Effect of Hypnosis and Virtual Reality on Anxiety During Treatment for Acute Myeloid Leukemia (HYPNO-RV LAM)

Toulouse University Hospital

Status: Not yet enrolling

Conditions: Acute Myeloid Leukemia

Treatments: Other: Virtual Reality; Other: Hypnosis

Study type: Interventional

Funder types: Other

Identifiers

NCT07386392

RC31/22/0010

Details and patient eligibility

About

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.

Full 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

Enrollment: 99 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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 design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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99 participants in 3 patient groups

Hypnose

Experimental group

Description:

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

Treatment:

Other: Hypnosis

Virtual Reality

Experimental group

Description:

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

Treatment:

Other: Virtual Reality

Control

No Intervention group

Description:

Patients do not receive hypnosis sessions or virtual reality sessions