Clinical trial NCT05434832: Effects of Virtual Reality, External Cold and Vibration to Children During IM Injection on Pain, Fear and Anxiety
Official title: The Effect of Virtual Reality and Local Cold Application-Vibration Methods on Reducing Anxiety, Fear and Pain Developed During Intramuscular Injection in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Procedural Pain
Fear
Procedural Anxiety
Child, Only
Keywords: child
pain
anxiety
fear
intramuscular injection
local cold-vibration
virtual reality
pediatric nurse
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2022-06-28
Enrollment: 117
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: A randomized controlled trial is conducted to evaluation of the effects of virtual reality and local cold-vibration applications in reducing anxiety, fear and pain due to intramuscular (IM) injection in children aged 5-10 years. It has been determined that the use of Virtual Reality and local cold-vibration are effective interventions in reducing anxiety, fear and pain due to IM injection in children aged 5-10 years.

Detailed description: Intramuscular (IM) intervention is a parenteral administration method that is frequently used in children and causes pain. In cases such as inadequacies in pain management and inability to prevent pain, physiological and psychological problems that can last a lifetime can be seen in the child. 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. However, the use of non-pharmacological methods to reduce the pain perceived by the child during painful interventions in pediatric emergency units is not common in our country. No study has been found in the literature comparing the effectiveness of virtual reality and Buzzy methods in reducing anxiety, fear and pain due to invasive procedures. This study was planned to compare the effectiveness of virtual reality and local cold application-vibration applications in reducing anxiety, fear and pain caused by intramuscular injection 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 Konya Selcuk 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, Buzzy) 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 IM injection. As a result of this study, it was concluded that the use of virtual reality glasses and local cold application-vibration (Buzzy) methods are effective in reducing the pain, anxiety and fear that develop during IM injection in children aged 5-10 years.

Eligibility criteria: Inclusion Criteria:

The child is between the ages of 5 and 10

Having intramuscular (IM) injection therapy

Absence of Audio-Visual-Sensation loss problem

No communication problem

Absence of mental retardation

Absence of a disease causing chronic pain

No history of fainting during injection

Not taking any analgesic medication in the last 4 hours

Exclusion Criteria:

Failure of IM application at one time

The child in the virtual reality application group removes the virtual reality glasses during the IM injection.

The child in the group receiving Buzzy application removes the Buzzy device during IM injection.

Not wanting to fill the scales after the application

Diagnosis or suspicion of COVID-19 (having any of the symptoms such as fever, cough, respiratory distress, chest pain, loss of taste and smell, sore throat, contact with a COVID-19 positive person)

Primary outcomes:
measure: Anxiety assesed by Children's State Anxiety
timeFrame: Before the intramuscular injection
measure: Anxiety assesed by Children's State Anxiety
timeFrame: Within the first 5 minutes after the intramuscular injection
measure: Fear assesed by Child Fear Scale
timeFrame: Before the intramuscular injection
measure: Fear assesed by Child Fear Scale
timeFrame: Within the first 5 minutes after the intramuscular injection
measure: Pain assesed by Wong-Baker FACES
timeFrame: Before the intramuscular injection
measure: Pain assesed by Wong-Baker FACES
timeFrame: Within the first 5 minutes after the intramuscular injection
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: