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

The Effect of Virtual Reality Glass and Smartphone Game Application on Preoperative Anxiety in 7-13 Years Children

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.

Study Overview

• Status: Completed
• Conditions: Preoperative Anxiety
• Intervention / Treatment: Device: Virtual reality; Device: Smartphone

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Melikgazi
    • Kayseri, Melikgazi, Turkey
      • Erciyes University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 13 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Control group
EXPERIMENTAL: Virtual reality glass game application	Device: Virtual reality; 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.
ACTIVE_COMPARATOR: Smartphone game application	Device: Smartphone; The Smartphone game application reduces anxiety by distracting attention. Smartphone game was played to intervention group for 15 minutes before surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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 Measures

Outcome Measure	Measure Description	Time Frame
Physiological parameters	Heart Rate, Change= Half an hour before and, 45 minutes before the operation and 90 minutes after the operation.	One day: One day: 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.	One day: 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.	One day: One day: Half an hour before and, 45 minutes before the operation and 90 minutes after the operation.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Salivary cortisol	Serum biochemical parameters.The high level of salivary cortisol is interpreted as an increase in cortisol secretion.	One day: Half an hour before the operation

Collaborators and Investigators

• Sponsor: TC Erciyes University
• Investigators: Principal Investigator: Nuray Caner, Dr, TC Erciyes University

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2019
• Primary Completion (ACTUAL): July 1, 2019
• Study Completion (ACTUAL): March 1, 2020

Study Registration Dates

• First Submitted: October 8, 2021
• First Submitted That Met QC Criteria: October 26, 2021
• First Posted (ACTUAL): November 5, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 5, 2021
• Last Update Submitted That Met QC Criteria: October 26, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 2018/103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No