AnxietyNCT04824690
The Effect Of Immersive Virtual Reality Application On Anxiety, Pain And Family Satisfaction In The Perioperative Process Of Children
A study testing Virtual reality in people with Anxiety and Pain, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
An immersive virtual reality (VR) tour of the operating theater before surgery could reduce preoperative anxiety. The aims of this study were to analyze whether a preoperative virtual reality tour shows a reduction in anxiety in children and an increase in parental satisfaction. Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Anxiety, Pain, Satisfaction
- What is being tested?
- Virtual reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2019to 31 Aug 2019
- 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 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children 4-10 years old
- ASA grade I or II
- General anesthesia
- Elective surgery
Who cannot join
- Children who have had previous surgery history
- Local anesthesia or emergency surgeries
- Premature or congenital disease history
- Having visual and hearing impairment
- Mental and developmental retardation
- Having a history of epilepsy and seizures
- Patients taking psychoactive drugs
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bolu Abant İzzet Baysal University
Bolu, 14030
About this study
An immersive virtual reality (VR) tour of the operating theater before surgery could reduce preoperative anxiety. The aims of this study were to analyze whether a preoperative virtual reality tour shows a reduction in anxiety in children and an increase in parental satisfaction.
Read the detailed description
Children who will undergo surgery for the first time and their families were randomly allocated into the control or VR group. The control group received conventional education regarding the perioperative process of surgery. The VR group watched a 1.5-minute VR video showing the operating theater and explaining the perioperative process. The main finding was preoperative anxiety evaluated using the Children's State Anxiety (CSA) before surgery. Secondary findings included children's postoperative pain ratings using Wong-Baker Faces Pain Rating Scale and parental satisfaction scores using PedsQL Health Care Satisfaction Scale
- Conditions
- Anxiety, Pain, Satisfaction
- Being tested
- Virtual reality
- Keywords
- Anxiety, Pain, Parental Satisfaction, Virtual Reality
- Medical subject headings
- Anxiety Disorders, Pain, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual realityDevice
Immersive virtual reality tour of the operating theatre before surgery and distraction methods both using VR headset
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Group | Experimental | The virtual reality group watched a 1.5-minute VR video showing the operating theater and explaining the perioperative process. After the surgery, this group watched cartoons during the first standard nursing procedures after the effect of the anesthesia wore off. Receives: Device: Virtual reality |
| Control Group | No intervention | The control group received conventional care and education regarding the perioperative process of surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative anxiety assessed by the Children's State Anxiety (CAM-S)
The CAM-S scale is drawn to resemble a thermometer with a bulb at the bottom and horizontal lines at intervals going up to the top. Children are instructed to "Pretend that all of your worried or nervous feelings are in the bulb or bottom part of the thermometer. If you are a little bit worried or nervous, the feelings might come up in the thermometer just a little bit. If you are very, very worried or nervous, the feelings might go all the way to the top. Put a line on the thermometer showing how much worry or nervousness you feel. Min score : 0 \& Max score : 10
Measured: This is measured right before the child goes into operating theatre / separating from his/her parents.
Secondary outcomes (3)
Postoperative Pain assessed by the Wong-Baker Faces Pain Rating Scale
The scale is used around the world with people ages 3 and older. Min score : 0 \& Max score : 5
Measured: This is measured immediately after the surgery.
Parental Satisfaction assessed by PedsQL Health Care Satisfaction Scale
Parents answered the following scale questions by indicating how satisfied they are with the services provided to them and their children. Min score : 0 \& Max score : 100
Measured: This is measured immediately after the intervention.
Postoperative anxiety assessed by the Children's State Anxiety (CAM-S)
The CAM-S scale is drawn to resemble a thermometer with a bulb at the bottom and horizontal lines at intervals going up to the top. Children are instructed to "Pretend that all of your worried or nervous feelings are in the bulb or bottom part of the thermometer. If you are a little bit worried or nervous, the feelings might come up in the thermometer just a little bit. If you are very, very worried or nervous, the feelings might go all the way to the top. Put a line on the thermometer showing how much worry or nervousness you feel. Min score : 0 \& Max score : 10
Measured: This is measured immediately after the surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start1 Mar 2019
- Primary completion31 Aug 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aykut Turgut, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04824690
- Sponsor's protocol ID
- 2019_78
- Status last verified
- Mar 2021
- First submitted
- 24 Mar 2021
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Immersive Virtual Reality Application On Anxiety, Pain And Family Satisfaction In The Perioperative Process Of Children
- ClinicalTrials.gov ID
- NCT04824690
- Acronym / sponsor ID
- 2019_78
- Conditions
- Anxiety, Pain, Satisfaction
- Keywords
- Anxiety, Pain, Parental Satisfaction, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 1 Apr 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.
An immersive virtual reality (VR) tour of the operating theater before surgery could reduce preoperative anxiety. The aims of this study were to analyze whether a preoperative virtual reality tour shows a reduction in anxiety in children and an increase in parental satisfaction.
Detailed description
Children who will undergo surgery for the first time and their families were randomly allocated into the control or VR group. The control group received conventional education regarding the perioperative process of surgery. The VR group watched a 1.5-minute VR video showing the operating theater and explaining the perioperative process. The main finding was preoperative anxiety evaluated using the Children's State Anxiety (CSA) before surgery. Secondary findings included children's postoperative pain ratings using Wong-Baker Faces Pain Rating Scale and parental satisfaction scores using PedsQL Health Care Satisfaction Scale
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Group | Experimental | Device: Virtual realityThe virtual reality group watched a 1.5-minute VR video showing the operating theater and explaining the perioperative process. After the surgery, this group watched cartoons during the first standard nursing procedures after the effect of the anesthesia wore off. |
| Control Group | No intervention | –The control group received conventional care and education regarding the perioperative process of surgery. |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children 4-10 years old
- ASA grade I or II
- General anesthesia
- Elective surgery
Key exclusion criteria (7 listed)
- Children who have had previous surgery history
- Local anesthesia or emergency surgeries
- Premature or congenital disease history
- Having visual and hearing impairment
- Mental and developmental retardation
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 realityImmersive virtual reality tour of the operating theatre before surgery and distraction methods both using VR headset | Device | Virtual Reality Group |
Primary outcome
Preoperative anxiety assessed by the Children's State Anxiety (CAM-S)
Time frame: This is measured right before the child goes into operating theatre / separating from his/her parents.
The CAM-S scale is drawn to resemble a thermometer with a bulb at the bottom and horizontal lines at intervals going up to the top. Children are instructed to "Pretend that all of your worried or nervous feelings are in the bulb or bottom part of the thermometer. If you are a little bit worried or nervous, the feelings might come up in the thermometer just a little bit. If you are very, very worried or nervous, the feelings might go all the way to the top. Put a line on the thermometer showing how much worry or nervousness you feel. Min score : 0 \& Max score : 10
3 secondary outcomes
Postoperative Pain assessed by the Wong-Baker Faces Pain Rating Scale
Time frame: This is measured immediately after the surgery.
Parental Satisfaction assessed by PedsQL Health Care Satisfaction Scale
Time frame: This is measured immediately after the intervention.
Postoperative anxiety assessed by the Children's State Anxiety (CAM-S)
Time frame: This is measured immediately after the surgery.
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 1 Apr 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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Anxiety and Pain, run by Abant Izzet Baysal 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 4 inclusion and 7 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 1 Apr 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?
Preoperative anxiety assessed by the Children's State Anxiety (CAM-S) (time frame: This is measured right before the child goes into operating theatre / separating from his/her parents.). 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 1 Apr 2021.