Anxiety PostoperativeNCT04561596
Virtually Augmented Self Hypnosis in Peripheral Vascular Interventions
A study testing OnComfort autohypnosis and Treatment as usual, without the OnComfort autohypnosis system in people with Anxiety Postoperative and Pain, Postoperative, run by Salah D. Qanadli, MD, PhD at 1 site in Switzerland.
Trial summary
The aim of our study is to compare patients anxiety and pain during percutaneous vascular interventions with and without virtual reality autohypnosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety Postoperative, Pain, Postoperative, Vascular Access Site Pain
- What is being tested?
- OnComfort autohypnosis and Treatment as usual, without the OnComfort autohypnosis system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- 23 Sep 2020to 31 Aug 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent as documented by signature
- > 18 years
- Any indication for a percutaneous vascular interventional with a single vascular access (angiography, phlebography, arterial intervention, venous intervention) planned to be done under local anesthesia
Who cannot join
- No French language comprehension, deaf or visually impaired patient
- Inability to sign informed consent
- Need of sedative medication
- History of motion sickness
- History of psychiatric disease such as paranoia, schizophrenia, deep water phobia and dementia
- Patient does not tolerate the virtual reality mask during the pre operative visit at Day 1
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Virtually Augmented Self Hypnosis: Randomized Controlled Trial in Peripheral Vascular Interventions
The aim of our study is to compare patients anxiety and pain during percutaneous vascular interventions with and without virtual reality autohypnosis.
Read the detailed description
The participants in the control group will be treated under local anesthesia, following the usual care protocols.
The participants in the experimental group will be treated under the same conditions, except that they will experience virtual reality autohypnosis during the intervention.
- Being tested
- OnComfort autohypnosis, Treatment as usual, without the OnComfort autohypnosis system
- Keywords
- Anxiety, Pain, Virtual reality, Virtual reality autohypnosis, Hypnosis, Non-pharmacological approaches
- Medical subject headings
- Pain, Postoperative, Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OnComfort autohypnosisDevice
Participant arrive in our day care clinic and is prepared as any other patient in interventional radiology. The investigator will collect the signed informed consent form and proceed to randomization.
The participant will then fill the pre and post-operative anxiety and pain questionnaire.
The percutaneous vascular procedure will be performed as usual except for the virtual reality mask and autohypnosis software that will run during the whole intervention.
Pain and anxiolytic medication are provided if needed during the intervention. Immediately after the intervention, the participant will fill the post-operative anxiety and pain questionnaire. The participant will be instructed to report anxiety and pain felt during the intervention.
A clinical visit at 3 month is conducted as part of the standard clinical protocol. The participant will fill a 3rd questionnaire about the remembered anxiety and pain during the intervention.
Treatment as usual, without the OnComfort autohypnosis systemOther
The Participant arrive in our day care clinic and is prepared as any other patient in interventional radiology. The investigator will collect the signed informed consent form and proceed to randomization.
The participant will then fill the pre and post-operative anxiety and pain questionnaire.
The percutaneous vascular procedure will be performed as usual. Pain and anxiolytic medication are provided if needed during the intervention. Immediately after the intervention, the participant will fill the post-operative anxiety and pain questionnaire. The participant will be instructed to report anxiety and pain felt during the intervention.
A clinical visit at 3 month is conducted as part of the standard clinical protocol. The participant will fill a 3rd questionnaire about the remembered anxiety and pain during the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Autohypnosis | Experimental | Use of virtual reality with head mounted display Receives: Device: OnComfort autohypnosis |
| Control | Other | Treatment as usual Receives: Other: Treatment as usual, without the OnComfort autohypnosis system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Per procedural anxiety.
Per procedural anxiety, measured by the Spielberger Anxiety State Inventory in French (Gauthier and Bouchard, 1993).
The Spielberger Anxiety State Inventory is a self questionnaire of 20 items, each item scores from 1 to 4. The result of the test is the sum of the 20 items, therefore the result ranges from 20 to 80. A high score is related to a high level of anxiety at the moment of the test.
Measured: Day 1 (Immediately after the peripheral vascular intervention)
Secondary outcomes (5)
Per procedural pain.
Per procedural pain, measured by the visual analog pain scale. The visual analog pain scale rates pain from 0 to 10, 0 being the least pain imaginable and 10 the maximal pain imaginable.
Measured: Day 1 (Immediately after the peripheral vascular intervention)
Remembered per procedural anxiety.
Remembered per procedural anxiety measured by the Spielberg Anxiety State Inventory in French (Gauthier and Bouchard, 1993).
The Spielberger Anxiety State Inventory is a self questionnaire of 20 items, each item scores from 1 to 4. The result of the test is the sum of the 20 items, therefore the result ranges from 20 to 80. A high score is related to a high level of anxiety at the moment of the test.
Measured: 3 months
Remembered per procedural pain.
Remembered per procedural pain will be measured by the visual analog pain scale.
The visual analog pain scale rates pain from 0 to 10, 0 being the least pain imaginable and 10 the maximal pain imaginable.
Measured: 3 months
Adverse events
Device deficiencies
Measured: Day 1
Serious adverse events
Amputation, mesenteric or renal ischemia, and death
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start23 Sep 2020
- Primary completion5 Oct 2020
- Study completion31 Aug 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 PostoperativeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Salah D. Qanadli, MD, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Salah D. Qanadli, MD, PhD, University of Lausanne
- Investigators
- Salah Dine Qanadli, Prof. MD PhD, Study director, Unil, CHUV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04561596
- Sponsor's protocol ID
- 2020-00728
- Status last verified
- Sep 2022
- First submitted
- 9 Sep 2020
- Last updated
- 30 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gullo G, Rotzinger DC, Colin A, Frossard P, Gudmundsson L, Jouannic AM, Qanadli SD. Virtually Augmented Self-Hypnosis in Peripheral Vascular Intervention: A Randomized Controlled Trial. Cardiovasc Intervent Radiol. 2023 Jun;46(6):786-793. doi: 10.1007/s00270-023-03394-1. Epub 2023 Mar 21.
PubMed 36944851Qanadli SD, Gudmundsson L, Gullo G, Ponti A, Saltiel S, Jouannic AM, Faouzi M, Rotzinger DC. Virtually Augmented Self-Hypnosis applied to endovascular interventions (VA-HYPO): Randomized Controlled Trial Protocol. PLoS One. 2022 Feb 23;17(2):e0263002. doi: 10.1371/journal.pone.0263002. eCollection 2022.
PubMed 35196310
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtually Augmented Self Hypnosis: Randomized Controlled Trial in Peripheral Vascular Interventions
- ClinicalTrials.gov ID
- NCT04561596
- Acronym / sponsor ID
- 2020-00728
- Keywords
- Anxiety, Pain, Virtual reality, Virtual reality autohypnosis, Hypnosis, Non-pharmacological approaches
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Salah D. Qanadli, MD, PhDUniversity, hospital or other
- Study start
- 23 Sep 2020 (actual)
- Primary completion
- 5 Oct 2020 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 23 Sep 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.
The aim of our study is to compare patients anxiety and pain during percutaneous vascular interventions with and without virtual reality autohypnosis.
Detailed description
The participants in the control group will be treated under local anesthesia, following the usual care protocols.
The participants in the experimental group will be treated under the same conditions, except that they will experience virtual reality autohypnosis during the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autohypnosis | Experimental | Device: OnComfort autohypnosisUse of virtual reality with head mounted display |
| Control | Other | Other: Treatment as usual, without the OnComfort autohypnosis systemTreatment as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Informed consent as documented by signature
- > 18 years
- Any indication for a percutaneous vascular interventional with a single vascular access (angiography, phlebography, arterial intervention, venous intervention) planned to be done under local anesthesia
Key exclusion criteria (6 listed)
- No French language comprehension, deaf or visually impaired patient
- Inability to sign informed consent
- Need of sedative medication
- History of motion sickness
- History of psychiatric disease such as paranoia, schizophrenia, deep water phobia and dementia
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 |
|---|---|---|
| OnComfort autohypnosisParticipant arrive in our day care clinic and is prepared as any other patient in interventional radiology. The investigator will collect the signed informed consent form and proceed to randomization. The participant will then fill the pre and post-operative anxiety and pain questionnaire. The percutaneous vascular procedure will be performed as usual except for the virtual reality mask and autohypnosis software that will run during the whole intervention. Pain and anxiolytic medication are provided if needed during the intervention. Immediately after the intervention, the participant will fill the post-operative anxiety and pain questionnaire. The participant will be instructed to report anxiety and pain felt during the intervention. A clinical visit at 3 month is conducted as part of the standard clinical protocol. The participant will fill a 3rd questionnaire about the remembered anxiety and pain during the intervention. | Device | Autohypnosis |
| Treatment as usual, without the OnComfort autohypnosis systemThe Participant arrive in our day care clinic and is prepared as any other patient in interventional radiology. The investigator will collect the signed informed consent form and proceed to randomization. The participant will then fill the pre and post-operative anxiety and pain questionnaire. The percutaneous vascular procedure will be performed as usual. Pain and anxiolytic medication are provided if needed during the intervention. Immediately after the intervention, the participant will fill the post-operative anxiety and pain questionnaire. The participant will be instructed to report anxiety and pain felt during the intervention. A clinical visit at 3 month is conducted as part of the standard clinical protocol. The participant will fill a 3rd questionnaire about the remembered anxiety and pain during the intervention. | Other | Control |
Primary outcome
Per procedural anxiety.
Time frame: Day 1 (Immediately after the peripheral vascular intervention)
Per procedural anxiety, measured by the Spielberger Anxiety State Inventory in French (Gauthier and Bouchard, 1993). The Spielberger Anxiety State Inventory is a self questionnaire of 20 items, each item scores from 1 to 4. The result of the test is the sum of the 20 items, therefore the result ranges from 20 to 80. A high score is related to a high level of anxiety at the moment of the test.
5 secondary outcomes
Per procedural pain.
Time frame: Day 1 (Immediately after the peripheral vascular intervention)
Remembered per procedural anxiety.
Time frame: 3 months
Remembered per procedural pain.
Time frame: 3 months
Adverse events
Time frame: Day 1
Serious adverse events
Time frame: Day 90
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 30 Sep 2022.
- Derived from this study: PubMed 36944851Gullo G, Rotzinger DC, Colin A, Frossard P, Gudmundsson L, Jouannic AM, Qanadli SD. Virtually Augmented Self-Hypnosis in Peripheral Vascular Intervention: A Randomized Controlled Trial. Cardiovasc Intervent Radiol. 2023 Jun;46(6):786-793. doi: 10.1007/s00270-023-03394-1. Epub 2023 Mar 21.
- Derived from this study: PubMed 35196310Qanadli SD, Gudmundsson L, Gullo G, Ponti A, Saltiel S, Jouannic AM, Faouzi M, Rotzinger DC. Virtually Augmented Self-Hypnosis applied to endovascular interventions (VA-HYPO): Randomized Controlled Trial Protocol. PLoS One. 2022 Feb 23;17(2):e0263002. doi: 10.1371/journal.pone.0263002. eCollection 2022.
- 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.
Salah Dine Qanadli, Prof. MD PhD study director
Unil, CHUV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OnComfort autohypnosis and Treatment as usual, without the OnComfort autohypnosis system in people with Anxiety Postoperative and Pain, Postoperative, run by Salah D. Qanadli, MD, PhD at 1 site in Switzerland.
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 3 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 30 Sep 2022. 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 Switzerland. 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?
Per procedural anxiety. (time frame: Day 1 (Immediately after the peripheral vascular intervention)). 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 NCT04561596, 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 30 Sep 2022.