CancerNCT05362708
Neurophysiological Correlates of Dissociation Induced by Virtual Reality Hypnosis (VRH) in a Clinical Population
A study testing Clinical - Hypnosis with VR (VRH) in people with Cancer, run by University of Liege.
Trial summary
Hypnosis and virtual reality are potential tools for treating acute. Nevertheless, the neurophysiological correlates of such tools used together, i.e. 'virtual reality hypnosis' (VRH) (Patterson et al., 2004) remain mostly understudied. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cancer
- What is being tested?
- Clinical - Hypnosis with VR (VRH)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2022to 1 Oct 2023
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Low auditory and/or visual acuity precludes the use of the device.
- Head or face wounds precluding the use of the device.
- Schizophrenia, dissociative disorder or any other psychiatric disorder.
- Non-proficiency in French (Research language).
- Patient under 18 years old.
- Phobia of deep water.
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- Allergy to cutaneous electrodes.
- Chronic pain and/or chronic analgesics consumption.
- Medication affecting the autonomic nervous system.
- Dizziness.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Neurophysiological Correlates of Dissociation Induced by Virtual Reality Hypnosis (VRH) in an Oncological Population
Hypnosis and virtual reality are potential tools for treating acute. Nevertheless, the neurophysiological correlates of such tools used together, i.e. 'virtual reality hypnosis' (VRH) (Patterson et al., 2004) remain mostly understudied. This study aims to improve our knowledge and understanding of the dissociation (i.e., a mental separation of components of behaviours that normally would be processed together) occurring during VRH. This is a clinical trial aiming at understanding if the VRH reduces pain during a port-a-cath intervention in oncological patients and if dissociation may explain the pain alteration.
Read the detailed description
The study will be focused on oncological patients undergoing a port-a-cath placement procedure. Day-1 and Day-2 with a one-day follow-up Day-3:
- Day-1: Oncological Population (Feasibility)
- Recruitment and questionnaires on the day of the port-a-cath preparation consultation (DAY-1): i. A medical screening will be performed to assess eligibility, ii. Elkins Hypnotizability Scale. iii. State Trait Anxiety Inventory-trait (anxiety trait) iv. Dissociative Experience Scale. v. Tellegen Absorption Scale. vi. Questionnaire of Immersion Propensity.
II. Day-2:
- Intervention day:
- Visual Analogy Scale:
- Anxiety.
- Pain. ii. 4-Electrodes EEG device from Oncomfort during port-a-cath (Port) placement procedure under Virtual Reality Hypnosis (VRH), combined standard monitoring (spO2, heart rate, etc.) iii. Adverse events will be recorded throughout the experiment iv. Visual Analogy Scale:
- Dissociation.
- Pain.
- Anxiety
- Absorption.
- Arousal/wakefulness.
- Automaticity v. Time Perception (open-ended question) vi. Presence questionnaire. vii. Satisfaction questionnaire.
- Follow-up (DAY-3):
- A follow-up questionnaire using the Brief Pain Inventory (BPI) French version will be sent to the patient one week after the intervention to measure outcomes.
- Conditions
- Cancer
- Being tested
- Clinical - Hypnosis with VR (VRH)
- Keywords
- Virtual Reality, Hypnosis, Dissociation
- Medical subject headings
- Neoplasms, Dissociative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical - Hypnosis with VR (VRH)Device
The VRH intervention will use the Aqua video session developed by Oncomfort during a port-a-cath procedure.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group - VRH | Experimental | Patients will receive VRH during port-a-cath (Port) placement Receives: Device: Clinical - Hypnosis with VR (VRH) |
| Control Group | No intervention | Patients who do not want to receive the VRH but who accept to answer the questionnaires will be considered as a control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dissociation state
Corresponds to a dissociation between the bodily sensations and the actual environment that one feels in a particular situation. will be assessed with a numerical rating scale (0= no dissociation; 10 = dissociation from environment).
Measured: During the procedure
Pain intensity
The amount of pain one experiences in a particular situation. Will be assessed with a visual analogy scale, 0= no pain at all; 10= worst pain imaginable.
Measured: During the procedure
Secondary outcomes (14)
Dissociation trait
The amount of dissociation one experiences in one's daily life. Will be assessed with the Dissociative Experience Scale, the higher the score, the more one experiences dissociation in one's daily life.
Measured: During the procedure
Hypnotisability
The susceptibility one has concerning hypnosis. Will be assessed with the Elkins Hypnotizability Scale. A score :
0-3 : low hypnotizability 4-7: medium hypnotizability 8-11 : high hypnotizability 12 : very high hypnotizability
Measured: During the procedure
Absorption trait
The tendency to become fully involved in a perceptual, imaginative or ideational experience. Will be assessed with the Tellegen Absorption Scale, the higher the score the higher the absorption in the daily life.
Measured: During the procedure
Anxiety trait
Level of anxiety one experiences in one's daily life. Will be assessed with the State Trait Anxiety Invetory (STAI)-6 questionnaire. The higher the score, the higher the anxiety one feels in one's daily life.
Measured: During the procedure
Immersion propensity (trait)
Immersion propensity is the amount of sensory input the virtual reality system creates. Will be assessed with the Immersion Propensity questionnaire. The higher the score, the more one is immersed in the virtual environments.
Measured: During the procedure
Anxiety state
The amount of anxiety one experiences in a particular situation. Will be assessed with a visual analogy scale. a score = 0 means no anxiety at all, while a score = 10 means most anxiety ever felt.
Measured: During the procedure
Absorption state
The amount of absorption one experiences in a particular situation. Will be assessed with a numerical rating scale, 0 = no absorption; 10 = fully absorption by the experience.
Measured: During the procedure
Automaticity
A non-voluntary response related to the content of a communication that is intended to be a suggestion. Will be assessed with a numerical rating scale : 0= perfect control; 10 = passive witness.
Measured: During the procedure
Arousal/wakefulness
The amount of arousal one experiences in a particular situation. Will be assessed with a visual analogy scale, 0=not aroused, awaken; 10 = completely aroused, awake.
Measured: During the procedure
Time perception
Open-ended question about one's impression of the duration of the VHR and HYP sessions.
Measured: During the procedure
Cybersickness
Assesses the sickness one might experience after the VRH. Will be assessed with the Cybersickness questionnaire. The higher the score, the more one has experience sickness during the VRH.
Measured: During the procedure
Presence
Refers to the degree to which the subject experiences being in the virtual environment. Will be assessed with the presence questionnaire, the higher the score the higher one has the feeling of really being in the virtual environment.
Measured: During the procedure
Satisfaction of the participant
Assesses the overall satisfaction one has had with the VRH and HYP session. Will be assessed by a self-made satisfaction questionnaire, the higher the score, the more one is satisfied with the experience.
Measured: During the procedure
Brief Pain Inventory
The BPI measures the intensity of pain and interference of pain in the patient's life. The higher the scores the higher the intensity and interference.
Measured: One week after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start1 May 2022 (estimated)
- Primary completion1 Apr 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients who are not interested will be considered as a control group.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Collaborators
- Oncomfort, Biowin
- Responsible party
- Principal investigator, Audrey Vanhaudenhuyse, University of Liege
- Investigators
- Audrey ANHAUDENHUYSE, PhD, Principal investigator, Centre Hospitalier Universitaire de Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05362708
- Sponsor's protocol ID
- QuDDoS - Phase-II
- Status last verified
- May 2022
- First submitted
- 13 Apr 2022
- Last updated
- 5 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurophysiological Correlates of Dissociation Induced by Virtual Reality Hypnosis (VRH) in an Oncological Population
- ClinicalTrials.gov ID
- NCT05362708
- Acronym / sponsor ID
- QuDDoS - Phase-II
- Conditions
- Cancer
- Keywords
- Virtual Reality, Hypnosis, Dissociation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Collaborators
- Oncomfort, Biowin
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 5 May 2022 (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.
Hypnosis and virtual reality are potential tools for treating acute. Nevertheless, the neurophysiological correlates of such tools used together, i.e. 'virtual reality hypnosis' (VRH) (Patterson et al., 2004) remain mostly understudied. This study aims to improve our knowledge and understanding of the dissociation (i.e., a mental separation of components of behaviours that normally would be processed together) occurring during VRH. This is a clinical trial aiming at understanding if the VRH reduces pain during a port-a-cath intervention in oncological patients and if dissociation may explain the pain alteration.
Detailed description
The study will be focused on oncological patients undergoing a port-a-cath placement procedure. Day-1 and Day-2 with a one-day follow-up Day-3:
- Day-1: Oncological Population (Feasibility)
- Recruitment and questionnaires on the day of the port-a-cath preparation consultation (DAY-1): i. A medical screening will be performed to assess eligibility, ii. Elkins Hypnotizability Scale. iii. State Trait Anxiety Inventory-trait (anxiety trait) iv. Dissociative Experience Scale. v. Tellegen Absorption Scale. vi. Questionnaire of Immersion Propensity.
II. Day-2:
- Intervention day:
- Visual Analogy Scale:
- Anxiety.
- Pain. ii. 4-Electrodes EEG device from Oncomfort during port-a-cath (Port) placement procedure under Virtual Reality Hypnosis (VRH), combined standard monitoring (spO2, heart rate, etc.) iii. Adverse events will be recorded throughout the experiment iv. Visual Analogy Scale:
- Dissociation.
- Pain.
- Anxiety
- Absorption.
- Arousal/wakefulness.
- Automaticity v. Time Perception (open-ended question) vi. Presence questionnaire. vii. Satisfaction questionnaire.
- Follow-up (DAY-3):
- A follow-up questionnaire using the Brief Pain Inventory (BPI) French version will be sent to the patient one week after the intervention to measure outcomes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients who are not interested will be considered as a control group.
| Arm | Type | Receives |
|---|---|---|
| Experimental group - VRH | Experimental | Device: Clinical - Hypnosis with VR (VRH)Patients will receive VRH during port-a-cath (Port) placement |
| Control Group | No intervention | –Patients who do not want to receive the VRH but who accept to answer the questionnaires will be considered as a control group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- Low auditory and/or visual acuity precludes the use of the device.
- Head or face wounds precluding the use of the device.
- Schizophrenia, dissociative disorder or any other psychiatric disorder.
- Non-proficiency in French (Research language).
- Patient under 18 years old.
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 |
|---|---|---|
| Clinical - Hypnosis with VR (VRH)The VRH intervention will use the Aqua video session developed by Oncomfort during a port-a-cath procedure. | Device | Experimental group - VRH |
Primary outcome
Dissociation state
Time frame: During the procedure
Corresponds to a dissociation between the bodily sensations and the actual environment that one feels in a particular situation. will be assessed with a numerical rating scale (0= no dissociation; 10 = dissociation from environment).
Pain intensity
Time frame: During the procedure
The amount of pain one experiences in a particular situation. Will be assessed with a visual analogy scale, 0= no pain at all; 10= worst pain imaginable.
14 secondary outcomes
Dissociation trait
Time frame: During the procedure
Hypnotisability
Time frame: During the procedure
Absorption trait
Time frame: During the procedure
Anxiety trait
Time frame: During the procedure
Immersion propensity (trait)
Time frame: During the procedure
Anxiety state
Time frame: During the procedure
Absorption state
Time frame: During the procedure
Automaticity
Time frame: During the procedure
Arousal/wakefulness
Time frame: During the procedure
Time perception
Time frame: During the procedure
Cybersickness
Time frame: During the procedure
Presence
Time frame: During the procedure
Satisfaction of the participant
Time frame: During the procedure
Brief Pain Inventory
Time frame: One week after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
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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.
Audrey ANHAUDENHUYSE, PhD principal investigator
Centre Hospitalier Universitaire de Liege
Questions about this trial
What is this clinical trial studying?
A study testing Clinical - Hypnosis with VR (VRH) in people with Cancer, run by University of Liege.
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 0 inclusion and 10 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 5 May 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Aminata Bicego, PhD (+3243663499, abicego@uliege.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dissociation state (time frame: During the procedure). The study lists 2 primary outcomes in all. 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 5 May 2022; AzTrials last refreshed its copy on 8 Nov 2026.