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Not yet recruitingNCT06246877Updated Feb 9, 2024

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

An interventional study of virtual reality applied group in Fear of Pain, sponsored by Ondokuz Mayıs University. Not yet recruiting at 2 sites in Turkey. Open to participants aged 7 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-09.

Sponsored by Ondokuz Mayıs University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Oct 2024, 1 year 11 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
7 Years to 12 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Fear of Pain

Keywords

  • child
  • Kirschner Wires
  • pain
  • fear
  • Virtual reality
03

In context

Lead sponsor

Ondokuz Mayıs University is the lead sponsor of 262 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
70 participants (estimated)

Study arms

  • 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

  • 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.).

Interventions

  • Behavioralvirtual 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.

06

What researchers measure

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.

    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.

Secondary outcomes

  1. 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).

    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.

07

Study locations

2 sites
  • Ondokuz Mayıs University Faculty of Health Sciences
    Samsun, Atakum 55200, Turkey
  • Bafra State Hospital
    Samsun, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06246877
Lead sponsor
Ondokuz Mayıs University
Responsible party
Esra TURAL BUYUK (Assoc Prof, Ondokuz Mayıs University) — Principal investigator
First posted
Feb 7, 2024
Start date
Feb 12, 2024 (estimated)
Primary completion
Oct 30, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Feb 9, 2024

Study contacts

Esra TURAL BÜYÜK, pHD
Contact
esratural55@gmail.com
+5052795196

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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