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The Effect of Virtual Reality Glasses on Pain on Intravenous Cannulatıon in Children

Primary Purpose

Pain, Procedural

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Virtual reality
Sponsored by
Nevsehir Haci Bektas Veli University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain, Procedural focused on measuring distraction, intravenous cannulation, pain, school-aged children, virtual reality glasses

Eligibility Criteria

7 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • between the ages of 7-12,
  • Does not have a disease that causes chronic pain,
  • Not taking any analgesic medication in the last 8 hours before the procedure,
  • No mental or neurological disability,
  • Having no visual or auditory problems that prevent you from applying the scales or watching videos,
  • Does not have eye problems and/or does not use glasses to be able to wear VR glasses,
  • The first vascular access procedure was performed during this hospitalization at the clinic,
  • Vascular access opened on the first try,
  • Speaking and understanding Turkish,
  • Children whose parents and themselves agreed to participate in the study were included in the study.

Exclusion Criteria:

  • Does not understand the Turkish language
  • the child is under 7 years old or 12 years older
  • having vision, hearing or speech problems
  • having a mental or neurological disability

Sites / Locations

  • Bahriye Kaplan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Virtual reality

control group

Arm Description

Virtual reality video application

control group

Outcomes

Primary Outcome Measures

Visual Analog Scale (VAS), Change:
The severity of the pain marked by the child on the scale ranges from 0 to 10. If the severity increases after the procedure, it indicates that the pain increases, and if it decreases, it indicates that the pain decreases.
Faces Pain Scale-Revised (FPS-R), Change:
In the scale consisting of facial expressions, each facial expression has a number equivalent. The severity of pain marked by the child on the scale ranges from 0 to 10. If the severity increases after the procedure, it indicates that the pain increases, and if it decreases, it indicates that the pain decreases.

Secondary Outcome Measures

Physiological parameters
Heart Rate, Change
Physiological parameters
Oxygen saturation, Change

Full Information

First Posted
February 8, 2022
Last Updated
March 1, 2022
Sponsor
Nevsehir Haci Bektas Veli University
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1. Study Identification

Unique Protocol Identification Number
NCT05273866
Brief Title
The Effect of Virtual Reality Glasses on Pain on Intravenous Cannulatıon in Children
Official Title
A Technological Intervention in Pain Control on Intravenous Cannulatıon in Children Virtual Reality Glasses: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
April 29, 2019 (Actual)
Primary Completion Date
August 31, 2019 (Actual)
Study Completion Date
August 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nevsehir Haci Bektas Veli 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
This study was carried out to determine the effect of virtual reality glasses on reducing pain during vascular access in children. The study consisted of 70 children (35 children in the virtual reality video group and 35 children in the control group). Ethics committee approval, permissions from institutions and informed voluntary consent of the children were obtained in order to conduct the study. The data of the study were collected with Child Descriptive Characteristics Form, Parent Descriptive Characteristics Form, Visual Analog Scale (VAS), Revised Facial Expression Pain Scale (FPS-R), Intervention Monitoring Form, Child Behavior Observation Form and Parent Behavior Observation Form. In the study, the children in the experimental group were shown a video with virtual reality glasses during the vascular access procedure. Before and after the study; The child and his parents were asked to evaluate the pain experienced/will experience during the procedure, the children's heart rate, O2 saturation, body temperature were measured, and the behaviors of the child and the parent during the procedure were evaluated. A p value of <0.05 was considered statistically significant in data analysis.
Detailed Description
This randomized controlled experimental study was conducted to determine the effect of virtual reality glasses on reducing pain during vascular access in children. The study was conducted among children aged 7-12 years in a tertiary hospital. Children in the experimental group (n=35) and control group (n=35); Age, gender, class of education, previous hospitalization and vascular access experience criteria were selected similar (p>0.05). Data were collected with Child Descriptive Characteristics Form, Parent Descriptive Characteristics Form, Visual Analog Scale (VAS), Revised Facial Expression Pain Scale (FPS-R), Intervention Monitoring Form, Child Behavior Observation Form, and Parent Behavior Observation Form. In the study, the children in the experimental group were shown a video with virtual reality glasses during the vascular access procedure. Before and after the study; The child and his parents were asked to evaluate the pain experienced/will experience during the procedure, the children's heart rate, O2 saturation, body temperature were measured, and the behaviors of the child and the parent during the procedure were evaluated. Data were used post-power analysis, descriptive statistics, Shapiro Wilk, Pearson chi-square, Mann Whitney U and Two-Related-Samples Tests. A p value of <0.05 was considered statistically significant in data analysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Procedural
Keywords
distraction, intravenous cannulation, pain, school-aged children, virtual reality glasses

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual reality
Arm Type
Experimental
Arm Description
Virtual reality video application
Arm Title
control group
Arm Type
No Intervention
Arm Description
control group
Intervention Type
Other
Intervention Name(s)
Virtual reality
Intervention Description
Virtual Reality video application reduces pain by distracting. The intervention group was watched video during the procedure, starting before the procedure.
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS), Change:
Description
The severity of the pain marked by the child on the scale ranges from 0 to 10. If the severity increases after the procedure, it indicates that the pain increases, and if it decreases, it indicates that the pain decreases.
Time Frame
2 minutes before and 2 minutes after Intravenous Cannulatıon
Title
Faces Pain Scale-Revised (FPS-R), Change:
Description
In the scale consisting of facial expressions, each facial expression has a number equivalent. The severity of pain marked by the child on the scale ranges from 0 to 10. If the severity increases after the procedure, it indicates that the pain increases, and if it decreases, it indicates that the pain decreases.
Time Frame
3 minutes before and 3 minutes after Intravenous Cannulatıon
Secondary Outcome Measure Information:
Title
Physiological parameters
Description
Heart Rate, Change
Time Frame
2 minutes before and 2 minutes after Intravenous Cannulatıon
Title
Physiological parameters
Description
Oxygen saturation, Change
Time Frame
3 minutes before and 3 minutes after Intravenous Cannulatıon

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: between the ages of 7-12, Does not have a disease that causes chronic pain, Not taking any analgesic medication in the last 8 hours before the procedure, No mental or neurological disability, Having no visual or auditory problems that prevent you from applying the scales or watching videos, Does not have eye problems and/or does not use glasses to be able to wear VR glasses, The first vascular access procedure was performed during this hospitalization at the clinic, Vascular access opened on the first try, Speaking and understanding Turkish, Children whose parents and themselves agreed to participate in the study were included in the study. Exclusion Criteria: Does not understand the Turkish language the child is under 7 years old or 12 years older having vision, hearing or speech problems having a mental or neurological disability
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bahriye Kaplan, Doctor
Organizational Affiliation
Nevsehir Haci Bektas Veli University
Official's Role
Study Director
Facility Information:
Facility Name
Bahriye Kaplan
City
Nevşehir
ZIP/Postal Code
50100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Virtual Reality Glasses on Pain on Intravenous Cannulatıon in Children

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