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

NCT06246877 | Not Yet Recruiting

• 1 other identifier: K Teli
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Fear of Pain

Keywords

child; Kirschner Wires; pain; fear; Virtual reality

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Children's Fear Scale

  "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.

Study Arms (2)

virtual reality applied group

EXPERIMENTAL

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

control group

NO INTERVENTION

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.).

Interventions

virtual reality applied group 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.

virtual reality applied group

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (2)

Ondokuz Mayıs University Faculty of Health Sciences

Samsun, Atakum, 55200, Turkey (Türkiye)

Location

Bafra State Hospital

Samsun, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Esra TURAL BÜYÜK, pHD

CONTACT

+5052795196; esratural55@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 7, 2024
• Study Start: February 12, 2024
• Primary Completion: October 30, 2024
• Study Completion: December 31, 2024
• Last Updated: February 9, 2024

Record last verified: 2024-02

Locations

TU (2)