AnaesthesiaVR OP- tourNCT04579354
Virtual Reality (VR) Tour to Reduce Preoperative Anxiety Before Anaesthesia
A study testing virtual reality tour in people with Anaesthesia and Anxiety, run by RWTH Aachen University at 1 site in Germany.
Trial summary
Anxiety and apprehension are common among patients prior to surgery. This anxiety can lead to additional discomfort, increased pain sensation and increased stress symptoms. Virtual exposure has proven to be successful in exposure therapy for the treatment of the narrowest patients. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Anaesthesia, Anxiety, Postoperative Pain
- What is being tested?
- virtual reality tour
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteGermany
- Study dates
- 7 Sep 2020to 1 Jan 2021
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all patient undergoing anaesthesia without the following exclusion criteria
Who cannot join
- < 18 years
- cancer surgery
- pregnancy
- postoperative setting ICU
- neurosurgery
- Thorax surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Virtual Reality (VR) Tour to Reduce Preoperative Anxiety Before Anaesthesia in an Operating Setting: A Randomized Clinical Trial
Anxiety and apprehension are common among patients prior to surgery. This anxiety can lead to additional discomfort, increased pain sensation and increased stress symptoms. Virtual exposure has proven to be successful in exposure therapy for the treatment of the narrowest patients. Patients are not confronted with the real stimuli or situations that trigger the branches, but with virtual representations of them. Virtual reality (VR) makes it possible to create scenarios that would not be possible in reality because of the organisational, time or financial expenditure involved.The effectiveness of virtual stimulus exposure is well documented, especially in the case of object or situation-related fears in the context of specific phobias. It is therefore obvious that virtual stimulus exposure could also be suitable for minimising operation-associated fears.The research project described is designed to investigate the effect of virtual stimulus exposure on perioperative anxiety. For this purpose, a virtual tour of the operating setting has been created, which enables patients to explore the surroundings in detail by means of VR glasses.
Read the detailed description
Anxiety and apprehension are common among patients prior to surgery. This anxiety can lead to additional discomfort, increased pain sensation and increased stress symptoms. Virtual exposure has proven to be successful in exposure therapy for the treatment of the narrowest patients. Patients are not confronted with the real stimuli or situations that trigger the branches, but with virtual representations of them. Virtual reality (VR) makes it possible to create scenarios that would not be possible in reality because of the organisational, time or financial expenditure involved.The effectiveness of virtual stimulus exposure is well documented, especially in the case of object or situation-related fears in the context of specific phobias. It is therefore obvious that virtual stimulus exposure could also be suitable for minimising operation-associated fears.The research project described is designed to investigate the effect of virtual stimulus exposure on perioperative anxiety. For this purpose, a virtual tour of the operating setting has been created, which enables patients to explore the surroundings in detail by means of VR glasses.
- Conditions
- Anaesthesia, Anxiety, Postoperative Pain
- Being tested
- virtual reality tour
- Keywords
- virtual reality (VR), anxiety preoperative, opearting theater
- Medical subject headings
- Anxiety Disorders, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual reality tourOther
Patients will be guided via VR on their way through the hospital to the operating theater
| Study group | Role | What they receive |
|---|---|---|
| Standardized Anaesthesia briefing | No intervention | standardised anaesthesia information sessions, consisting of a detailed explanation of the anaesthesia procedure by the anaesthetist A specific information sheet is used to explain the procedure and the form of anaesthesia. This corresponds to the current procedure before an operation. |
| Virtual reality (VR) tour | Experimental | standardised anaesthesia information sessions, consisting of a detailed explanation of the anaesthesia procedure by the anaesthetist A specific information sheet is used to explain the procedure and the form of anaesthesia.Subsequently, the patients are shown a virtual tour of the operation using VR glasses. This includes the way through the clinic to the operating theatre: Admission -> inpatient preparation for the operation -> administration of premedication -> way to the operating theater -> OP preparation (holding) -> safe surgery Receives: Other: virtual reality tour |
What is being measured
The primary outcome is the main question the study is designed to answer.
STOA State T1
Questinaire STOA State T1 before anaesthesia
Measured: before anaesthesia
Secondary outcomes (1)
STOA State T2
Questionaire STOA State T2 after anaesthesia
Measured: within 48 hours after anaesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start7 Sep 2020
- Primary completion30 Oct 2020
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnaesthesiaStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04579354
- Sponsor's protocol ID
- EK037/20
- Other IDs
- CTC-A 20-026
- Acronym
- VR OP- tour
- Status last verified
- Mar 2021
- First submitted
- 1 Oct 2020
- Last updated
- 15 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vogt L, Klasen M, Rossaint R, Goeretz U, Ebus P, Sopka S. Virtual Reality Tour to Reduce Perioperative Anxiety in an Operating Setting Before Anesthesia: Randomized Clinical Trial. J Med Internet Res. 2021 Sep 1;23(9):e28018. doi: 10.2196/28018.
PubMed 34252034
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality (VR) Tour to Reduce Preoperative Anxiety Before Anaesthesia in an Operating Setting: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04579354
- Acronym / sponsor ID
- VR OP- tour / EK037/20
- Conditions
- Anaesthesia, Anxiety, Postoperative Pain
- Keywords
- virtual reality (VR), anxiety preoperative, opearting theater
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- 7 Sep 2020 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 8 Oct 2020 (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.
Anxiety and apprehension are common among patients prior to surgery. This anxiety can lead to additional discomfort, increased pain sensation and increased stress symptoms. Virtual exposure has proven to be successful in exposure therapy for the treatment of the narrowest patients. Patients are not confronted with the real stimuli or situations that trigger the branches, but with virtual representations of them. Virtual reality (VR) makes it possible to create scenarios that would not be possible in reality because of the organisational, time or financial expenditure involved.The effectiveness of virtual stimulus exposure is well documented, especially in the case of object or situation-related fears in the context of specific phobias. It is therefore obvious that virtual stimulus exposure could also be suitable for minimising operation-associated fears.The research project described is designed to investigate the effect of virtual stimulus exposure on perioperative anxiety. For this purpose, a virtual tour of the operating setting has been created, which enables patients to explore the surroundings in detail by means of VR glasses.
Detailed description
Anxiety and apprehension are common among patients prior to surgery. This anxiety can lead to additional discomfort, increased pain sensation and increased stress symptoms. Virtual exposure has proven to be successful in exposure therapy for the treatment of the narrowest patients. Patients are not confronted with the real stimuli or situations that trigger the branches, but with virtual representations of them. Virtual reality (VR) makes it possible to create scenarios that would not be possible in reality because of the organisational, time or financial expenditure involved.The effectiveness of virtual stimulus exposure is well documented, especially in the case of object or situation-related fears in the context of specific phobias. It is therefore obvious that virtual stimulus exposure could also be suitable for minimising operation-associated fears.The research project described is designed to investigate the effect of virtual stimulus exposure on perioperative anxiety. For this purpose, a virtual tour of the operating setting has been created, which enables patients to explore the surroundings in detail by means of VR glasses.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standardized Anaesthesia briefing | No intervention | –standardised anaesthesia information sessions, consisting of a detailed explanation of the anaesthesia procedure by the anaesthetist A specific information sheet is used to explain the procedure and the form of anaesthesia. This corresponds to the current procedure before an operation. |
| Virtual reality (VR) tour | Experimental | Other: virtual reality tourstandardised anaesthesia information sessions, consisting of a detailed explanation of the anaesthesia procedure by the anaesthetist A specific information sheet is used to explain the procedure and the form of anaesthesia.Subsequently, the patients are shown a virtual tour of the operation using VR glasses. This includes the way through the clinic to the operating theatre: Admission -> inpatient preparation for the operation -> administration of premedication -> way to the operating theater -> OP preparation (holding) -> safe surgery |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all patient undergoing anaesthesia without the following exclusion criteria
Key exclusion criteria (6 listed)
- < 18 years
- cancer surgery
- pregnancy
- postoperative setting ICU
- neurosurgery
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 reality tourPatients will be guided via VR on their way through the hospital to the operating theater | Other | Virtual reality (VR) tour |
Primary outcome
STOA State T1
Time frame: before anaesthesia
Questinaire STOA State T1 before anaesthesia
1 secondary outcome
STOA State T2
Time frame: within 48 hours after anaesthesia
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 15 Mar 2021.
- Derived from this study: PubMed 34252034Vogt L, Klasen M, Rossaint R, Goeretz U, Ebus P, Sopka S. Virtual Reality Tour to Reduce Perioperative Anxiety in an Operating Setting Before Anesthesia: Randomized Clinical Trial. J Med Internet Res. 2021 Sep 1;23(9):e28018. doi: 10.2196/28018.
- 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 tour in people with Anaesthesia and Anxiety, run by RWTH Aachen University at 1 site in Germany.
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 1 inclusion and 6 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 15 Mar 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 Germany. 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?
STOA State T1 (time frame: before anaesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04579354, which also lists 1 linked publication.
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 15 Mar 2021.