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

NCT ID: NCT05109767

Last Updated: 2021-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2020-03-01

Brief Summary

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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

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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.

Conditions

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Preoperative Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Virtual reality glass game application

Group Type EXPERIMENTAL

Virtual reality

Intervention Type 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.

Smartphone game application

Group Type ACTIVE_COMPARATOR

Smartphone

Intervention Type DEVICE

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

Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Smartphone

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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TC Erciyes University

OTHER

Sponsor Role lead

Responsible Party

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Nuray Caner

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nuray Caner, Dr

Role: PRINCIPAL_INVESTIGATOR

TC Erciyes University

Locations

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Erciyes University

Kayseri, Melikgazi, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2018/103

Identifier Type: -

Identifier Source: org_study_id