Status:
COMPLETED
Use of Virtual Reality Mask or Music Therapy for Analgesia and Anxiolytic Purpose When Totally IVAD for Chemotherapy Under Local Anesthesia
Lead Sponsor:
Institut Curie
Conditions:
Implanted Venous Access Device
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
Evaluate 2 medical devices on pain average and/or anxiety average in the totally Implanted Venous Access Device (IVAD) procedure under local anesthesia.
Detailed Description
Evaluate the efficacy of virtual reality and music therapy on pain average and/or anxiety average in the totally Implanted Venous Access Device (IVAD) procedure under local anesthesia.
Eligibility Criteria
Inclusion
- Patient aged between 18 and 85 years.
- Patient with cancer care and having a totally Implanted Venous Access Device (IVAD) procedure under local anesthesia for chemotherapy.
- Absence of anxiolytic premedication.
- Patient affiliated to social insurance.
- Absence of contra-indication to the use of virtual reality, music therapy instrument or local lidocaine anesthesia.
- Signed informed consent form.
Exclusion
- Patient already participated to this study.
- Patient deprived of liberty or under legal representative or under curatorship.
- Psychiatric disease enabling communication.
- Deafness or visual impairement.
- Patient under beta-blockers medication.
- Chronic pain present and not equilibrated before the measured procedure as \> 3 by the NRS.
- Tracheotomy.
- Low cervical tumor, or bilateral low cervical adenopathies.
- Compression or jugular stenosis (uni or bilateral).
- Jugular or subclavian thrombosis.
- Patient under anticoagulants medication or having hesmostasis troubles.
- Claustrophobia or thalassophobia inducing the possibility of rejecting the virtual reality mask or music therapy mask.
- Patients not speaking french.
- Pregnant and breastfeeding women.
Key Trial Info
Start Date :
December 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 16 2023
Estimated Enrollment :
127 Patients enrolled
Trial Details
Trial ID
NCT04804735
Start Date
December 6 2022
End Date
August 16 2023
Last Update
July 4 2025
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Institut Curie
Paris, France, 75005
2
Institut Curie
Saint-Cloud, France, 92210
3
Gustave Roussy
Villejuif, France, 94805