NCT07386392

Brief 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. 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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for not_applicable

Timeline
32mo left

Started Feb 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress9%
Feb 2026Dec 2028

First Submitted

Initial submission to the registry

January 26, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 4, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Expected
Last Updated

February 4, 2026

Status Verified

January 1, 2026

Enrollment Period

2 months

First QC Date

January 26, 2026

Last Update Submit

January 26, 2026

Conditions

Acute Myeloid Leukemia

Keywords

Acute Myeloid LeukemiaVirtual realityAnxietyChemotherapyPost-traumatic stressQuality of lifeSupportive care

Outcome Measures

Primary Outcomes (1)

  • 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

    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

    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

    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

    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

    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

    35 days

  • +3 more secondary outcomes

Study Arms (3)

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

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

Other: Virtual Reality

Control

NO INTERVENTION

Patients do not receive hypnosis sessions or virtual reality sessions

Interventions

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.

Hypnose
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.

Virtual Reality

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IUCT Oncopole

Toulouse, France, 31059, France

Location

MeSH Terms

Conditions

Leukemia, Myeloid, AcuteAnxiety Disorders

Interventions

Hypnosis

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Suzanne TAVITIAN, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Séverine SEAILLES

CONTACT

0531156360seailles.severine@chu-toulouse.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2026

First Posted

February 4, 2026

Study Start

February 1, 2026

Primary Completion

March 31, 2026

Study Completion (Estimated)

December 31, 2028

Last Updated

February 4, 2026

Record last verified: 2026-01

Locations

FR(1)