Implanted Venous Access Device
Conditions
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.
Interventions
DEVICEREV : local anesthesia and virtual reality
REV : local anesthesia and virtual reality in Implanted Venous Access Device (IVAD) procedure under local anesthesia
DEVICEMUS : local anesthesia and music therapy
MUS : local anesthesia and music therapy in Implanted Venous Access Device (IVAD) procedure under local anesthesia
Sponsors
Institut Curie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| mean of pain felt during the whole IVAD procedure | 1 day | 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. |
| mean of anxiety felt during the whole IVAD procedure | 1 day | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Global patient satisfaction of NRS and comparison between the 3 groups. | 1 day | patient satisfaction of NRS |
| Correlation coefficient between the ANI air under the curve and the pain measure with the numerical rating scale. | 1 day | Correlation coefficient between the ANI air under the curve and the pain measure with the numerical rating scale. |
| Anxiety NRS means felt during the procedure and comparison. | 1 day | NRS means |
| Pain NRS means felt during the procedure and comparison. | 1 day | NRS means |
| Tolerance evaluated by NRS and responses to the closed questions (dizziness, nausea, suffocating feeling) completed at the end of the procedure. | 1 day | NRS and responses to the closed questions |
Countries
France
Outcome results
None listed