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Effects of Virtual Reality, External Cold and Vibration to Children During IM Injection on Pain, Fear and Anxiety

A

Akdeniz University

Status

Active, not recruiting

Conditions

Fear
Child, Only
Procedural Anxiety
Procedural Pain

Treatments

Behavioral: Local cold-vibration
Behavioral: Virtual Reality

Study type

Interventional

Funder types

Other

Identifiers

NCT05434832
2019/920
5207

Details and patient eligibility

About

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.

Full 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.

Enrollment

117 patients

Sex

All

Ages

5 to 10 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

117 participants in 3 patient groups

Virtual Reality Group
Experimental group
Description:
watching the cartoon by wearing virtual reality glass to the child during the intramuscular injection
Treatment:
Behavioral: Virtual Reality
Local cold-vibration Group
Experimental group
Description:
The local cold-vibration device is placed 5 cm above the area to be injected
Treatment:
Behavioral: Local cold-vibration
Control Group
No Intervention group
Description:
standart care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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