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

NCT ID: NCT05434832

Last Updated: 2022-06-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 117 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-01
• Study Completion Date: 2022-06-27

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.

Conditions

Procedural Pain; Fear; Procedural Anxiety; Child, Only

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Virtual Reality Group

watching the cartoon by wearing virtual reality glass to the child during the intramuscular injection

Group Type: EXPERIMENTAL

Virtual Reality

Intervention Type: BEHAVIORAL

Distraction method

Local cold-vibration Group

The local cold-vibration device is placed 5 cm above the area to be injected

Group Type: EXPERIMENTAL

Local cold-vibration

Intervention Type: BEHAVIORAL

Distraction method

Control Group

standart care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Virtual Reality

Distraction method

Intervention Type: BEHAVIORAL

Local cold-vibration

Distraction method

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Akdeniz University

OTHER

Sponsor Role: lead

Responsible Party

Ozge Denli Ozgen

Nurse

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

AYŞEGÜL İŞLER DALGIÇ, Professor

Role: STUDY_DIRECTOR

Akdeniz University

Locations

Ayşegül İşler Dalgiç

Antalya, Akdeniz University, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

5207

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2019/920

Identifier Type: -

Identifier Source: org_study_id