Anxiety StateNCT06393556
VR for the Reduction of Perioperative Anxiety
A study testing Virtual reality experience in people with Anxiety State, run by Ruhr University of Bochum at 1 site in Australia.
Trial summary
The study, set to take place at Gold Coast University Hospital in Australia, will be conducted as a randomized controlled trial. Patients preparing for gynecological cancer surgery will be recruited and randomly assigned to one of two groups: those who will receive standard care plus a virtual reality (VR)… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anxiety State
- What is being tested?
- Virtual reality experience
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteAustralia
- Study dates
- 10 May 2019to 4 Feb 2022
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Gynecological oncology patients with scheduled surgery
Who cannot join
- Language barrier
- Inability to provide consent
- Having undergone any procedure at the operating theatre in the previous 5 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment and Minimization of Preoperative Fear of the Unknown Using a VR Experience of the Theatre Suite; a Randomized Control Trial
The study, set to take place at Gold Coast University Hospital in Australia, will be conducted as a randomized controlled trial. Patients preparing for gynecological cancer surgery will be recruited and randomly assigned to one of two groups: those who will receive standard care plus a virtual reality (VR) intervention, and those who will receive only standard care. Standard care encompasses the usual pre-operative procedures and support provided by the hospital staff.
We hypothesize that immersing patients in a preparatory virtual environment that shows them what they are to expect during their upcoming hospital stay for surgery, could help reduce their anxiety levels.
Read the detailed description
The study objective is to determine whether exposure to the operating theatre suite via virtual reality (VR) for patients undergoing gynecologic-oncological surgery reduces pre-operative anxiety.
After patients are recruited, their anxiety level is measured by a simple 6-item visual anxiety scale (T0). Patients are then randomized into either receiving care-as-usual (CAU), or CAU combined with a VR experience (~3.5 minutes; with background music and narration) where they are familiarized with the environment they will encounter during their stay for their cancer operation. Anxiety is measured again (T1). Days/weeks later, when patients are back in the hospital for their surgery (T2), anxiety is measured again in the preanesthetic bay, before receiving any anesthetics. Personnel collecting the anxiety scale at T2 will be unaware whether a patient had received the VR intervention or not.
Randomization will be performed by a person unrelated to the study by using a computerized randomization tool to generate an allocation list and inserting paper slips with the group allocation into consecutively numbered, opaque envelopes which are opened, in order, at the time of randomization.
Using a two-sided Wilcoxon-Mann-Whitney test and targeting a power of 80% at a significance level α of 0.05, abd assuming a clinically relevant difference in the anxiety scale of at least one "face" (i.e. at least 1 point on the 6-item scale) between the two groups and a within-group standard deviation of 1.6 (effect size: 0.625), sample size was determined as 34 patients per group for a 1:1 group allocation. Assuming a drop out/lost-to-follow up rate of up to 15%, 80 patients (40 per group) are to be recruited.
Descriptive statistic analysis will be performed. Within-group and between-group assessements will be done using Wilcoxon signed rank test and the Mann-Whitney rank sum test, respectively.
- Conditions
- Anxiety State
- Being tested
- Virtual reality experience
- Keywords
- anxiety, virtual reality, gynecologic-oncological surgery
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality experienceOther
An immersive VR experience, delivered using a VR head-mounted display, of the real-world environment at the hospital, featuring the pre-operative admission suite, pre-anesthetic bay, operating theatre, postoperative recovery room, and medical staff.
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality | Experimental | Care-as-usual + virtual reality intervention during a pre-operative visit Receives: Other: Virtual reality experience |
| Control | No intervention | Care-as-usual during a pre-operative visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
Anxiety level measured by a 6-item visual scale (1 .. least anxiety, 6 ... highest anxiety)
Measured: T0 (before randomization), T1 (same day as T0, but after care as usual +/- VR; usually inside 1 hour), T2 (days/weeks later, before surgical procedure - exact gap is unknown; expected: >3 days, median around 4-7 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start10 May 2019
- Primary completion4 Feb 2022
- Study completion4 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anxiety StateStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 randomization
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruhr University of Bochum
- Sponsor type
- University, hospital or other
- Collaborators
- Gold Coast Hospital and Health Service
- Responsible party
- Principal investigator, Günther Rezniczek, Ruhr University of Bochum
- Investigators
- Bernd C Schmid, MD, Principal investigator, Gold Coast University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06393556
- Sponsor's protocol ID
- VRPERIOP1
- Status last verified
- May 2024
- First submitted
- 26 Apr 2024
- Last updated
- 31 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be shared upon reasonable request for purposes that have been approved by the respective Institutional Review Board
Publications
Cao X, Yumul R, Elvir Lazo OL, Friedman J, Durra O, Zhang X, White PF. A novel visual facial anxiety scale for assessing preoperative anxiety. PLoS One. 2017 Feb 14;12(2):e0171233. doi: 10.1371/journal.pone.0171233. eCollection 2017.
PubMed 28196099Schmid BC, Marsland D, Jacobs E, Rezniczek GA. A Preparatory Virtual Reality Experience Reduces Anxiety before Surgery in Gynecologic Oncology Patients: A Randomized Controlled Trial. Cancers (Basel). 2024 May 17;16(10):1913. doi: 10.3390/cancers16101913.
PubMed 38791991
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment and Minimization of Preoperative Fear of the Unknown Using a VR Experience of the Theatre Suite; a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06393556
- Acronym / sponsor ID
- VRPERIOP1
- Conditions
- Anxiety State
- Keywords
- anxiety, virtual reality, gynecologic-oncological surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Collaborators
- Gold Coast Hospital and Health Service
- Study start
- 10 May 2019 (actual)
- Primary completion
- 4 Feb 2022 (actual)
- Study completion
- 4 Feb 2022 (actual)
- First posted
- 1 May 2024 (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.
The study, set to take place at Gold Coast University Hospital in Australia, will be conducted as a randomized controlled trial. Patients preparing for gynecological cancer surgery will be recruited and randomly assigned to one of two groups: those who will receive standard care plus a virtual reality (VR) intervention, and those who will receive only standard care. Standard care encompasses the usual pre-operative procedures and support provided by the hospital staff.
We hypothesize that immersing patients in a preparatory virtual environment that shows them what they are to expect during their upcoming hospital stay for surgery, could help reduce their anxiety levels.
Detailed description
The study objective is to determine whether exposure to the operating theatre suite via virtual reality (VR) for patients undergoing gynecologic-oncological surgery reduces pre-operative anxiety.
After patients are recruited, their anxiety level is measured by a simple 6-item visual anxiety scale (T0). Patients are then randomized into either receiving care-as-usual (CAU), or CAU combined with a VR experience (~3.5 minutes; with background music and narration) where they are familiarized with the environment they will encounter during their stay for their cancer operation. Anxiety is measured again (T1). Days/weeks later, when patients are back in the hospital for their surgery (T2), anxiety is measured again in the preanesthetic bay, before receiving any anesthetics. Personnel collecting the anxiety scale at T2 will be unaware whether a patient had received the VR intervention or not.
Randomization will be performed by a person unrelated to the study by using a computerized randomization tool to generate an allocation list and inserting paper slips with the group allocation into consecutively numbered, opaque envelopes which are opened, in order, at the time of randomization.
Using a two-sided Wilcoxon-Mann-Whitney test and targeting a power of 80% at a significance level α of 0.05, abd assuming a clinically relevant difference in the anxiety scale of at least one "face" (i.e. at least 1 point on the 6-item scale) between the two groups and a within-group standard deviation of 1.6 (effect size: 0.625), sample size was determined as 34 patients per group for a 1:1 group allocation. Assuming a drop out/lost-to-follow up rate of up to 15%, 80 patients (40 per group) are to be recruited.
Descriptive statistic analysis will be performed. Within-group and between-group assessements will be done using Wilcoxon signed rank test and the Mann-Whitney rank sum test, respectively.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- 1:1 randomization
| Arm | Type | Receives |
|---|---|---|
| Virtual reality | Experimental | Other: Virtual reality experienceCare-as-usual + virtual reality intervention during a pre-operative visit |
| Control | No intervention | –Care-as-usual during a pre-operative visit |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Gynecological oncology patients with scheduled surgery
Key exclusion criteria (3 listed)
- Language barrier
- Inability to provide consent
- Having undergone any procedure at the operating theatre in the previous 5 years
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 experienceAn immersive VR experience, delivered using a VR head-mounted display, of the real-world environment at the hospital, featuring the pre-operative admission suite, pre-anesthetic bay, operating theatre, postoperative recovery room, and medical staff. | Other | Virtual reality |
Primary outcome
Anxiety
Time frame: T0 (before randomization), T1 (same day as T0, but after care as usual +/- VR; usually inside 1 hour), T2 (days/weeks later, before surgical procedure - exact gap is unknown; expected: >3 days, median around 4-7 weeks)
Anxiety level measured by a 6-item visual scale (1 .. least anxiety, 6 ... highest anxiety)
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 31 May 2024.
- Background: PubMed 28196099Cao X, Yumul R, Elvir Lazo OL, Friedman J, Durra O, Zhang X, White PF. A novel visual facial anxiety scale for assessing preoperative anxiety. PLoS One. 2017 Feb 14;12(2):e0171233. doi: 10.1371/journal.pone.0171233. eCollection 2017.
- Results publication: PubMed 38791991Schmid BC, Marsland D, Jacobs E, Rezniczek GA. A Preparatory Virtual Reality Experience Reduces Anxiety before Surgery in Gynecologic Oncology Patients: A Randomized Controlled Trial. Cancers (Basel). 2024 May 17;16(10):1913. doi: 10.3390/cancers16101913.
- Individual participant dataSharing planned: Yes. De-identified data will be shared upon reasonable request for purposes that have been approved by the respective Institutional Review Board
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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.
Bernd C Schmid, MD principal investigator
Gold Coast University Hospital
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 experience in people with Anxiety State, run by Ruhr University of Bochum at 1 site in Australia.
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 3 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 31 May 2024. 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 Australia. 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?
Anxiety (time frame: T0 (before randomization), T1 (same day as T0, but after care as usual +/- VR; usually inside 1 hour), T2 (days/weeks later, before surgical procedure - exact gap is unknown; expected: >3 days, median around 4-7 weeks)). 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 NCT06393556, which also lists 2 linked publications.
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 31 May 2024.