AplasiaHyp_HemNCT04794608
Hypnosis in Virtual Reality in Patients in Protector Isolation Room for Aplasia in Clinical Hematology.
A study testing HYPNO VR® device in people with Aplasia, run by Hôpital Privé Sévigné at 1 site in France.
Trial summary
Hematology patients are frequently treated in hospital for aplasia. Patients are then placed in protective isolation room. This situation of protective isolation can represent a significant source of stress and anxiety for the patient. Hypnosis is already used to treat anxiety in patients with cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aplasia
- What is being tested?
- HYPNO VR® device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jun 2021to 28 Feb 2024
- 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
- Patient aged ≥ 18 years.
- Haematological pathology
- Patient hospitalized in protective isolation for aplasia defined by a rate of polymorphonuclear neutrophils <0.5 G / L.
- Patient having signed his informed consent.
- Patient with social security coverage.
- Patient treated and monitored in the center for the duration of the study (maximum 1 month)
Who cannot join
- Patient unable to undergo protocol monitoring for psychological, social, family or geographic reasons.
- Patient deprived of his liberty or under guardianship.
- Patient with an underlying or concomitant pathology incompatible with inclusion in the trial, whether psychiatric or somatic
- Patient with a contraindication to the use of virtual reality (psychiatric disorders, unbalanced epilepsy, visual or hearing disorders).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hypnosis in Virtual Reality in Patients in Protector Isolation Room for Aplasia in Clinical Hematology. Monocentric, Comparative, Randomized, Open Study.
Hematology patients are frequently treated in hospital for aplasia. Patients are then placed in protective isolation room. This situation of protective isolation can represent a significant source of stress and anxiety for the patient. Hypnosis is already used to treat anxiety in patients with cancer.
The purpose of this study is to evaluate the impact of virtual reality medical hypnosis sessions on anxiety and chronic pain of patients hospitalized for aplasia in order to broaden the supportive care proposals in the clinical hematology service of Sévigné Private Hospital.
Read the detailed description
After verifying the patient's eligibility criteria and obtaining the signed informed consent form, the patient is randomized to the arm receiving hypnosis in virtual reality or to the control arm. The study ends after three consecutive days in protector isolation with one session hypnosis in virtual reality per day.
- Conditions
- Aplasia
- Being tested
- HYPNO VR® device
- Keywords
- Aplasia, Anxiety, Hypnosis, Virtual reality, Protector isolation
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HYPNO VR® deviceDevice
The HYPNO VR® device is a software application of medical hypnosis in the treatment of pain and anxiety. It is associated with equipment: a virtual reality headset and a headphone.
Before each session of hypnosis, the nursing staff offers patients the choices: visual universe, musical theme, male or female voice. The nursing staff selects the program, selects a duration of 20 minutes and presses start to start the medical hypnosis session in virtual reality.
After completing the hypnotic trance sequence, as in a classic session, the patient is brought back to the "return" and exit hypnosis phase under the supervision of the nursing staff.
| Study group | Role | What they receive |
|---|---|---|
| HypnoVR Arm | Experimental | During the three days of study in protector isolation, patients benefit from a 20-minute session of medical hypnosis in virtual reality. Receives: Device: HYPNO VR® device |
| Control Arm | No intervention | During the three days of study in protector isolation, patients benefit from a 20-minute session of activity among those currently proposed in the service of hematology (reading, music, television). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the change in anxiety in the HYPNOVR group versus the change in anxiety in the "selected activity" control group.
Comparison of the change in the anxiety "state" by the State Trait Anxiety Inventory (STAI) - State score before (15 minutes) and after (15 minutes) each virtual reality hypnosis session for 3 consecutive days (ie six questionnaires) to the change in the anxiety "state" in patients in the control group (STAI-State score evaluated 15 minutes before and 15 minutes after the patient was offered an activity of his choice). The score is a quantitative variable with values ranging from 20 to 80. The higher the score is, the more important the anxiety is.
Measured: For up to 3 days, every days (before and after the virtual reality hypnosis sessions), starting on day of inclusion.
Secondary outcomes (4)
Test the hypothesis that medical hypnosis in virtual reality is accompagnied by a variation of the chronic pain (in comparision with a control group).
Comparison of the change in chronic pain before and after each hypnosis session for the Hypno VR group, for 3 consecutive days, i.e. six assessments, in comparison with change in chronic pain in patients in the control group (also six assessments). The scale used is the visual analogical scale of pain which comes in the form of a ruler on which a cursor can be moved from end to end (from "no pain" to "maximum imaginable pain"). The rear face of the ruler, intended for the evaluator, has a graduation from 0 to 100 mm. The higher the score is, the more important the pain is.
Measured: For up to 3 days, every days (before and after the virtual reality hypnosis sessions), starting on day of inclusion.
Test the hypothesis that medical hypnosis in virtual reality is accompanied by a modification in the consumption of analgesic treatments (in comparision with a control group).
Comparison of the proportion of analgesic treatments consumption (posology stopped, added or changed) for each day of the study between the two arms.
Measured: For up to 3 days, every days (record before the virtual reality hypnosis sessions), starting on day of inclusion.
Test the hypothesis that medical hypnosis in virtual reality is accompanied by a modification in the consumption of anxiolytics treatments (in comparision with a control group).
Comparison of the proportion of anxiolytics treatments consumption (posology stopped, added or changed) for each day of the study between the two arms.
Measured: For up to 3 days, every days (record before the virtual reality hypnosis sessions), starting on day of inclusion.
Test the hypothesis that medical hypnosis in virtual reality is accompagnied by a good patient satisfaction regarding the use of the virtual reality headset.
Assessment of the overall satisfaction of the patient in the HYPNO VR group by the satisfaction questionnaire (ie a questionnaire after each hypnosis session for 3 consecutive days). A level of satisfaction (on a 11-point scale from 0 to 10) of the patient will be measure for the state of relaxation, security, understanding, overall satisfaction.
Measured: For up to 3 days, every days (record after the virtual reality hypnosis sessions), starting on day of inclusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start17 Jun 2021
- Primary completion30 Jan 2024
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AplasiaStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital Privé Sévigné
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne-Violaine DONCKER, MD, Principal investigator, Hôpital Privé Sévigné
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04794608
- Sponsor's protocol ID
- 2020-A02561-38
- Acronym
- Hyp_Hem
- Status last verified
- Feb 2025
- First submitted
- 3 Mar 2021
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Doncker AV, Cahu X, Bareau B, Masset S. Virtual reality hypnosis during protective isolation: a parallel group randomized trial. Support Care Cancer. 2026 Aug 24;34(9):895. doi: 10.1007/s00520-026-11099-7.
PubMed 42635826
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypnosis in Virtual Reality in Patients in Protector Isolation Room for Aplasia in Clinical Hematology. Monocentric, Comparative, Randomized, Open Study.
- ClinicalTrials.gov ID
- NCT04794608
- Acronym / sponsor ID
- Hyp_Hem / 2020-A02561-38
- Conditions
- Aplasia
- Keywords
- Aplasia, Anxiety, Hypnosis, Virtual reality, Protector isolation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hôpital Privé SévignéUniversity, hospital or other
- Study start
- 17 Jun 2021 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 12 Mar 2021 (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.
Hematology patients are frequently treated in hospital for aplasia. Patients are then placed in protective isolation room. This situation of protective isolation can represent a significant source of stress and anxiety for the patient. Hypnosis is already used to treat anxiety in patients with cancer.
The purpose of this study is to evaluate the impact of virtual reality medical hypnosis sessions on anxiety and chronic pain of patients hospitalized for aplasia in order to broaden the supportive care proposals in the clinical hematology service of Sévigné Private Hospital.
Detailed description
After verifying the patient's eligibility criteria and obtaining the signed informed consent form, the patient is randomized to the arm receiving hypnosis in virtual reality or to the control arm. The study ends after three consecutive days in protector isolation with one session hypnosis in virtual reality per day.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HypnoVR Arm | Experimental | Device: HYPNO VR® deviceDuring the three days of study in protector isolation, patients benefit from a 20-minute session of medical hypnosis in virtual reality. |
| Control Arm | No intervention | –During the three days of study in protector isolation, patients benefit from a 20-minute session of activity among those currently proposed in the service of hematology (reading, music, television). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient aged ≥ 18 years.
- Haematological pathology
- Patient hospitalized in protective isolation for aplasia defined by a rate of polymorphonuclear neutrophils <0.5 G / L.
- Patient having signed his informed consent.
- Patient with social security coverage.
Key exclusion criteria (4 listed)
- Patient unable to undergo protocol monitoring for psychological, social, family or geographic reasons.
- Patient deprived of his liberty or under guardianship.
- Patient with an underlying or concomitant pathology incompatible with inclusion in the trial, whether psychiatric or somatic
- Patient with a contraindication to the use of virtual reality (psychiatric disorders, unbalanced epilepsy, visual or hearing disorders).
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 |
|---|---|---|
| HYPNO VR® deviceThe HYPNO VR® device is a software application of medical hypnosis in the treatment of pain and anxiety. It is associated with equipment: a virtual reality headset and a headphone. Before each session of hypnosis, the nursing staff offers patients the choices: visual universe, musical theme, male or female voice. The nursing staff selects the program, selects a duration of 20 minutes and presses start to start the medical hypnosis session in virtual reality. After completing the hypnotic trance sequence, as in a classic session, the patient is brought back to the "return" and exit hypnosis phase under the supervision of the nursing staff. | Device | HypnoVR Arm |
Primary outcome
Compare the change in anxiety in the HYPNOVR group versus the change in anxiety in the "selected activity" control group.
Time frame: For up to 3 days, every days (before and after the virtual reality hypnosis sessions), starting on day of inclusion.
Comparison of the change in the anxiety "state" by the State Trait Anxiety Inventory (STAI) - State score before (15 minutes) and after (15 minutes) each virtual reality hypnosis session for 3 consecutive days (ie six questionnaires) to the change in the anxiety "state" in patients in the control group (STAI-State score evaluated 15 minutes before and 15 minutes after the patient was offered an activity of his choice). The score is a quantitative variable with values ranging from 20 to 80. The higher the score is, the more important the anxiety is.
4 secondary outcomes
Test the hypothesis that medical hypnosis in virtual reality is accompagnied by a variation of the chronic pain (in comparision with a control group).
Time frame: For up to 3 days, every days (before and after the virtual reality hypnosis sessions), starting on day of inclusion.
Test the hypothesis that medical hypnosis in virtual reality is accompanied by a modification in the consumption of analgesic treatments (in comparision with a control group).
Time frame: For up to 3 days, every days (record before the virtual reality hypnosis sessions), starting on day of inclusion.
Test the hypothesis that medical hypnosis in virtual reality is accompanied by a modification in the consumption of anxiolytics treatments (in comparision with a control group).
Time frame: For up to 3 days, every days (record before the virtual reality hypnosis sessions), starting on day of inclusion.
Test the hypothesis that medical hypnosis in virtual reality is accompagnied by a good patient satisfaction regarding the use of the virtual reality headset.
Time frame: For up to 3 days, every days (record after the virtual reality hypnosis sessions), starting on day of inclusion.
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 6 Feb 2025.
- Derived from this study: PubMed 42635826Doncker AV, Cahu X, Bareau B, Masset S. Virtual reality hypnosis during protective isolation: a parallel group randomized trial. Support Care Cancer. 2026 Aug 24;34(9):895. doi: 10.1007/s00520-026-11099-7.
- 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.
Anne-Violaine DONCKER, MD principal investigator
Hôpital Privé Sévigné
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HYPNO VR® device in people with Aplasia, run by Hôpital Privé Sévigné at 1 site in France.
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 6 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: finished, as of the sponsor's last update on 6 Feb 2025. 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 France. 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?
Compare the change in anxiety in the HYPNOVR group versus the change in anxiety in the "selected activity" control group. (time frame: For up to 3 days, every days (before and after the virtual reality hypnosis sessions), starting on day of inclusion.). 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 NCT04794608, which also lists 1 linked publication.
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 6 Feb 2025.