ClinicalTrials.gg
CompletedNCT05281133Updated Mar 16, 2022

Effect Of Virtual Reality Glasses Used During Splint Application On Children's Pain And Anxiety Levels.

An interventional study of The group using virtual reality glasses in Pain, Acute, Anxiety Acute and Fractures, Bone, sponsored by Karabuk University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2022-03-16.

Sponsored by Karabuk University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled May 2021, registered Mar 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
6 Years to 12 Years
Sex
All
01

Study summary

The study in order to evaluate the effect of virtual reality glasses during splint in children on pain and anxiety due to the procedure.

Read the detailed description

The study was carried out as a randomized controlled experimental study in order to evaluate the effect of virtual reality glasses during splint in children aged 6-12 years on pain and anxiety due to the procedure.

The sample of the research consisted of 80 childrens who came to Karabuk University Training and Research Hospital orthopedic policlinic and emergency between 1 May and 31 October 2021 for the splint application. In the study, two groups consisted of experimental group (n=40) and control group (n=40) were determined.

The "Participant Information Form", the "Wong Baker Pain Scale", the "State Anxiety Inventory for Children", virtual reality glasses and pulse oximeter were used to collect data. The pain, anxiety and vital signs of the children in the experimental and control groups were recorded before, during and after the splint.

The video chosen by the children in the experimental group was shown with virtual reality glasses during the splint application. In the control group a video wasn't shown during the splint application. Chi square, Mann Whitney U, Bonferroni and Friedman tests were used in the analysis of data.

02

Conditions studied

  • Pain, Acute
  • Anxiety Acute
  • Fractures, Bone

Keywords

  • Anxiety
  • child
  • fracture
  • nurse
  • pain
  • splint
  • virtual reality glasses
03

In context

Acute Pain

908 studies on the registry are indexed under Acute Pain; 154 are open to participants now.

This study's enrollment of 80 is close to the median of 87 across 759 interventional studies indexed under Acute Pain.

Browse Acute Pain studies →

Lead sponsor

Karabuk University is the lead sponsor of 131 studies on the registry; 30 are open to participants now.

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

04

Who can participate

Ages eligible
6 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • The child should be between the ages of 6 and 12 age old.
  • Acceptance of the research and giving written consent by the family and the child.
  • Ability of the family and child to speak Turkish.
  • The child should not wear glasses.
  • The child should be at a cognitive level able to choose videos.

Exclusion criteria

Exclusion Criteria:

  • The child should have chronic diseases.
  • The child should take analgesics with in the last 24 hours.
  • The child should have physical, mental and neurological disabilities.
  • The child has a febrile illness.
  • Fainting of the child during the procedure.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    The group using virtual reality glasses

    The video chosen by the children in the experimental group was started 1-2 minutes before the splint with virtual reality glasses and watched for an average of 7 minutes.

    Other: The group using virtual reality glasses

  • No intervention
    The group not using virtual reality glasses

    In the control group, during the splint a video was not watched.

Interventions

  • OtherThe group using virtual reality glasses

    The video chosen by the children in the experimental group was started 1-2 minutes before the splint with virtual reality glasses and watched for an average of 7 minutes.

06

What researchers measure

Primary outcomes

  1. Wong Baker Pain Scale- (FACES)

    Wong Baker Faces Pain Rating Scale was developed by Wong and Baker (1981) and was reorganized in 1983. It is employed in the diagnosis of pain severity in 3e18 years-old children. It includes a zero (0) to five (5) scoring system. It is a horizontal scale of 6 hand-drawn faces, from 0 to 5, that range from a smiling "no hurt" face on the left followed by "hurts little bit", "hurts little more", "hurts even more", "hurts whole lot" to a crying "hurts worst" face on the right and scoring is conducted according to the image.

    Time frame: six months

  2. State-Trait Anxiety Inventory for Children- (STAI-CH)

    State-Trait Anxiety Inventory for Children is the scale developed Spielberg's (1966) for testing anxiety. Children are asked to assess how they feel at the moment and to mark the most appropriate option. For each of the 20 items to evaluate the level of anxiety, one of the options (scored as 1, 2 or 3) is marked according to the presence and severity of the symptom. Turkish adaptation, validity and reliability study of this scale was done by Şeniz Özusta (1993). The scale, which consists of twenty items, aims to evaluate the emotions associated with state anxiety such as tension, nervousness, perturbation, and haste. When the presence of these emotions is reported as "very much so" by the child, the highest score is 3 and the lowest score of 1is assigned when "not at all" is preferred. The highest score in the scale is 60 and the lowest score is 20.

    Time frame: six months

07

Study locations

1 site
  • Institute of Health Sciences Karabuk University
    Karabük, Merkez/Turkey 78050, Turkey (Türkiye)
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 16, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05281133
Lead sponsor
Karabuk University
Responsible party
Çağla Kaya (Principal Investigator, Karabuk University) — Principal investigator
First posted
Mar 16, 2022
Start date
May 1, 2021
Primary completion
Oct 31, 2021
Completion
Oct 31, 2021
Last update
Mar 16, 2022

Study contacts

Özlem Öztürk Şahin, ass. prof.
study director · Karabuk University

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 completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion