Effect Of Virtual Reality Glasses Used… | Clinical Trial

Key information

Conditions

Pain, Acute Acute Pain Anxiety Acute Anxiety Disorders Fractures, Bone Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Wounds and Injuries

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Health Sciences Karabuk University

Karabük, Merkez/Turkey, 78050, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

The group using virtual reality glasses

Other

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.

Primary outcomes

Wong Baker Pain Scale- (FACES)

Time frame: six months

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

Time frame: six months

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.

Sponsors and collaborators

Lead sponsor

Karabuk University

Other

Registry information

Important dates

Study start: 2021
Primary completion: 2021
Study completion: 2021
First posted: Mar 16, 2022
Registry last updated: Mar 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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