores mean a worse outcome. The rater responds indicates the level of fear.	Before the peripheral intravenous catheterization
Assessing the children's fear with Child Fear Scale	The Child Fear Scale (CFS). The Child Fear Scale will use.This one-item scale measures procedure-related fear in children, consists of five sex-neutral faces, ranges from 0 (no fear) to extreme fear. This rating scale ranges from 0 to 4. It ranges from a no fear (neutral) face (0) on the far left to a face showing extreme fear on the far right. Higher scores mean a worse outcome. The rater responds indicates the level of fear.	Within the first 5 minutes after the peripheral intravenous catheterization
Assessing the children's pain with Wong-Baker-FACES	Wong-Baker FACES (WB-FACES) Pain Rating Scale used. This scale uses in children aged 3 and older to rate pain severity. This numeric rating scale ranges from 0 to 10. Faces show emotions from smiling (0 = very happy/ no pain) to crying (10 = hurts worst).	Before the peripheral intravenous catheterization
Assessing children's pain with Wong-Baker-FACES	Wong-Baker FACES (WB-FACES) Pain Rating Scale used. This scale uses in children aged 3 and older to rate pain severity. This numeric rating scale ranges from 0 to 10. Faces show emotions from smiling (0 = very happy/ no pain) to crying (10 = hurts worst).	Within the first 5 minutes after the peripheral intravenous catheterization

Collaborators and Investigators

• Sponsor: Akdeniz University
• Investigators: Study Director: Aysegul ISLER DALGIC, Professor, Akdeniz University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Actual): December 27, 2021
• Study Completion (Anticipated): June 27, 2022

Study Registration Dates

• First Submitted: June 17, 2022
• First Submitted That Met QC Criteria: June 22, 2022
• First Posted (Actual): June 28, 2022

Study Record Updates

• Last Update Posted (Actual): June 28, 2022
• Last Update Submitted That Met QC Criteria: June 22, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: virtual reality; fear; procedural pain; procedural anxiety; peripheral intravenous catheter; local-cold vibration; distraction method; nonpharmacological method
• Additional Relevant MeSH Terms: Mental Disorders; Pain; Neurologic Manifestations; Anxiety Disorders; Pain, Procedural
• Other Study ID Numbers: 2019/881; 5208 (Other Identifier: AkdenizU Scientific Research Projects Coordination Unit)

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