Clinical trial NCT05435105: Effects of Virtual Reality, Cold-Vibration Due To Intravenous Catheterization on Pain, Fear and Anxiety on Children
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Procedural Anxiety
Fear
Procedural Pain
Child, Only
Keywords: procedural anxiety
fear
procedural pain
peripheral intravenous catheter
virtual reality
local-cold vibration
distraction method
nonpharmacological method
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2022-06-28
Enrollment: 114
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A total of three groups as 2 intervention (virtual reality, local cold-vibration) and control group (routine application)
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Assessing the children's anxiety with Children's State Anxiety
timeFrame: Before the peripheral intravenous catheterization
measure: Assessing the children's anxiety with Children's State Anxiety
timeFrame: Within the first 5 minutes after the peripheral intravenous catheterization
measure: Assessing the children's fear with Child Fear Scale
timeFrame: Before the peripheral intravenous catheterization
measure: Assessing the children's fear with Child Fear Scale
timeFrame: Within the first 5 minutes after the peripheral intravenous catheterization
measure: Assessing the children's pain with Wong-Baker-FACES
timeFrame: Before the peripheral intravenous catheterization
measure: Assessing children's pain with Wong-Baker-FACES
timeFrame: Within the first 5 minutes after the peripheral intravenous catheterization
Secondary outcomes:
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Ayşegül İşler Dalgiç
state: Akdeniz University
Study officials:
affiliation: Akdeniz University
name: AYŞEGÜL İŞLER DALGIÇ, Professor
role: STUDY_DIRECTOR
References: