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

Not Applicable

• Conditions: Child, Only; Fear; Procedural Pain; Procedural Anxiety
• Interventions: Behavioral: Local cold-vibration; Behavioral: Virtual reality

• Registration Number: NCT05435105
• Lead Sponsor: Akdeniz University

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.

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 Timeline

• Study Start: 2019-06-01
• Primary Completion: 2021-12-27
• Status Verified: 2022-06
• Study First Submitted: 2022-06-17
• Study First Submitted QC: 2022-06-22
• Last Update Submitted: 2022-06-22
• Study Completion: 2022-06-27
• Study First Posted: 2022-06-28
• Last Update Posted: 2022-06-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 114

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Local Cold-Vibration Group	Local cold-vibration	The local cold-vibration device is placed 5 cm above the area just before peripheral intravenous catheterization
Virtual Reality Group	Virtual reality	Watching the cartoon by wearing virtual reality glass to the child during the peripheral intravenous catheterization

Primary Outcome Measures

Name	Time	Method
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).
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 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

Trial Locations

Locations (1)

Ayşegül İşler Dalgiç; 🇹🇷 Antalya, Akdeniz University, Turkey