Effect of Medical Hypnosis Compared to Virtual Reality or Standard Care on Anxiety During Induction Treatment for Acute Myeloid Leukemia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Hypnose
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
干预措施: Hypnosis (Other)
Virtual Reality
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
干预措施: Virtual Reality (Other)
Control
Patients do not receive hypnosis sessions or virtual reality sessions
结局指标
主要结局
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
时间窗: 35 days
Change in anxiety score, measured using the Hospital Anxiety and Depression Scale
次要结局
- 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)
- 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(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(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(35 days)