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

NCT ID: NCT05281133

Last Updated: 2022-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-01

Study Completion Date

2021-10-31

Brief Summary

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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

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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.

Conditions

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Pain, Acute Anxiety Acute Fractures, Bone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
A total of 80 children assigned by randomization method (experimental group=40, control group= 40) were included in the sample group. The "Participant Information Form", the "Practice Registration Form", the "Wong Baker Pain Scale", the "State Anxiety Inventory for Children", the "After Splint Child's General Condition Evaluation Form", virtual reality glasses and pulse oximeter were used to collect data by outcomes assessor. 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 started 1-2 minutes before the splint with virtual reality glasses and watched for an average of 7 minutes. In the control group, during the splint a video was not watched.

Study Groups

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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.

Group Type EXPERIMENTAL

The group using virtual reality glasses

Intervention Type 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.

The group not using virtual reality glasses

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karabuk University

OTHER

Sponsor Role lead

Responsible Party

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Çağla Kaya

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Özlem Öztürk Şahin, ass. prof.

Role: STUDY_DIRECTOR

Karabuk University

Locations

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Institute of Health Sciences Karabuk University

Karabük, Merkez/Turkey, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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KBU-SBE-CK-01

Identifier Type: -

Identifier Source: org_study_id

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