CancerVRH-PACNCT06883786
Effects of Virtual Reality Hypnosis on Anxiety, Pain and Comfort in Oncology Patients During a Port-catheter Placement Procedure
A study testing Virtual reality hypnosis in people with Cancer, run by University of Liege at 2 sites in Belgium.
Trial summary
The port-catheter (PAC) is a longterm venous access device, frequently used in oncology patients. The PAC is an invasive technique, consisting of a reservoir surgically implanted in the chest wall or upper arm, and arm and a catheter. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cancer
- What is being tested?
- Virtual reality hypnosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 2 sitesBelgium
- Study dates
- Apr 2025to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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.
- Dizziness.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium2 sites
CHR de Huy
Huy, Liège, 4500
Jean-François Dr. Maillart, M.D., +3285277154, jf.maillart@gmail.com
CHU of Liège
Liège, Liège, 4000
Aminata Bicego, PhD, 003243663499, abicego@uliege.be
Audrey Vanhaudenhuyse, PI, 003243668033, avanhaudenhuyse@chuliege.be
About this study
Official title: Interest of Virtual Reality Hypnosis to Decrease Anxiety, Pain, and Discomfort of Patients With Cancer Having to Undergo an Invasive Intervention
The port-catheter (PAC) is a longterm venous access device, frequently used in oncology patients. The PAC is an invasive technique, consisting of a reservoir surgically implanted in the chest wall or upper arm, and arm and a catheter. Patients can experience pain in the incision area after implantation, as well as anxiety before, during and after implantation. Virtual reality hypnosis (VRH) is an innovative technique delivering clinical hypnosis to patients through virtual reality (VR). The clinical applications of VRH are still little known. We will assess the anxiety, comofrt, pain perception and pain unpleasantness of 102 cancer patients scheduled to receive a PAC. The patients will be randomly divided into two groups. Thefirst group will benefit from the usual care for the placement of the PAC (i.e., local anaesthesia), while the second will benefit from the VRH in addition to the usual care. Pain perception, pain unpleasantness, anxiety, satisfaction, absorption, dissociation will be evaluated before and after the intervention.
- Conditions
- Cancer
- Being tested
- Virtual reality hypnosis
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality hypnosisDevice
Virtual reality hypnosis
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality hypnosis | Experimental | The VRH session, called Aqua+© (120 Version 1.1, HypnoVR SAS, Strasbourg, France) It is an immersive and contemplative virtual experience combining music, sounds, and/or a vocal audio recording relating a hypnotic scenario and a 3D virtual video. The Aqua© VRH session follows the standard phases of hypnosis, beginning with induction, followed by suggestions, and ending with the exit of hypnosis. Receives: Device: Virtual reality hypnosis |
| Control | No intervention | Usual care. Local anesthesia only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety state
Anxiety state will be assessed using a numerical rating scale (NRS) ranging from 0 (no anxiety) to 10 (worst anxiety ever).
Measured: Before PAC intervention, immediately after PAC intervention
Pain intensity
Pain intensity will be assessed using a numerical rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).
Measured: Before PAC intervention, immediately after PAC intervention
Pain unpleasantness
Pain unpleasantness will be assessed using a numerical rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).
Measured: Before PAC intervention, immediately after PAC intervention
Comfort
Comfort will be assessed using a numerical rating scale (NRS) ranging from 0 (no comfort) to 10 (maximum comfort).
Measured: Before PAC intervention, immediately after PAC intervention
Secondary outcomes (12)
Anxiety trait
The State-Trait Anxiety Inventory (STAI - Y) will be used to assess trait anxiety only. Originally this questionnaire has two parts one dedicated to assess state anxiety and another to assess the trait anxiety. Only the latter was used in this study. STAI - Y Trait contains 20 items with 4 response options (1 = almost never, 2 = sometimes, 3 = often, 4 = almost always). Total scores can range from 20 to 80, with higher scores indicating a higher level of anxiety.
Measured: From the day of the group assignment until beginning the PAC intervention, assessed up to two weeks
Dissociation trait
The Dissociative Experience Scale is a self-reported questionnaire used to evaluate the presence, quantity, and type of dissociative experiences one might live in daily life. It consists of 28 items arranged on an analog scale (from 0 to 100% measuring the frequency of dissociative experiences), and the total score ranges from 0 to 100. There is a cutoff of 45 as a mean score to suggest a dissociative disorder. This questionnaire is not a diagnostic instrument; it is designed only for screening, but it can suggest that a specific clinical assessment is needed.
Measured: From the day of the group assignment until beginning the PAC intervention, assessed up to two weeks
Dissociation state
Dissociation will be assessed using a numerical rating scale (NRS) ranging from 0 (no dissociation) to 10 (maximum dissociation).
Measured: From the day of the group assignment until completion of the PAC intervention, assessed up to two weeks
Absorption trait
The Tellegen Absorption Scale consists of 34 true/false items , aiming to measure the absorption of a person, meaning the disposition for having episodes of a deep involvement that engage all the subject's resources (perceptual, imaginative, and cognitive). The total score range is from 0 to 34. The higher the score, the more one has a high propensity for absorption.
Measured: From the day of the group assignment until beginning the PAC intervention, assessed up to two weeks
Absorption state
Absorption will be assessed using a numerical rating scale (NRS) ranging from 0 (no Absorption) to 10 (maximum Absorption).
Measured: From the day of the group assignment until completion of the PAC intervention, assessed up to two weeks
Time perception
Time perception will be assessed with an open-ended question.
Measured: From the day of the group assignment until completion of the PAC intervention, assessed up to two weeks
Immersion tendencies
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: From the day of the group assignment until beginning the PAC intervention, assessed up to two weeks
Satisfaction of the participant
Satisfaction will be assessed using a numerical rating scale (NRS) ranging from 0 (dissatisfied) to 10 (best satisfaction ever).
Measured: From the day of the group assignment until completion of the PAC intervention, assessed up to two weeks
Satisfaction of the surgeon
Satisfaction will be assessed using a numerical rating scale (NRS) ranging from 0 (dissatisfied) to 10 (best satisfaction ever).
Measured: From the day of the group assignment until completion of the PAC intervention, assessed up to two weeks
Medication
The medication will be collected in the medical record of the surgery.
Measured: During PAC intervention, 24 hours after PAC intervention, 48 hours after PAC, 7 days after PAC
Surgery duration
The duration of the surgery will be collected in the medical record of the surgery.
Measured: From the day of the group assignment until completion of the PAC intervention, assessed up to two weeks
Fatigue
Fatigue will be assessed using a numerical rating scale (NRS) ranging from 0 (no fatigue) to 10 (worst fatigue ever).
Measured: 24 hours after PAC intervention, 48 hours after PAC, 7 days after PAC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study startApr 2025 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionFeb 2027 (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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Collaborators
- HypnoVR, Centre Hospitalier Regional de Huy, Centre Hospitalier Universitaire de Liege
- Responsible party
- Principal investigator, Audrey Vanhaudenhuyse, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06883786
- Sponsor's protocol ID
- VRH-PAC
- Acronym
- VRH-PAC
- Status last verified
- Mar 2025
- First submitted
- 15 Feb 2024
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Virtual Reality Hypnosis to Decrease Anxiety, Pain, and Discomfort of Patients With Cancer Having to Undergo an Invasive Intervention
- ClinicalTrials.gov ID
- NCT06883786
- Acronym / sponsor ID
- VRH-PAC / VRH-PAC
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Collaborators
- HypnoVR, Centre Hospitalier Regional de Huy, Centre Hospitalier Universitaire de Liege
- Study start
- Apr 2025 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 19 Mar 2025 (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 port-catheter (PAC) is a longterm venous access device, frequently used in oncology patients. The PAC is an invasive technique, consisting of a reservoir surgically implanted in the chest wall or upper arm, and arm and a catheter. Patients can experience pain in the incision area after implantation, as well as anxiety before, during and after implantation. Virtual reality hypnosis (VRH) is an innovative technique delivering clinical hypnosis to patients through virtual reality (VR). The clinical applications of VRH are still little known. We will assess the anxiety, comofrt, pain perception and pain unpleasantness of 102 cancer patients scheduled to receive a PAC. The patients will be randomly divided into two groups. Thefirst group will benefit from the usual care for the placement of the PAC (i.e., local anaesthesia), while the second will benefit from the VRH in addition to the usual care. Pain perception, pain unpleasantness, anxiety, satisfaction, absorption, dissociation will be evaluated before and after the intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual reality hypnosis | Experimental | Device: Virtual reality hypnosisThe VRH session, called Aqua+© (120 Version 1.1, HypnoVR SAS, Strasbourg, France) It is an immersive and contemplative virtual experience combining music, sounds, and/or a vocal audio recording relating a hypnotic scenario and a 3D virtual video. The Aqua© VRH session follows the standard phases of hypnosis, beginning with induction, followed by suggestions, and ending with the exit of hypnosis. |
| Control | No intervention | –Usual care. Local anesthesia only. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 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.
Key exclusion criteria (0 listed)
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 hypnosisVirtual reality hypnosis | Device | Virtual reality hypnosis |
Primary outcome
Anxiety state
Time frame: Before PAC intervention, immediately after PAC intervention
Anxiety state will be assessed using a numerical rating scale (NRS) ranging from 0 (no anxiety) to 10 (worst anxiety ever).
Pain intensity
Time frame: Before PAC intervention, immediately after PAC intervention
Pain intensity will be assessed using a numerical rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).
Pain unpleasantness
Time frame: Before PAC intervention, immediately after PAC intervention
Pain unpleasantness will be assessed using a numerical rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).
Comfort
Time frame: Before PAC intervention, immediately after PAC intervention
Comfort will be assessed using a numerical rating scale (NRS) ranging from 0 (no comfort) to 10 (maximum comfort).
12 secondary outcomes
Anxiety trait
Time frame: From the day of the group assignment until beginning the PAC intervention, assessed up to two weeks
Dissociation trait
Time frame: From the day of the group assignment until beginning the PAC intervention, assessed up to two weeks
Dissociation state
Time frame: From the day of the group assignment until completion of the PAC intervention, assessed up to two weeks
Absorption trait
Time frame: From the day of the group assignment until beginning the PAC intervention, assessed up to two weeks
Absorption state
Time frame: From the day of the group assignment until completion of the PAC intervention, assessed up to two weeks
Time perception
Time frame: From the day of the group assignment until completion of the PAC intervention, assessed up to two weeks
Immersion tendencies
Time frame: From the day of the group assignment until beginning the PAC intervention, assessed up to two weeks
Satisfaction of the participant
Time frame: From the day of the group assignment until completion of the PAC intervention, assessed up to two weeks
Satisfaction of the surgeon
Time frame: From the day of the group assignment until completion of the PAC intervention, assessed up to two weeks
Medication
Time frame: During PAC intervention, 24 hours after PAC intervention, 48 hours after PAC, 7 days after PAC
Surgery duration
Time frame: From the day of the group assignment until completion of the PAC intervention, assessed up to two weeks
Fatigue
Time frame: 24 hours after PAC intervention, 48 hours after PAC, 7 days after PAC
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality hypnosis in people with Cancer, run by University of Liege at 2 sites 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 7 inclusion and 0 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: opening soon, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Audrey Vanhaudenhuyse, PhD (+ 32 43 23 80 33, avanhaudenhuyse@chuliege.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety state (time frame: Before PAC intervention, immediately after PAC intervention). The study lists 4 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 19 Mar 2025.