Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
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.
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:
NCT07386392
Study Brief:
Protocol Section:
NCT07386392