Effect of Hypnosis and Virtual Reality on Anxiety During Treatment for Acute Myeloid Leukemia

Официальное название

Effect of Medical Hypnosis Compared to Virtual Reality or Standard Care on Anxiety During Induction Treatment for Acute Myeloid Leukemia

Обзор

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.

Подробное описание

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

Вмешательства

• Другое Hypnosis
  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.
• Другое Virtual Reality
  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.

Первичные конечные точки

• 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 [Срок оценки: 35 days]

Вторичные конечные точки (8)

• Effect of an intervention combining standard care and virtual reality, compared to standard care and standard care with hypnosis, on nociceptive pain [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 35 days]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Франция · 1 центр

• IUCT Oncopole — Toulouse

Идентификаторы

NCT: NCT07386392 · RC31/22/0010

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗