Use of Virtual Reality Mask or Music Therapy for Analgesia and Anxiolytic Purpose When Totally IVAD for Chemotherapy Under Local Anesthesia
NCT ID: NCT04804735
Last Updated: 2025-07-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
127 participants
INTERVENTIONAL
2022-12-06
2023-08-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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REV : local anesthesia and virtual reality
Use of virtual reality device in Implanted Venous Access Device (IVAD) procedure under local anesthesia
REV : local anesthesia and virtual reality
REV : local anesthesia and virtual reality in Implanted Venous Access Device (IVAD) procedure under local anesthesia
MUS : local anesthesia and music therapy
Use of musicotherapy tool in Implanted Venous Access Device (IVAD) procedure under local anesthesia
MUS : local anesthesia and music therapy
MUS : local anesthesia and music therapy in Implanted Venous Access Device (IVAD) procedure under local anesthesia
CONTROL : standard local anesthesia
Implanted Venous Access Device (IVAD) procedure under local anesthesia as standard of care
No interventions assigned to this group
Interventions
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REV : local anesthesia and virtual reality
REV : local anesthesia and virtual reality in Implanted Venous Access Device (IVAD) procedure under local anesthesia
MUS : local anesthesia and music therapy
MUS : local anesthesia and music therapy in Implanted Venous Access Device (IVAD) procedure under local anesthesia
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
85 Years
ALL
No
Sponsors
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Institut Curie
OTHER
Responsible Party
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Principal Investigators
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Steven LE GOUILL, Pr.
Role: STUDY_DIRECTOR
Institut Curie
Locations
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Institut Curie
Paris, , France
Institut Curie
Saint-Cloud, , France
Gustave Roussy
Villejuif, , France
Countries
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Other Identifiers
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IC 2020-03
Identifier Type: -
Identifier Source: org_study_id
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