Actively Recruiting
Bliss DTx Assessment During Course Care Including Port-A-Catheter Setting
Led by Butterfly Therapeutics · Updated on 2024-07-10
318
Participants Needed
1
Research Sites
47 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Bliss DTx Assessment During Course Care Including Port-A-Catheter Setting
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient, male or female, aged 218 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
CHU Angers
Angers, France, 49933
Actively Recruiting
Research Team
K
Katell Le Dû, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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