Study Protocol for the Development of an Intervention Integrating Procedures Combining Hypnosis and Virtual Reality in the Support of Patients with Myeloma and Lymphoma During Stem Cell Transplant: a Pilot Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Anxiety and depression
研究概览
简要总结
Research into cancer patients has shown that quality of life is significantly altered by the disease and its associated treatments and is also reported to be a predictor of significant emotional distress. Blood cancer patients are among those most affected in terms of quality of life, facing stem cell transplantation after high-dose chemotherapy, a treatment that is recognized as one of the most stressful of cancer therapy, due to the many adverse effects, including pain, and the uncertainty linked to the fear of graft failure. Hypnosis interventions are proving effective in treating common side effects: nausea, pain, fatigue, anxiety, depressive symptoms and improving overall quality of life, and other interventions, based on virtual reality, have shown promising effects on patients' distress and acute pain. The aim of this study is to evaluate the effects of an intervention program combining hypnosis and virtual reality in assisting myeloma and lymphoma patients during stem cell transplantation, with a view to improving their quality of life during this period. The project aims to assess the validity of the intervention, and to evaluate the effects of the intervention on patients' anxiety, pain and fatigue during transplantation. The validity of the intervention will be measured by a questionnaire assessing the relevance and acceptability of the intervention, expected effects, and practical implementation. Socio-demographic and clinical data will be collected from patients, including axiety, pain, fatigue and quality of life, studied at pre (one week after transplantation) and post (one month after transplantation) intervnention, and at follow-up (three month after transplantation).
详细描述
This proposal aims to reduce anxiety, pain and fatigue of transplant patients and thus improve their quality of life after the end of the intervention. To do this, the investigators will build on studies of VR use in oncology, and thus address the limitations of existing virtual reality (VR) programs, by developing an intervention that combines immersive technologies derived from VR with medical hypnosis (VRH). This new VRH program involves individualized patient management using hypnosis techniques, to promote better absorption into the experience and optimal response to hypnotic suggestions for managing emotions and pain. In concrete terms, this proposal has two complementary objectives:
- Evaluate the effects of an VRH prototype in reducing anxiety, pain and fatigue in transplant patients, and thus improving their quality of life after the intervention.
- Gather user experience, satisfaction levels and recommendations for improvement of the VRH prototype from patients
Methods
Intervention: An intervention program (VRH) that combines VR and hypnosis to facilitate the patient's absorption into a safe, benevolent imaginary world, in which they will be invited to live an experience that distracts them from their negative emotions and pain (Toujours Dimanche application).
The virtual experience will be structured along the lines of a hypnosis session: 1- A soothing immersion will first be offered to catalyze absorption through gentle descents and calming audio-visual stimuli, 2- Reaching a safe, relaxing space, dreamily representing two soothing natural environments (beach or park of the patient's choice), 3- Two therapeutic stress-management activities (dropping into a bag containing all the stress the participants want to get rid of, and allowing the participants to be carried by an imaginary horse, which enables them to escape to a safe place), 4- a physical discomfort manipulation activity enabling participants to remove the sensation of discomfort from the part of their body afflicted by it, and 5- Return to an awake state of consciousness.
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
- •Being 18 years of age or older
- •Suffering from multiple myeloma or lymphoma eligible for transplant
- •Understanding French
排除标准
- •Blindness
- •Confusion or psychopathological disorders (for example, schizophrenia) that may impair communication
结局指标
主要结局
Anxiety and depression
时间窗: Studied one week, one month and three months post-transplantation
Anxiety-depression will be measured using the Hospital anxiety and depression scale (HADS), a scale validated in French for cancer. This scale is made up of 14 items: 7 items determine the degree of anxiety and the other 7, the degree of depression. The score of each subscale is calculated by summing the score of each item, which varies between 0 and 3, so that each subscale can reach a maximum score of 21
Level of pain
时间窗: Studied one week, one month and three months post-transplantation
Pain will be assessed with the Brief Pain Inventory. This scale is made of 8 items on a 10-points Lickert scale (0=no pain, 10=worst pain) assessing severity of pain, impact of pain on daily function, location of pain, pain medications and amount of pain relief in the past 24 hours or the past week.
次要结局
- Level of quality of life(Studied one week, one month and three months post-transplantation)
- Absorption(Studied immediately before and after each use of the intervention 4 times during the two weeks in possession of the VR headset.)
- Dissociation(Studied immediately before and after each use of the intervention 4 times during the two weeks in possession of the VR headset.)
- Level of expectation and satisfaction(Measured respectively one week post-transplantation and three months post-transplantation)
- Level of pain(Studied immediately before and after each use of the intervention 4 times during the two weeks in possession of the VR headset.)
- Anxiety(Studied immediately before and after each use of the intervention 4 times during the two weeks in possession of the VR headset.)
- Relaxation(Studied immediately before and after each use of the intervention 4 times during the two weeks in possession of the VR headset.)
- Cybersickness(Measured after each use of the intervention 4 times during the two weeks in possession of the VR headset.)
- Amusement(Studied immediately before and after each use of the intervention 4 times during the two weeks in possession of the VR headset.)
- Fatigue(Studied immediately before and after each use of the intervention 4 times during the two weeks in possession of the VR headset.)