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

NCT ID: NCT05435105

Last Updated: 2022-06-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-01
• Study Completion Date: 2022-06-27

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.

Conditions

Procedural Anxiety; Fear; Procedural Pain; 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 peripheral intravenous catheterization

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 just before peripheral intravenous catheterization

Group Type: EXPERIMENTAL

Local cold-vibration

Intervention Type: BEHAVIORAL

Distraction method

Control Group

Routine 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;

• 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)

• 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

Berfu Atalay

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

5208

Identifier Type: OTHER

Identifier Source: secondary_id

2019/881

Identifier Type: -

Identifier Source: org_study_id