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Completed

NCT Number: NCT05109767

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

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Key information

Age range

7 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erciyes University

Kayseri, Melikgazi, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

smartphone

Device

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

Primary outcomes

  1. Children's Perioperative Multidimensional Anxiety Scale (CPMAS) Mean Score

    Time frame: 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 outcomes

  1. Physiological parameters

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

    Heart Rate, Change= Half an hour before and, 45 minutes before the operation and 90 minutes after the operation.

  2. Physiological parameters

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

    Oxygen saturation, Change= Half an hour before and, 45 minutes before the operation and 90 minutes after the operation.

  3. Physiological parameters

    Time frame: 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.

Other outcomes

  1. Salivary cortisol

    Time frame: One day: Half an hour before the operation

    Serum biochemical parameters.The high level of salivary cortisol is interpreted as an increase in cortisol secretion.

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Nov 5, 2021
Registry last updated
Nov 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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