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

Primary Purpose

Pain, Acute, Anxiety Acute, Fractures, Bone

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
The group using virtual reality glasses
Sponsored by
Karabuk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Acute focused on measuring Anxiety, child, fracture, nurse, pain, splint, virtual reality glasses

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Institute of Health Sciences Karabuk University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

The group using virtual reality glasses

The group not using virtual reality glasses

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 2, 2022
Last Updated
March 10, 2022
Sponsor
Karabuk University
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1. Study Identification

Unique Protocol Identification Number
NCT05281133
Brief Title
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
October 31, 2021 (Actual)
Study Completion Date
October 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karabuk University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute, Anxiety Acute, Fractures, Bone
Keywords
Anxiety, child, fracture, nurse, pain, splint, virtual reality glasses

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The group using virtual reality glasses
Arm Type
Experimental
Arm Description
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.
Arm Title
The group not using virtual reality glasses
Arm Type
No Intervention
Arm Description
In the control group, during the splint a video was not watched.
Intervention Type
Other
Intervention Name(s)
The group using virtual reality glasses
Intervention Description
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 Outcome Measure Information:
Title
Wong Baker Pain Scale- (FACES)
Description
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
Title
State-Trait Anxiety Inventory for Children- (STAI-CH)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Özlem Öztürk Şahin, ass. prof.
Organizational Affiliation
Karabuk University
Official's Role
Study Director
Facility Information:
Facility Name
Institute of Health Sciences Karabuk University
City
Karabük
State/Province
Merkez/Turkey
ZIP/Postal Code
78050
Country
Turkey

12. IPD Sharing Statement

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