Clinical trial NCT05281133: Effect Of Virtual Reality Glasses Used During Splint Application On Children's Pain And Anxiety Levels.
Official title: Effect Of Virtual Reality Glasses Used During Splint Application On Children's Pain And Anxiety Levels.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Acute
Anxiety Acute
Fractures, Bone
Keywords: Anxiety
child
fracture
nurse
pain
splint
virtual reality glasses
Lead sponsor: Karabuk University
Sponsor class: OTHER
First posted: 2022-03-16
Enrollment: 80
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study was carried out as a randomized controlled. In the study, two groups consisted of experimental group (n=40) and control group (n=40) were determined.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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:

* 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.

Primary outcomes:
measure: Wong Baker Pain Scale- (FACES)
timeFrame: six months
measure: State-Trait Anxiety Inventory for Children- (STAI-CH)
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
city: Karabük
country: Turkey
facility: Institute of Health Sciences Karabuk University
state: Merkez/Turkey
Study officials:
affiliation: Karabuk University
name: Özlem Öztürk Şahin, ass. prof.
role: STUDY_DIRECTOR
References: