Clinical trial NCT04804735: Use of Virtual Reality Mask or Music Therapy for Analgesia and Anxiolytic Purpose When Totally IVAD for Chemotherapy Under Local Anesthesia
Official 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Implanted Venous Access Device
Lead sponsor: Institut Curie
Sponsor class: OTHER
First posted: 2021-03-18
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 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.

Primary outcomes:
measure: mean of pain felt during the whole IVAD procedure
timeFrame: 1 day
measure: mean of anxiety felt during the whole IVAD procedure
timeFrame: 1 day
Secondary outcomes:
measure: Correlation coefficient between the ANI air under the curve and the pain measure with the numerical rating scale.
timeFrame: 1 day
measure: Tolerance evaluated by NRS and responses to the closed questions (dizziness, nausea, suffocating feeling) completed at the end of the procedure.
timeFrame: 1 day
measure: Global patient satisfaction of NRS and comparison between the 3 groups.
timeFrame: 1 day
measure: Pain NRS means felt during the procedure and comparison.
timeFrame: 1 day
measure: Anxiety NRS means felt during the procedure and comparison.
timeFrame: 1 day
Other outcomes:
Locations:
city: Paris
country: France
facility: Institut Curie
city: Saint-cloud
country: France
facility: Institut Curie
city: Villejuif
country: France
facility: Gustave Roussy
Study officials:
affiliation: Institut Curie
name: Steven LE GOUILL, Pr.
role: STUDY_DIRECTOR
References: