Preoperative AnxietyNCT05109767
The Effect of Virtual Reality Glass and Smartphone Game Application on Preoperative Anxiety in Children
A study testing Virtual reality and Smartphone in people with Preoperative Anxiety, run by TC Erciyes University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 7 to 13 years
- Conditions the study is for
- Preoperative Anxiety
- What is being tested?
- Virtual reality and Smartphone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2019to 1 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Virtual Reality Glass and Smartphone Game Application on Preoperative Anxiety in 7-13 Years 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.
Read the 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.
- Conditions
- Preoperative Anxiety
- Being tested
- Virtual reality, Smartphone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual realityDevice
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.
SmartphoneDevice
The Smartphone game application reduces anxiety by distracting attention. Smartphone game was played to intervention group for 15 minutes before surgery.
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality glass game application | Experimental | Not described Receives: Device: Virtual reality |
| Smartphone game application | Active comparator | Not described Receives: Device: Smartphone |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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 (3)
Physiological parameters
Heart Rate, Change= Half an hour before and, 45 minutes before the operation and 90 minutes after the operation.
Measured: One day: One day: Half an hour before and, 45 minutes before the operation and 90 minutes after the operation.
Physiological parameters
Oxygen saturation, Change= Half an hour before and, 45 minutes before the operation and 90 minutes after the operation.
Measured: One day: Half an hour before and, 45 minutes before the operation and 90 minutes after the operation.
Physiological parameters
Blood pressure, Change= Half an hour before and, 45 minutes before the operation and 90 minutes after the operation.
Measured: One day: One day: Half an hour before and, 45 minutes before the operation and 90 minutes after the operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start1 Jul 2019
- Primary completion1 Jul 2019
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative AnxietyStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nuray Caner, TC Erciyes University
- Investigators
- Nuray Caner, Dr, Principal investigator, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05109767
- Sponsor's protocol ID
- 2018/103
- Status last verified
- Oct 2021
- First submitted
- 8 Oct 2021
- Last updated
- 5 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality Glass and Smartphone Game Application on Preoperative Anxiety in 7-13 Years Children
- ClinicalTrials.gov ID
- NCT05109767
- Acronym / sponsor ID
- 2018/103
- Conditions
- Preoperative Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 5 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Virtual reality glass game application | Experimental | Device: Virtual reality |
| Smartphone game application | Active comparator | Device: Smartphone |
| Control group | No intervention | – |
Who may qualify
- Ages
- 7 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual realityThe 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. | Device | Virtual reality glass game application |
| SmartphoneThe Smartphone game application reduces anxiety by distracting attention. Smartphone game was played to intervention group for 15 minutes before surgery. | Device | Smartphone game application |
Primary outcome
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).
3 secondary outcomes
Physiological parameters
Time frame: One day: One day: Half an hour before and, 45 minutes before the operation and 90 minutes after the operation.
Physiological parameters
Time frame: One day: Half an hour before and, 45 minutes before the operation and 90 minutes after the operation.
Physiological parameters
Time frame: One day: One day: Half an hour before and, 45 minutes before the operation and 90 minutes after the operation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nuray Caner, Dr principal investigator
TC Erciyes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality and Smartphone in people with Preoperative Anxiety, run by TC Erciyes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2021; AzTrials last refreshed its copy on 7 Nov 2026.