Therapeutic Virtual Reality : Impact on the Management of Pain and Anxiety Related to Hematology Care
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 126
- 试验地点
- 5
- 主要终点
- Assessment of pain
研究概览
简要总结
The management of hematological malignancies justifies the completion of a complete assessment before the start of treatment. This assessment includes imaging tests (computed tomography, position emission tomography, cavitary scintigraphy), biology and very often an exploration of the bone marrow by anterior or posterior iliac biopsy. Pains related to the disease (node compression, invasion of solid organs) are taken care of at the diagnosis and often relieved by the start of the specific treatment.
However, pain related to medical procedure is often overlooked and can lead to psychological trauma in some patients who may refuse to repeat these essential actions to assess the response to treatment.
Anxiety contributes to pain and various relaxation techniques have already proven their effectiveness. The goal of the protocol is to reduce the pain and anxiety associated with medical procedure by using virtual reality with a helmet proposed at the time of the gesture.
详细描述
Today, one third of the population suffers from anxiety and 20% of French people suffer from chronic pain. Many health situations or pathologies lead to difficult or painful care. The impact of drug solutions to relieve patients is often limited and more and more scientific studies are demonstrating the benefits of virtual reality to reduce pain, anxiety and addictions.
In 2011, following an experience of close to patient, a person created "l'Effet Papillon", a social enterprise that aims to create a concrete social impact in the lives of people with cancer, in situations of fragility or isolation and those who accompany them. Since 2011 the social enterprise has supported nearly 3,000 patients and today, the Butterfly Effect is a real partner of health actors by adopting a holistic approach to wellness in the face of disease and fragility.
Taking full advantage of the benefits of virtual reality that, used in medical settings, can reduce pain and anxiety, Bliss is a 3D Interactive application designed to meet the needs of escape and relaxation of people in isolation and / or or stress.
Bliss has been developed for and with patients in partnership with physicians, researchers and experts in virtual reality for therapeutic purposes.
Bliss offer a new tool for relaxation and well-being that relaxes and distracts users from moments of stress or anxiety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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 with malignant haematological pathology
- •Patient who must have an osteo-medullary biopsy for diagnostic purposes
- •Age ≥ 18 years
- •Performance Status < 3
- •Patient with no pelvic bone pain before inclusion
- •Patient with normal coagulation balance (TP, Activated Partial Thromboplastin Time, fibrin) and platelet count> 50 G / L
- •Patient affiliated to the social security scheme
- •Patient giving written consent before any specific procedure related to the study
排除标准
- •Patient regularly taking antalgic treatments from stage 2 or 3
- •Patient with congenital coagulation disorder or acquired or taking anticoagulant therapy such as: fluindione, acenocoumarol, warfarin, dabigatran, apixaban or rivaroxaban
- •Contraindication to a gas mixture composed of 50% Nitrous Oxide, 50% Oxygen administration: true allergy, severe respiratory failure requiring continuous oxygen therapy, emphysema, pneumothorax, history of air embolism or diving accident, epilepsy or uncontrolled neurological disorder, unsubstituted vitamin deficiency B12 and folic acid, abdominal gas distension
- •Any contraindication to the use of the headset: pacemaker or other implanted medical device
- •Pregnancy or breastfeeding
- •Persons deprived of liberty, under guardianship or under guardianship
- •Dementia, mental impairment or psychiatric condition that may compromise patient informed consent and / or protocol compliance and follow-up of the trial
- •Patient unable to undergo protocol monitoring for psychological, social, family or geographical reasons
研究组 & 干预措施
Kalinox®
The included patients in this group will have, during the intervention, a local anesthesia by xylocaine® 10 mg / mL (1 bottle of 20 mL) in complement of a gas mixture composed of 50% Nitrous Oxide, 50% Oxygen (Kalinox®)
干预措施: Kalinox (Drug)
Virtual Reality
The included patients in this group will have, during the intervention, a local anesthesia by xylocaine® 10 mg / mL (1 bottle of 20 mL) in complement of a virtual reality (VR) session.
干预措施: Virtual Reality (Device)
结局指标
主要结局
Assessment of pain
时间窗: Fifteen minutes after the osteo-medullary biopsy
Pain will be evaluated by Visual Analog Scale (0 = no pain at 10 = worst possible pain).
次要结局
- Assessment of the fear of pain by questionnaire(Assessment at Baseline)
- Assessment of the fear of pain by Visual Analog Scale(Assessment at Baseline)
- Assessment of residual pain(One month after the osteo-medullary biopsy)
- Assessment of investigator's satisfaction(Fifteen minutes after the osteo-medullary biopsy)
- Assessment of drug consumption related to the osteo-medullary biopsy (Xylocaine)(During the osteo-medullary biopsy)
- Assessment of patient's satisfaction(Fifteen minutes after the osteo-medullary biopsy)
- Assessment of nurse's satisfaction(Fifteen minutes after the osteo-medullary biopsy)
- Assessment of drug consumption related to the osteo-medullary biopsy (Kalinox)(During the osteo-medullary biopsy)
- Assessment of tolerance(During or within fifteen minutes after the osteo-medullary biopsy)
- Assessment of the anxiety by specific questionnaire(Fifteen minutes after the osteo-medullary biopsy)
- Assessment of the anxiety by blood pressure measurement(Fifteen minutes after the osteo-medullary biopsy)