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The Effect of Virtual Reality Glass and Smartphone Game Application on Preoperative Anxiety in Children

Primary Purpose

Preoperative Anxiety

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Virtual reality
Smartphone
Sponsored by
TC Erciyes University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Preoperative Anxiety

Eligibility Criteria

7 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Between 7 and 13 years of age
  • Patients scheduled for day surgery
  • Not having vision, hearing or speech problems
  • Understands the Turkish language
  • Not having a mental or neurological disability
  • Not having a history of convulsions

Exclusion Criteria:

  • Does not understand the Turkish language
  • the child is under 7 years old or 13 years older
  • having vision, hearing or speech problems
  • having a mental or neurological disability
  • having a history of convulsions

Sites / Locations

  • Erciyes University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Virtual reality glass game application

Smartphone game application

Control group

Arm Description

Outcomes

Primary Outcome Measures

Children's Perioperative Multidimensional Anxiety Scale (CPMAS) Mean Score
According to the CPMAS, a score between 0-500 is obtained from the scale. A high score from the scale indicates a high level of perioperative anxiety. Change= in preoperative assessment (Time 1), on the day of the operation (Time 2) and one month postoperatively (Time 3).

Secondary Outcome Measures

Physiological parameters
Heart Rate, Change= Half an hour before and, 45 minutes before the operation and 90 minutes after the operation.
Physiological parameters
Oxygen saturation, Change= Half an hour before and, 45 minutes before the operation and 90 minutes after the operation.
Physiological parameters
Blood pressure, Change= Half an hour before and, 45 minutes before the operation and 90 minutes after the operation.

Full Information

First Posted
October 8, 2021
Last Updated
October 26, 2021
Sponsor
TC Erciyes University
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1. Study Identification

Unique Protocol Identification Number
NCT05109767
Brief Title
The Effect of Virtual Reality Glass and Smartphone Game Application on Preoperative Anxiety in Children
Official Title
The Effect of Virtual Reality Glass and Smartphone Game Application on Preoperative Anxiety in 7-13 Years Children
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
July 1, 2019 (Actual)
Study Completion Date
March 1, 2020 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
This study was conducted to evaluate the effects of virtual reality glasses and smartphone game applications on preoperative anxiety in children who have day surgery. The study comprised of 60 children (20 children in a virtual reality glass game application group, 20 children in a smartphone game application group, and 20 children in a control group). The approval of the ethics committee, permissions from the institutions, and informed voluntary approval of the children's were obtained to conduct the research. The data of the research were collected through the Children's Perioperative Multidimensional Anxiety Scale (CPMAS), physiological parameters of children were measured before, after and 90 minutes after the operation, and salivary cortisol sample taken before surgery in all of groups. Children in smartphone game application groups played a game for 15 minutes on a smartphone before the surgical operation, and standard care was given to children. Children in virtual reality game application groups played a game for 15 minutes on virtual reality glasses before the surgical operation, and standard care was given to children. Before the surgical operation, standard care was given to children in control groups. The value of p<0.05 was accepted statistically significant in the data analyses.
Detailed Description
This randomized controlled experimental study was conducted to evaluate the effects of virtual reality glasses and smartphone game applications on preoperative anxiety in children who have day surgery. The study was performed between the ages of 7-13 years children at a tertiary hospital. Age, gender, surgery type, previous hospitalization experience and having chronic disease criteria of the children in control group (n=20), smartphone game application (n=20) and virtual reality glass game application (n=20) groups. Data were collected with Descriptive Characteristics Form for Children and Families, Children's Perioperative Multidimensional Anxiety Scale (CPMAS). Before the surgical operation, the game with a smartphone and virtual reality glass was played to the intervention groups for 15 minutes. Physiological parameters of children were measured before, after and 90 minutes after the operation. In addition, CPMAS was applied to children in preoperative assessment (Time 1), on the day of the operation (Time 2) and one month postoperatively (Time 3). Data were analyzed with post-power analysis, descriptive statistics, Kruskal-Wallis and Friedman Tests. The value of p<0.05 was accepted statistically significant in the data analyses.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preoperative Anxiety

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Virtual reality glass game application
Arm Type
Experimental
Arm Title
Smartphone game application
Arm Type
Active Comparator
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Virtual reality
Intervention Description
The Virtual Reality Glass game application reduces anxiety by distracting attention..The virtual reality glass game was played to intervention group for 15 minutes before surgery.
Intervention Type
Device
Intervention Name(s)
Smartphone
Intervention Description
The Smartphone game application reduces anxiety by distracting attention. Smartphone game was played to intervention group for 15 minutes before surgery.
Primary Outcome Measure Information:
Title
Children's Perioperative Multidimensional Anxiety Scale (CPMAS) Mean Score
Description
According to the CPMAS, a score between 0-500 is obtained from the scale. A high score from the scale indicates a high level of perioperative anxiety. Change= in preoperative assessment (Time 1), on the day of the operation (Time 2) and one month postoperatively (Time 3).
Time Frame
An average of 45 days: In preoperative assessment (Time 1), on the day of the operation (Time 2) and one month postoperatively (Time 3).
Secondary Outcome Measure Information:
Title
Physiological parameters
Description
Heart Rate, Change= Half an hour before and, 45 minutes before the operation and 90 minutes after the operation.
Time Frame
One day: One day: Half an hour before and, 45 minutes before the operation and 90 minutes after the operation.
Title
Physiological parameters
Description
Oxygen saturation, Change= Half an hour before and, 45 minutes before the operation and 90 minutes after the operation.
Time Frame
One day: Half an hour before and, 45 minutes before the operation and 90 minutes after the operation.
Title
Physiological parameters
Description
Blood pressure, Change= Half an hour before and, 45 minutes before the operation and 90 minutes after the operation.
Time Frame
One day: One day: Half an hour before and, 45 minutes before the operation and 90 minutes after the operation.
Other Pre-specified Outcome Measures:
Title
Salivary cortisol
Description
Serum biochemical parameters.The high level of salivary cortisol is interpreted as an increase in cortisol secretion.
Time Frame
One day: Half an hour before the operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Between 7 and 13 years of age Patients scheduled for day surgery Not having vision, hearing or speech problems Understands the Turkish language Not having a mental or neurological disability Not having a history of convulsions Exclusion Criteria: Does not understand the Turkish language the child is under 7 years old or 13 years older having vision, hearing or speech problems having a mental or neurological disability having a history of convulsions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nuray Caner, Dr
Organizational Affiliation
TC Erciyes University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Erciyes University
City
Kayseri
State/Province
Melikgazi
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Virtual Reality Glass and Smartphone Game Application on Preoperative Anxiety in Children

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