Clinical trial NCT05109767: The Effect of Virtual Reality Glass and Smartphone Game Application on Preoperative Anxiety in Children
Official title: The Effect of Virtual Reality Glass and Smartphone Game Application on Preoperative Anxiety in 7-13 Years Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preoperative Anxiety
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2021-11-05
Enrollment: 60
Sex: ALL
Minimum age (years): 7
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Children's Perioperative Multidimensional Anxiety Scale (CPMAS) Mean Score
timeFrame: 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:
measure: Physiological parameters
timeFrame: One day: One day: Half an hour before and, 45 minutes before the operation and 90 minutes after the operation.
measure: Physiological parameters
timeFrame: One day: Half an hour before and, 45 minutes before the operation and 90 minutes after the operation.
measure: Physiological parameters
timeFrame: One day: One day: Half an hour before and, 45 minutes before the operation and 90 minutes after the operation.
Other outcomes:
measure: Salivary cortisol
timeFrame: One day: Half an hour before the operation
Locations:
city: Kayseri
country: Turkey
facility: Erciyes University
state: Melikgazi
Study officials:
affiliation: TC Erciyes University
name: Nuray Caner, Dr
role: PRINCIPAL_INVESTIGATOR
References: