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

NCT ID: NCT06246877

Last Updated: 2024-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-12

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Fear of Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

virtual reality applied group

Intervention Type BEHAVIORAL

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.

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.).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ondokuz Mayıs University

OTHER

Sponsor Role lead

Responsible Party

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Esra TURAL BUYUK

Assoc Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ondokuz Mayıs University Faculty of Health Sciences

Samsun, Atakum, Turkey (Türkiye)

Site Status

Bafra State Hospital

Samsun, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Esra TURAL BÜYÜK, pHD

Role: CONTACT

+5052795196

Facility Contacts

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Esra Tural Büyük, pHD

Role: primary

5052795196

Other Identifiers

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K Teli

Identifier Type: -

Identifier Source: org_study_id

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