Using virtual reality to manage pain during Port-a-Cath placement for cancer patients
Bliss DTx Assessment During Course Care Including Port-A-Catheter Setting
This study tests if using virtual reality can help cancer patients feel less pain and anxiety during the placement of a Port-a-Cath compared to traditional sedation methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 318 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Butterfly Therapeutics Industry-sponsored |
| Locations | 1 site (Angers) |
| Trial ID | NCT06495528 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of Bliss DTx, a digital therapeutic that utilizes virtual reality, in managing pain and anxiety during the placement of a Port-a-Cath in cancer patients. The procedure is typically performed under local anesthesia, with additional sedation options available. The study aims to determine if Bliss DTx can provide pain relief comparable to standard sedation methods, such as anxiolytics or inhalation of MEOPA. Participants will be monitored for pain levels and overall experience during the procedure.
Who should consider this trial
Good fit: Ideal candidates include adult cancer patients who require a Port-a-Cath placement and are able to provide informed consent.
Not a fit: Patients with previous Port-a-Cath placements, pain perception disorders, or contraindications to virtual reality will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a non-invasive and effective alternative for pain management during cancer treatment procedures.
How similar studies have performed: Previous studies using virtual reality for pain management have shown promising results, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Angers
- CHU Angers — Angers, France (Recruiting)
Study contacts
- Study coordinator: Katell Le Dû, MD
- Email: dr.ledu@groupeconfluent.fr
- Phone: +33 2 28 25 56 87
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.