Implanted Venous Access Device Clinical Trial
— REVCCIOfficial title:
Use of Virtual Reality Mask or Music Therapy for Analgesia and Anxiolytic Purpose When Totally Implanted Venous Access Device (IVAD) for Chemotherapy Under Local Anesthesia
| Verified date | September 2023 |
| Source | Institut Curie |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Evaluate 2 medical devices on pain average and/or anxiety average in the totally Implanted Venous Access Device (IVAD) procedure under local anesthesia.
| Status | Active, not recruiting |
| Enrollment | 127 |
| Est. completion date | March 16, 2024 |
| Est. primary completion date | August 16, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 85 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| France | Institut Curie | Paris | |
| France | Institut Curie | Saint-cloud | |
| France | Gustave Roussy | Villejuif |
| Lead Sponsor | Collaborator |
|---|---|
| Institut Curie |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | mean of pain felt during the whole IVAD procedure | pain means will be measured with the Numerical Rating Scale (NRS) from 0 to 10 with 0 corresponding to no pain and 10 the maximum pain feeling. | 1 day | |
| Primary | mean of anxiety felt during the whole IVAD procedure | Anxiety means will be measured with the Numerical Rating Scale (NRS) from 0 to 10 with 0 corresponding to no anxiety and 10 the maximum anxiety feeling. | 1 day | |
| Secondary | Correlation coefficient between the ANI air under the curve and the pain measure with the numerical rating scale. | Correlation coefficient between the ANI air under the curve and the pain measure with the numerical rating scale. | 1 day | |
| Secondary | Tolerance evaluated by NRS and responses to the closed questions (dizziness, nausea, suffocating feeling) completed at the end of the procedure. | NRS and responses to the closed questions | 1 day | |
| Secondary | Global patient satisfaction of NRS and comparison between the 3 groups. | patient satisfaction of NRS | 1 day | |
| Secondary | Pain NRS means felt during the procedure and comparison. | NRS means | 1 day | |
| Secondary | Anxiety NRS means felt during the procedure and comparison. | NRS means | 1 day |