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

Preoperative Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05109767
• Other study ID #: 2018/103
• Status: Completed
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: March 1, 2020

Study information

• Verified date: October 2021
• Source: TC Erciyes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 1, 2020
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 13 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Preoperative Anxiety

Intervention

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

Locations

Country	Name	City	State
Turkey	Erciyes University	Kayseri	Melikgazi

Sponsors (1)

Lead Sponsor	Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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.
Secondary	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.
Secondary	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.