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

February 7, 2024 updated by: Esra TURAL BUYUK, Ondokuz Mayıs University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Samsun, Turkey
        • Bafra State Hospital
    • Atakum
      • Samsun, Atakum, Turkey, 55200
        • Ondokuz Mayıs University Faculty of Health Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
No Intervention: control group
During the removal and dressing of the wire, the child's attention will be diverted by asking some questions (where she lives, the name of the school she attends, what grade she attends, etc.).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wong-Baker Faces Pain Scale
Time Frame: 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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Children's Fear Scale
Time Frame: "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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ondokuz Mayıs University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 12, 2024

Primary Completion (Estimated)

October 30, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

January 30, 2024

First Submitted That Met QC Criteria

January 30, 2024

First Posted (Actual)

February 7, 2024

Study Record Updates

Last Update Posted (Estimated)

February 9, 2024

Last Update Submitted That Met QC Criteria

February 7, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • K Teli

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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