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

Sponsor

Akdeniz University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05435105

Collaborator

(none)

114

Enrollment

Location

Arms

36.9

Anticipated Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Procedural Anxiety Fear Procedural Pain Child, Only	Behavioral: Virtual reality Behavioral: Local cold-vibration	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

114 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A total of three groups as 2 intervention (virtual reality, local cold-vibration) and control group (routine application)A total of three groups as 2 intervention (virtual reality, local cold-vibration) and control group (routine application)

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jun 1, 2019

Actual Primary Completion Date :

Dec 27, 2021

Anticipated Study Completion Date :

Jun 27, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Assessing the children's anxiety with Children's State Anxiety [Before the peripheral intravenous catheterization]
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
Assessing the children's anxiety with Children's State Anxiety [Within the first 5 minutes after the peripheral intravenous catheterization]
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
Assessing the children's fear with Child Fear Scale [Before the peripheral intravenous catheterization]
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.
Assessing the children's fear with Child Fear Scale [Within the first 5 minutes after the peripheral intravenous catheterization]
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.
Assessing the children's pain with Wong-Baker-FACES [Before the peripheral intravenous catheterization]
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).
Assessing children's pain with Wong-Baker-FACES [Within the first 5 minutes after the peripheral intravenous catheterization]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 10 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)