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

Not Applicable

Completed

• Conditions: Preoperative Anxiety
• Interventions: Device: Smartphone; Device: Virtual reality

• Registration Number: NCT05109767
• Lead Sponsor: TC Erciyes University

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.

Study Timeline

• Study Start: 2019-07-01
• Primary Completion: 2019-07-01
• Study Completion: 2020-03-01
• Status Verified: 2021-10
• Study First Submitted: 2021-10-08
• Study First Submitted QC: 2021-10-26
• Last Update Submitted: 2021-10-26
• Study First Posted: 2021-11-05
• Last Update Posted: 2021-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Smartphone game application	Smartphone	-
Virtual reality glass game application	Virtual reality	-

Primary Outcome Measures

Name	Time	Method
Children's Perioperative Multidimensional Anxiety Scale (CPMAS) Mean Score	An average of 45 days: In preoperative assessment (Time 1), on the day of the operation (Time 2) and one month postoperatively (Time 3).	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

Name	Time	Method
Physiological parameters	One day: One day: Half an hour before and, 45 minutes before the operation and 90 minutes after the operation.	Blood pressure, Change= Half an hour before and, 45 minutes before the operation and 90 minutes after the operation.

Trial Locations

Locations (1)

Erciyes University; 🇹🇷 Kayseri, Melikgazi, Turkey