Bliss DTx Assessment During Course Care Including Port-A-Catheter Setting
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 318
- 试验地点
- 2
- 主要终点
- Pain level
研究概览
简要总结
Setting a Port-a Cath is performed in a surgical room, under ambulatory, by a specialist, under local anesthesia. This Port-a Cath is placed in the upper part of the thorax, under the clavicle, and facilitate the administration of certain anticancer drugs or to inject other treatments throughout the course of care.
Setting a Port-a Cath is painful and stressful. In addition to local anesthesia, patients are often offered a sedation: anxiolytics, hypnotics or inhalation of MEOPA.
Butterfly Therapeutics has developed a Digital Therapeutics (DTx) called Bliss DTx which uses virtual reality augmented by sound and visual stimuli. A first clinical study with Bliss DTx showed that the pain level was not significantly different between "Bliss DTx" arm and "MEOPA" arm when performing osteomedullary biopsy.
This study is based on the hypothesis that Bliss DTx use would :
- Be clinically equivalent to a standard protocol (use of hypnotics and/or anxiolytics and/or MEOPA and/or hypnosis conversational) to manage pain during Port-a Cath setting under local anesthesia
- Reduce anxiety before setting a Port-a Cath
- Provide greater satisfaction with the treatment process from patient point of view
- Have organizational impacts, some of which could be economically valued
详细描述
An implantable catheter port, also called Port-a Cath, is placed in the upper part of the thorax under the clavicle. Setting is performed in a surgical room, under ambulatory, by a specialist, under local anesthesia. This Port-a Cath is set up to facilitate the administration of certain anticancer drugs or to inject other treatments throughout the course of care.
Setting a Port-a Cath is painful and stressful. In addition to local anesthesia, patients are often offered a sedation: anxiolytics as premedication, hypnotics before or during the Port-a Cath setting, inhalation of MEOPA (equimolar mixture of oxygen and nitrogen protoxide, medicinal anxiolytic and analgesic gas , colorless and slightly odorous, mainly used in a hospital environment).
Virtual reality technology allows a person to be immersed in a virtual environment using a device consisting of headset audio and 3D display system. This is a non-invasive device that has an effect on the anxiety and pain level of patients. Butterfly Therapeutics has developed a Digital Therapeutics (DTx) called Bliss DTx which uses virtual reality augmented by sound and visual stimuli. A first clinical study with Bliss DTx which was released in 2021 showed that the pain level was not significantly different between "Bliss DTx" arm and "MEOPA" arm when performing osteomedullary biopsy.
Bliss DTx is also used in everyday practice by many doctors, surgeons, anesthetists and nurses, who do not observe significant pain difference between Bliss DTx and chemical sedations during the acts, but note interesting differences from an organizational point of view between the different methods.
A new evolution of Bliss DTx offers features that allow to increase winnings throughout the course including installation of a Port-a Cath.
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, male or female, aged ≥ 18 years
- •Patient with a cancer diagnosis
- •Patient with Port-A-Cath setting under ambulatory
- •Patient affiliated to or beneficiary of a social security system
- •French speaking patient having signed informed consent
排除标准
- •Patient with previous Port-A-Cath setting
- •Patient with pain perception disorder
- •Patient with contraindication to the use of virtual reality (VR) and screens
- •Pregnant woman
- •Protected patient
结局指标
主要结局
Pain level
时间窗: 1 day
Maximum pain level during Port-A-Cath setting will be assessed using Visual Analog Scale : from 0 (no pain) to 10 (intolerable)
Patient anxiety
时间窗: 1 day
Patient anxiety before Port-A-Cath setting will be assessed with Hamilton score. Score 10 to 13: mild depressive symptoms. Score 14 to 17: mild to moderate depressive symptoms. Score greater than 18: moderate to severe depressive
Patient satisfaction
时间窗: 1 day
The overall experience score and patient satisfaction will be assessed using the e-Satis questionnaire in ambulatory surgery (MCO CA) at the end of the treatment course. This a specific french questionnaire without global final score. There are only questions with following rating : poor, weak, medium, good, excellent
次要结局
未报告次要终点