Virtual Reality on Pain and Fear Level During Kirschner Wires (K-Wires) Removal in Children

Fear of Pain Clinical Trial

Official title:

Effect of Virtual Reality on Pain and Fear Level During Kirschner Wires (K-Wires) Removal and Dressing in Children

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06246877
• Other study ID #: K Teli
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 12, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Ondokuz Mayis University
• Contact: Esra TURAL BÜYÜK, pHD
• Phone: +5052795196
• Email: esratural55[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will be conducted to examine the effect of virtual reality applied during K-wire removal and dressing on the pain and fear levels that develop due to the procedure in children aged 7-12 years who apply to the orthopedic outpatient clinic.

Description:

Technology-based methods have now begun to be used to control anxiety and prevent pain that may occur before, during and after diagnosis and treatment procedures in children.

Virtual reality (VR), which is among the technological products, can be used in non-pharmacological methods as well as pharmacological methods.

It has been observed that VR, especially in children, creates an analgesic effect by mainly distracting the pain centers in the brain and evokes positive emotions with an anxiolytic effect.Since children do not want to see the procedures to be performed on them, virtual reality used during the procedure is one of the methods of diverting attention from the environment they are in. This study will be conducted to examine the effect of virtual reality applied during K-wire removal and dressing on the pain and fear levels that develop due to the procedure in children aged 7-12 years who apply to the orthopedic outpatient clinic.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: December 31, 2024
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 12 Years

Eligibility

Inclusion Criteria:

• Being a child between the ages of 7-12 who will have the K wire removed

• The child is not using glasses

• The child must be at a cognitive development level that can respond to video selection.

Exclusion Criteria:

• Having a disease that causes chronic pain

• The child must have used medication that would have an analgesic effect in the last 24 hours before the application.

• The child is wearing glasses

• The child has a mental or neurological disability

Related Conditions & MeSH terms

• Fear of Pain

Intervention

Behavioral:
• virtual reality applied group
Before the K-wire is removed and dressed, the three-dimensional video that the child likes and wants to watch will be placed on virtual reality glasses and attached to the child. During the procedure, the child will be allowed to watch videos through virtual reality glasses.

Locations

Country	Name	City	State
Turkey	Bafra State Hospital	Samsun
Turkey	Ondokuz Mayis University Faculty of Health Sciences	Samsun	Atakum

Sponsors (1)

Lead Sponsor	Collaborator
Ondokuz Mayis University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wong-Baker Faces Pain Scale	It is suitable for ages three and above. The pain level of the faces on the scale is explained to the child: "Face 0" indicates that there is no pain and is very happy. "Face 2" has some pain. "Face 4" has slightly more pain. "Face 6" has more pain. The pain of "Face 8" is quite severe. The pain of "Face 10" is unbearable.	The "Wong-Baker Faces Pain Scale" will be scored 5 minutes before K-wire removal and dressing. It will be evaluated again by scoring the "Wong-Baker Faces Pain Scale" 5 minutes after the K-wire removal and dressing.
Secondary	Children's Fear Scale	The scale is a scale that evaluates between 0 and 4, consisting of showing five drawn facial expressions ranging from neutral expression (0 = no anxiety) to scared face (4 = severe anxiety).	"Child Fear Scale" scoring will be done 5 minutes before K-wire removal and dressing. It will be evaluated again by scoring the "Child Fear Scale" 5 minutes after the K-wire removal and dressing.