Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-24 @ 10:35 PM
NCT ID:
NCT04804735
Eligibility Criteria:
Inclusion Criteria:
1. Patient aged between 18 and 85 years.
2. Patient with cancer care and having a totally Implanted Venous Access Device (IVAD) procedure under local anesthesia for chemotherapy.
3. Absence of anxiolytic premedication.
4. Patient affiliated to social insurance.
5. Absence of contra-indication to the use of virtual reality, music therapy instrument or local lidocaine anesthesia.
6. Signed informed consent form.
Exclusion Criteria:
1. Patient already participated to this study.
2. Patient deprived of liberty or under legal representative or under curatorship.
3. Psychiatric disease enabling communication.
4. Deafness or visual impairement.
5. Patient under beta-blockers medication.
6. Chronic pain present and not equilibrated before the measured procedure as \> 3 by the NRS.
7. Tracheotomy.
8. Low cervical tumor, or bilateral low cervical adenopathies.
9. Compression or jugular stenosis (uni or bilateral).
10. Jugular or subclavian thrombosis.
11. Patient under anticoagulants medication or having hesmostasis troubles.
12. Claustrophobia or thalassophobia inducing the possibility of rejecting the virtual reality mask or music therapy mask.
13. Patients not speaking french.
14. Pregnant and breastfeeding women.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT04804735
Study Brief:
Protocol Section:
NCT04804735