Evaluation of the Impact of the Use of Hypnotherapy Performed by a Virtual Reality Tool Along the Care Pathway of Patients Undergoing Breast Cancer Treatment: Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Evaluate, in patients undergoing chemotherapy for the treatment of breast cancer, the impact of the use of hypnotherapy performed by a virtual reality tool on the anxiety felt just before the PAC procedure.
研究概览
简要总结
In 2017, it is estimated that nearly 60,000 new cases of breast cancer will be diagnosed in France. Although several treatments are indicated in this context, chemotherapy remains a curability option whose place today extends to small tumors to support its increasingly approved administration contributing to a continuous increase in survival rates.
However, diagnostic procedures and anti-cancer treatments are frequently responsible for toxicity that can reach high levels of severity and even generate sequelae.
These physical and psychological after-effects of breast cancer treatment have a short and medium-term impact on the quality of life of the patients treated: anxiety, fear, pain, job loss, and the onset of precariousness.
In addition, surgical procedures such as PAC and pic-line surgery are often associated with anxiety and pain. Chemotherapy is particularly associated with anxiety, stress, fatigue, nausea and vomiting.
Some immediate, delayed or even anticipated side effects are not always effectively controlled by the medication available to us. Anti-nausea medications can lead to drug interactions and/or other adverse effects. The interest of a non-drug approach is to get rid of these adverse effects. However, it is underestimated and therefore currently not integrated into current practice.
Its benefits must therefore be explored within the framework of in-depth research protocols that justify our study.
详细描述
The use of virtual reality (VR) technology as a non-pharmacological tool has developed public interest in improving the control of certain adverse effects induced by chemotherapy. A few small studies suggest that the use of VR during chemotherapy helps reduce anxiety, fatigue and nausea and vomiting. Schneider showed improvement in stress-related symptoms such as anxiety in children aged 10 years and older receiving chemotherapy treatment during a VR session.
A similar study showed a reduction in anxiety in patients receiving chemotherapy for breast cancer treatment coupled with VR. Dr. Hoffman is recognized as a pioneer in the use of VR, which he has proven to be effective in the care of burn patients, coupled with a technique that some have called VR analgesia. He has demonstrated that this technology used in this setting is a novel non-pharmacological approach to improving pain control.
Our project involves the use of a VR module associated with an application delivering hypnotherapy combined with cognitive behavioral therapy that could help improve the adverse effects attributable to chemotherapy. The hypnotherapy that has been shown to be medically effective since its discovery by Mesmer is Ericksonian hypnosis. It usually involves an exchange between the therapist and the patient over a period of time.
marked (suggestion, induction, fascination, dissociation, amplification) which has evolved in our institution in a less elaborate form called "conversational hypnosis".
In this context, VR hypnotherapy appears to be a promising alternative. To date, there are a few studies that demonstrate the reduction of anxiety through the use of this tool during the application of PACs and pick-lines.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Woman whose age ≥ 18 years old
- •Negative pregnancy test for women of childbearing age
- •Francophone patient
- •Patient newly diagnosed with localized or metastatic breast cancer at the Paris Saint-Joseph Hospital Group (GhPSJ).
- •Patients in whom adjuvant or neoadjuvant chemotherapy treatment is planned
- •Patient affiliated to the social security system or, failing that, to another health insurance system
- •Patient who has given written consent.
排除标准
- •Psychotic patients (paranoia, schizophrenia and manic-depressive psychosis)
- •Patient suffering from pathological dissociations
- •Deaf and hard of hearing
- •Blind and severely visually impaired
- •Patient suffering from wounds or infections in the head area
- •Patient suffering from respiratory disorders
- •Patient with a high level of claustrophobia
- •Patient whose investigator determines that he or she cannot wear a virtual reality helmet
- •Patient under guardianship or curatorship
- •Patient deprived of liberty.
- •Pregnant or breastfeeding patient.
结局指标
主要结局
Evaluate, in patients undergoing chemotherapy for the treatment of breast cancer, the impact of the use of hypnotherapy performed by a virtual reality tool on the anxiety felt just before the PAC procedure.
时间窗: Day 7
Difference between the 2 groups of patients in terms of the anxiety felt just before the PAC procedure, evaluated by the Spielberger's State Anxiety Scale (STAI form Y-A). This scale evaluates the feelings of apprehension, tension, nervousness and anxiety that the subject feels at the time of the anxiety-provoking or competitive situation.
次要结局
- Evaluate in patients undergoing chemotherapy for the treatment of breast cancer the impact of the use of hypnotherapy using a virtual reality tool on the incidence of chemotherapy associated adverse events.(Day 7)
- Evaluate in patients undergoing chemotherapy for the treatment of breast cancer the impact of the use of hypnotherapy using a virtual reality tool on quality of life as measured by the QLC30 scale at the end of chemotherapy.(1 year)
- Evaluate the impact of the use of hypnotherapy on the immune system in patients undergoing chemotherapy for the treatment of breast cancer using a virtual reality tool.(Day 7 and 1 year)
- Evaluate in patients undergoing chemotherapy for the treatment of breast cancer the impact of the use of hypnotherapy performed by a virtual reality tool on the maximum pain and its duration felt by patients since the insertion of PAC.(Day 7)
- Evaluate in patients undergoing chemotherapy for the treatment of breast cancer the impact of the use of hypnotherapy using a virtual reality tool on the quality of life measured on the QBR23 scale at the end of chemotherapy.(1 year)