Acute Myeloid LeukemiaHYPNO-RV LAMNCT07386392
Effect of Hypnosis and Virtual Reality on Anxiety During Treatment for Acute Myeloid Leukemia
A study testing Hypnosis and Virtual Reality in people with Acute Myeloid Leukemia, run by University Hospital, Toulouse at 1 site in France.
Trial summary
This is a pilot study comparing 3 arms (standard care with hypnosis / standard care with virtual reality / standard care alone), aimed at measuring the effect on anxiety during the induction treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Hypnosis and Virtual Reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2026to 31 Dec 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient over the age of 18
- Patient diagnosed with acute myeloid leukemia in Western Occitanie
- Eligible for first-line induction chemotherapy with anthracycline and cytarabine
- Patient able to understand and respond to a self-administered questionnaire
- Affiliated with or beneficiary of a social security system
- Having signed the research consent form
Who cannot join
- Patients diagnosed with acute myeloid leukemia 3
- Patients who were treated in intensive care prior to hospitalization for induction therapy or following induction therapy
- Patients with a diagnosed chronic pain-inducing disease (e.g., rheumatoid arthritis), if not stable
- Patients with a confirmed diagnosis of psychopathology such as psychosis, depression, or burnout, if not stable
- Patients suffering from epilepsy, whether treated or not, or with a history of epilepsy
- Patients under guardianship, conservatorship, or legal protection
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
IUCT Oncopole
Toulouse, France, 31059
Séverine SEAILLES, 0531156360 ext. 33, seailles.severine@chu-toulouse.fr
About this study
Official title: Effect of Medical Hypnosis Compared to Virtual Reality or Standard Care on Anxiety During Induction Treatment for Acute Myeloid Leukemia
This is a pilot study comparing 3 arms (standard care with hypnosis / standard care with virtual reality / standard care alone), aimed at measuring the effect on anxiety during the induction treatment. Acute myeloid leukemia is considered an oncological emergency that requires chemotherapy treatment with a high risk of serious adverse effects due to prolonged bone marrow failure or drug toxicity. This situation is very stressful for patients, who must cope with the initial symptoms, the diagnosis of a serious cancer, an urgent hospitalization (sometimes in intensive care) and prolonged hospitalization, invasive procedures for diagnosis and initiation of treatment, and intensive chemotherapy requiring protective isolation to contain the risk of life-threatening infection. Added to this care context is the breakdown of family ties as well as socio-professional ties, generating major anxiety and a risk of post-traumatic stress disorder (symptoms, which are common in acute myeloid leukemia. The hypothesis of our study is that hypnosis and virtual reality sessions combined with standard care could reduce anxiety and enhance chemotherapy treatment in acute myeloid leukemia patients when they first learn of their diagnosis.
Read the detailed description
Patients will be randomly assigned to one of the three arms. All patients will receive standard conventional chemotherapy treatments in accordance with international recommendations and standard conventional care (including supportive care) during their hospital stay. Depending on the group to which they are assigned, they will also participate in hypnotherapy or virtual reality sessions during their hospital stay. Patients will be asked to complete various self-administered questionnaires to measure their levels of anxiety, quality of life, and stress during the course of treatment, according to the study schedule
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Hypnosis, Virtual Reality
- Keywords
- Acute Myeloid Leukemia, Virtual reality, Anxiety, Chemotherapy, Post-traumatic stress, Quality of life, Supportive care
- Medical subject headings
- Leukemia, Myeloid, Acute, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypnosisOther
Each session is based on the hypnosis techniques described by Erickson. In general, a session includes a hypnotic induction phase, a period of deepening and suggestions specific to the symptoms, followed by a return to reality. The hypnotherapist will be someone outside the team, trained in the Ericksonian method, who will intervene at a specific time during the sessions.
Virtual RealityOther
Each patient will be able to choose their environment from among those available (forest, beach, Zen garden, scuba diving, winter landscape, northern lights, astral travel, Antarctica, Maldives, desert), accompanied by ambient sounds. During the sessions, patients will be seated in their rooms at a quiet time outside of any treatment.
| Study group | Role | What they receive |
|---|---|---|
| Hypnose | Experimental | Patients participate in six hypnosis sessions, each lasting 30 minutes, twice during the first and second weeks, then once a week for the following two weeks Receives: Other: Hypnosis |
| Virtual Reality | Experimental | Patients participate in nine virtual reality sessions, each lasting 20 minutes, three times during the first week, then twice a week for the following three weeks Receives: Other: Virtual Reality |
| Control | No intervention | Patients do not receive hypnosis sessions or virtual reality sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of an intervention combining standard care and virtual reality on the anxiety levels of patients at the end of induction chemotherapy for acute myeloid leukemia, compared to standard care and standard care with hypnosis
Change in anxiety score, measured using the Hospital Anxiety and Depression Scale
Measured: 35 days
Secondary outcomes (8)
Effect of an intervention combining standard care and virtual reality, compared to standard care and standard care with hypnosis, on nociceptive pain
Pain will be measured using a numerical pain scale at inclusion (first day of hospitalization)
Measured: 35 days
Evaluate the effect of an intervention combining standard care and virtual reality, compared to standard care and standard care with hypnosis, on anxiety
Change in anxiety scores using the Hospital Anxiety and Depression Scale
Measured: 3 months
Evaluate the effect of an intervention combining standard care and virtual reality, compared to standard care and standard care with hypnosis, on quality of life
Quality of life scores using the specific Fact-Leu questionnary
Measured: 3 months
Evaluate the effect of an intervention combining standard care and virtual reality, compared to standard care and standard care with hypnosis, on post-traumatic stress disorder
Post-traumatic stress disorder using the Posttraumatic Stress Disorder Checklist Scale
Measured: 3 months
Evaluate the effect of an intervention combining standard care and virtual reality, compared to standard care and standard care with hypnosis, on remission rate
Remission rate by sternal puncture, performed systematically (as part of routine care). A blast count of less than 5% will indicate remission
Measured: 35 days
Evaluate the effect of an intervention combining standard care and virtual reality, compared to standard care and standard care with hypnosis, on minimal residual disease
Minimal Residual Disease, using molecular biology or flow cytometry
Measured: 35 days
Evaluate the effect of an intervention combining standard care and virtual reality, compared to standard care and standard care with hypnosis, on consumption of analgesics and psychotropic drugs
Medication consumption based on cumulative doses and the number of days on analgesics and psychotropic drugs
Measured: 35 days
Evaluate the effect of an intervention combining standard care and virtual reality, compared to standard care and standard care with hypnosis, on occurrence of adverse events related to induction treatment
Adverse events related to induction treatment of Common Terminology Criteria for Adverse Events grade ≥ 3, as well as adverse events related to induction treatment such as nausea, vomiting, mucositis, diarrhea, weight loss, and alopecia, regardless of grade
Measured: 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start1 Feb 2026 (estimated)
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Collaborators
- Association Laurette Fugain, Ligue contre le cancer, France
- Responsible party
- Sponsor
- Investigators
- Suzanne TAVITIAN, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07386392
- Sponsor's protocol ID
- RC31/22/0010
- Acronym
- HYPNO-RV LAM
- Status last verified
- Jan 2026
- First submitted
- 26 Jan 2026
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Medical Hypnosis Compared to Virtual Reality or Standard Care on Anxiety During Induction Treatment for Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT07386392
- Acronym / sponsor ID
- HYPNO-RV LAM / RC31/22/0010
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Acute Myeloid Leukemia, Virtual reality, Anxiety, Chemotherapy, Post-traumatic stress, Quality of life, Supportive care
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- Association Laurette Fugain, Ligue contre le cancer, France
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 4 Feb 2026 (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.
This is a pilot study comparing 3 arms (standard care with hypnosis / standard care with virtual reality / standard care alone), aimed at measuring the effect on anxiety during the induction treatment. Acute myeloid leukemia is considered an oncological emergency that requires chemotherapy treatment with a high risk of serious adverse effects due to prolonged bone marrow failure or drug toxicity. This situation is very stressful for patients, who must cope with the initial symptoms, the diagnosis of a serious cancer, an urgent hospitalization (sometimes in intensive care) and prolonged hospitalization, invasive procedures for diagnosis and initiation of treatment, and intensive chemotherapy requiring protective isolation to contain the risk of life-threatening infection. Added to this care context is the breakdown of family ties as well as socio-professional ties, generating major anxiety and a risk of post-traumatic stress disorder (symptoms, which are common in acute myeloid leukemia. The hypothesis of our study is that hypnosis and virtual reality sessions combined with standard care could reduce anxiety and enhance chemotherapy treatment in acute myeloid leukemia patients when they first learn of their diagnosis.
Detailed description
Patients will be randomly assigned to one of the three arms. All patients will receive standard conventional chemotherapy treatments in accordance with international recommendations and standard conventional care (including supportive care) during their hospital stay. Depending on the group to which they are assigned, they will also participate in hypnotherapy or virtual reality sessions during their hospital stay. Patients will be asked to complete various self-administered questionnaires to measure their levels of anxiety, quality of life, and stress during the course of treatment, according to the study schedule
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hypnose | Experimental | Other: HypnosisPatients participate in six hypnosis sessions, each lasting 30 minutes, twice during the first and second weeks, then once a week for the following two weeks |
| Virtual Reality | Experimental | Other: Virtual RealityPatients participate in nine virtual reality sessions, each lasting 20 minutes, three times during the first week, then twice a week for the following three weeks |
| Control | No intervention | –Patients do not receive hypnosis sessions or virtual reality sessions |
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 over the age of 18
- Patient diagnosed with acute myeloid leukemia in Western Occitanie
- Eligible for first-line induction chemotherapy with anthracycline and cytarabine
- Patient able to understand and respond to a self-administered questionnaire
- Affiliated with or beneficiary of a social security system
Key exclusion criteria (7 listed)
- Patients diagnosed with acute myeloid leukemia 3
- Patients who were treated in intensive care prior to hospitalization for induction therapy or following induction therapy
- Patients with a diagnosed chronic pain-inducing disease (e.g., rheumatoid arthritis), if not stable
- Patients with a confirmed diagnosis of psychopathology such as psychosis, depression, or burnout, if not stable
- Patients suffering from epilepsy, whether treated or not, or with a history of epilepsy
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 |
|---|---|---|
| HypnosisEach session is based on the hypnosis techniques described by Erickson. In general, a session includes a hypnotic induction phase, a period of deepening and suggestions specific to the symptoms, followed by a return to reality. The hypnotherapist will be someone outside the team, trained in the Ericksonian method, who will intervene at a specific time during the sessions. | Other | Hypnose |
| Virtual RealityEach patient will be able to choose their environment from among those available (forest, beach, Zen garden, scuba diving, winter landscape, northern lights, astral travel, Antarctica, Maldives, desert), accompanied by ambient sounds. During the sessions, patients will be seated in their rooms at a quiet time outside of any treatment. | Other | Virtual Reality |
Primary outcome
Effect of an intervention combining standard care and virtual reality on the anxiety levels of patients at the end of induction chemotherapy for acute myeloid leukemia, compared to standard care and standard care with hypnosis
Time frame: 35 days
Change in anxiety score, measured using the Hospital Anxiety and Depression Scale
8 secondary outcomes
Effect of an intervention combining standard care and virtual reality, compared to standard care and standard care with hypnosis, on nociceptive pain
Time frame: 35 days
Evaluate the effect of an intervention combining standard care and virtual reality, compared to standard care and standard care with hypnosis, on anxiety
Time frame: 3 months
Evaluate the effect of an intervention combining standard care and virtual reality, compared to standard care and standard care with hypnosis, on quality of life
Time frame: 3 months
Evaluate the effect of an intervention combining standard care and virtual reality, compared to standard care and standard care with hypnosis, on post-traumatic stress disorder
Time frame: 3 months
Evaluate the effect of an intervention combining standard care and virtual reality, compared to standard care and standard care with hypnosis, on remission rate
Time frame: 35 days
Evaluate the effect of an intervention combining standard care and virtual reality, compared to standard care and standard care with hypnosis, on minimal residual disease
Time frame: 35 days
Evaluate the effect of an intervention combining standard care and virtual reality, compared to standard care and standard care with hypnosis, on consumption of analgesics and psychotropic drugs
Time frame: 35 days
Evaluate the effect of an intervention combining standard care and virtual reality, compared to standard care and standard care with hypnosis, on occurrence of adverse events related to induction treatment
Time frame: 35 days
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 4 Feb 2026.
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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.
Suzanne TAVITIAN, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypnosis and Virtual Reality in people with Acute Myeloid Leukemia, run by University Hospital, Toulouse 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 7 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 4 Feb 2026. 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?
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 Séverine SEAILLES (0531156360 ext. 33, seailles.severine@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of an intervention combining standard care and virtual reality on the anxiety levels of patients at the end of induction chemotherapy for acute myeloid leukemia, compared to standard care and standard care with hypnosis (time frame: 35 days). 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 4 Feb 2026.