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

NCT05109767 | Completed

• 1 other identifier: 2018/103
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Preoperative Anxiety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Physiological parameters

  One day: One day: Half an hour before and, 45 minutes before the operation and 90 minutes after the operation.

• Physiological parameters

  One day: Half an hour before and, 45 minutes before the operation and 90 minutes after the operation.

• Physiological parameters

  One day: One day: Half an hour before and, 45 minutes before the operation and 90 minutes after the operation.

Other Outcomes (1)

• Salivary cortisol

  One day: Half an hour before the operation

Study Arms (3)

Virtual reality glass game application

EXPERIMENTAL

Device: Virtual reality

Smartphone game application

ACTIVE COMPARATOR

Device: Smartphone

Control group

NO INTERVENTION

Interventions

Virtual reality DEVICE

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.

Virtual reality glass game application

Smartphone DEVICE

The Smartphone game application reduces anxiety by distracting attention. Smartphone game was played to intervention group for 15 minutes before surgery.

Smartphone game application

Eligibility Criteria

• Age: 7 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes University

Kayseri, Melikgazi, Turkey (Türkiye)

Location

Study Officials

• Nuray Caner, Dr

  TC Erciyes University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: October 8, 2021
• First Posted: November 5, 2021
• Study Start: July 1, 2019
• Primary Completion: July 1, 2019
• Study Completion: March 1, 2020
• Last Updated: November 5, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)