PreoperativeRVAQUANCT03905915
Virtual Reality (VR) to Reduce Preoperative Anxiety.
A study testing Virtual reality (VR) session with AQUA module in people with Preoperative, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
Most patients awaiting surgery show significant anxiety score which can be influenced by the fear of anesthesia or surgery but also by the context of care. These anxious patients will have more postoperative complications and can also develop chronic pain. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Preoperative
- What is being tested?
- Virtual reality (VR) session with AQUA module
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- 26 Feb 2019to 31 Dec 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients undergoing scheduled orthopedic surgery with loco-regional anesthesia at Saint-Luc Hospital.
- Patients not following long-term psychotherapeutic treatment
- Patients not taking psychotropic medication
- free, informed and written consent signed by the investigator and the patient before the procedure.
Who cannot join
- patient not speaking French
- Patients with long-term psychotherapeutic treatment
- Patients taking psychotropic drugs
- patient blind and deaf
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Cliniques universitaires Saint-luc
Brussels, 1200
Fabienne Roelants, MD, +3227641821, fabienne.roelants@uclouvain.be
Nassim Touil, MD, +3227641821, nassim.touil@uclouvain.be
About this study
Official title: The Impact of Induced Hypnosis by Virtual Reality AQUA Module on Preoperative Anxiety.
Most patients awaiting surgery show significant anxiety score which can be influenced by the fear of anesthesia or surgery but also by the context of care. These anxious patients will have more postoperative complications and can also develop chronic pain. The Virtual reality AQUA module induces hypnosis and is specially designed to reduce anxiety. The purpose of the study is to examine the effect of a virtual reality session on preoperative anxiety.
- Conditions
- Preoperative
- Being tested
- Virtual reality (VR) session with AQUA module
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality (VR) session with AQUA moduleDevice
A device with virtual reality is given to the patients with a film of 15 minutes
| Study group | Role | What they receive |
|---|---|---|
| Preoperative virtual reality session | Other | Amsterdam Anxiety score recorded before VR session is followed by a 15 min VR session and finally Amsterdam Anxiety score is recorded after VR session Receives: Device: Virtual reality (VR) session with AQUA module |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Amsterdam preoperative anxiety and information score (APAIS) after VR session
The Amsterdam preoperative anxiety and information (APAIS) scale is a 6-items questionnaire. Each item is scored from 1(not at all) to 5(extremely). 4 items assess anxiety (patient with a score >or = to 11 is considered very anxious), 2 items assess the desire for information (patient with a score > 8 is considered very anxious because there is a corelation between need for informa tion and anxiety). The score ranges from 6 (no anxious) to 30 (highly anxious).
Measured: 5 minutes after virtual reality session
Secondary outcomes (2)
Evaluation du Vécu de l'ANesthésie - LocoRégionale) EVAN-LR satisfaction score
Evaluation du Vécu de l'Anesthésie LocoRégionale (EVAN-LR) is a tool assessing patient satisfaction within the perioperative period surrounding regional anesthesia. The EVAN-LR comprises 19 items, structured in a global index and five dimensions: Attention, Information, Discomfort, Waiting, and Pain. Each item is scored from 1(not at all) to 5(extremely). The score ranges from 18(no satisfied) to 95 (highly satisfied).
Measured: 2 hours after VR session (in the recovery room, after surgery)
Change of Visual Analog Score (VAS) anxiety score after VR session
score between 0 ( no anxious) and 10 (highly anxious)
Measured: 5 minutes after the virtual reality session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2019
- Study start26 Feb 2019
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PreoperativeStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roelants, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Investigators
- Roelants Fabienne, MD, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03905915
- Sponsor's protocol ID
- 2016/20JUL/345
- Acronym
- RVAQUA
- Status last verified
- Apr 2019
- First submitted
- 26 Mar 2019
- Last updated
- 8 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ruhaiyem ME, Alshehri AA, Saade M, Shoabi TA, Zahoor H, Tawfeeq NA. Fear of going under general anesthesia: A cross-sectional study. Saudi J Anaesth. 2016 Jul-Sep;10(3):317-21. doi: 10.4103/1658-354X.179094.
PubMed 27375388Scavee V, Dehullu JP, Scavee JP, Michel I. Impact of Anxiety in Ambulatory Superficial Venous Surgery : A Prospective Study Using the HADS-A Scale. Acta Chir Belg. 2015 Jan-Feb;115:42-8.
PubMed 26021790Ganry L, Hersant B, Sidahmed-Mezi M, Dhonneur G, Meningaud JP. Using virtual reality to control preoperative anxiety in ambulatory surgery patients: A pilot study in maxillofacial and plastic surgery. J Stomatol Oral Maxillofac Surg. 2018 Sep;119(4):257-261. doi: 10.1016/j.jormas.2017.12.010. Epub 2018 Jan 6.
PubMed 29317347Maurice-Szamburski A, Bruder N, Loundou A, Capdevila X, Auquier P. Development and validation of a perioperative satisfaction questionnaire in regional anesthesia. Anesthesiology. 2013 Jan;118(1):78-87. doi: 10.1097/ALN.0b013e31827469f2.
PubMed 23221859Maurice-Szamburski A, Loundou A, Capdevila X, Bruder N, Auquier P. Validation of the French version of the Amsterdam preoperative anxiety and information scale (APAIS). Health Qual Life Outcomes. 2013 Oct 7;11:166. doi: 10.1186/1477-7525-11-166.
PubMed 24099176
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Induced Hypnosis by Virtual Reality AQUA Module on Preoperative Anxiety.
- ClinicalTrials.gov ID
- NCT03905915
- Acronym / sponsor ID
- RVAQUA / 2016/20JUL/345
- Conditions
- Preoperative
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 26 Feb 2019 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 8 Apr 2019 (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.
Most patients awaiting surgery show significant anxiety score which can be influenced by the fear of anesthesia or surgery but also by the context of care. These anxious patients will have more postoperative complications and can also develop chronic pain. The Virtual reality AQUA module induces hypnosis and is specially designed to reduce anxiety. The purpose of the study is to examine the effect of a virtual reality session on preoperative anxiety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preoperative virtual reality session | Other | Device: Virtual reality (VR) session with AQUA moduleAmsterdam Anxiety score recorded before VR session is followed by a 15 min VR session and finally Amsterdam Anxiety score is recorded after VR session |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients undergoing scheduled orthopedic surgery with loco-regional anesthesia at Saint-Luc Hospital.
- Patients not following long-term psychotherapeutic treatment
- Patients not taking psychotropic medication
- free, informed and written consent signed by the investigator and the patient before the procedure.
Key exclusion criteria (4 listed)
- patient not speaking French
- Patients with long-term psychotherapeutic treatment
- Patients taking psychotropic drugs
- patient blind and deaf
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 (VR) session with AQUA moduleA device with virtual reality is given to the patients with a film of 15 minutes | Device | Preoperative virtual reality session |
Primary outcome
Change of Amsterdam preoperative anxiety and information score (APAIS) after VR session
Time frame: 5 minutes after virtual reality session
The Amsterdam preoperative anxiety and information (APAIS) scale is a 6-items questionnaire. Each item is scored from 1(not at all) to 5(extremely). 4 items assess anxiety (patient with a score >or = to 11 is considered very anxious), 2 items assess the desire for information (patient with a score > 8 is considered very anxious because there is a corelation between need for informa tion and anxiety). The score ranges from 6 (no anxious) to 30 (highly anxious).
2 secondary outcomes
Evaluation du Vécu de l'ANesthésie - LocoRégionale) EVAN-LR satisfaction score
Time frame: 2 hours after VR session (in the recovery room, after surgery)
Change of Visual Analog Score (VAS) anxiety score after VR session
Time frame: 5 minutes after the virtual reality session
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2019.
- Results publication: PubMed 27375388Ruhaiyem ME, Alshehri AA, Saade M, Shoabi TA, Zahoor H, Tawfeeq NA. Fear of going under general anesthesia: A cross-sectional study. Saudi J Anaesth. 2016 Jul-Sep;10(3):317-21. doi: 10.4103/1658-354X.179094.
- Results publication: PubMed 26021790Scavee V, Dehullu JP, Scavee JP, Michel I. Impact of Anxiety in Ambulatory Superficial Venous Surgery : A Prospective Study Using the HADS-A Scale. Acta Chir Belg. 2015 Jan-Feb;115:42-8.
- Results publication: PubMed 29317347Ganry L, Hersant B, Sidahmed-Mezi M, Dhonneur G, Meningaud JP. Using virtual reality to control preoperative anxiety in ambulatory surgery patients: A pilot study in maxillofacial and plastic surgery. J Stomatol Oral Maxillofac Surg. 2018 Sep;119(4):257-261. doi: 10.1016/j.jormas.2017.12.010. Epub 2018 Jan 6.
- Results publication: PubMed 23221859Maurice-Szamburski A, Bruder N, Loundou A, Capdevila X, Auquier P. Development and validation of a perioperative satisfaction questionnaire in regional anesthesia. Anesthesiology. 2013 Jan;118(1):78-87. doi: 10.1097/ALN.0b013e31827469f2.
- Results publication: PubMed 24099176Maurice-Szamburski A, Loundou A, Capdevila X, Bruder N, Auquier P. Validation of the French version of the Amsterdam preoperative anxiety and information scale (APAIS). Health Qual Life Outcomes. 2013 Oct 7;11:166. doi: 10.1186/1477-7525-11-166.
- 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.
Roelants Fabienne, MD principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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 (VR) session with AQUA module in people with Preoperative, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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 4 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: status not confirmed, as of the sponsor's last update on 8 Apr 2019. 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fabienne Roelants, MD (+32 2 764 18 21, fabienne.roelants@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Amsterdam preoperative anxiety and information score (APAIS) after VR session (time frame: 5 minutes after virtual reality session). 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 NCT03905915, which also lists 5 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 8 Apr 2019.