Use of Virtual Reality Mask or Music Therapy for Analgesia and Anxiolytic Purpose When Totally IVAD for Chemotherapy Under Local Anesthesia (REVCCI)

Institut Curie

Status: Active, not recruiting

Conditions: Implanted Venous Access Device

Treatments: Device: MUS : local anesthesia and music therapy; Device: REV : local anesthesia and virtual reality

Study type: Interventional

Funder types: Other

Identifiers

NCT04804735

IC 2020-03

Details and patient eligibility

About

Evaluate 2 medical devices on pain average and/or anxiety average in the totally Implanted Venous Access Device (IVAD) procedure under local anesthesia.

Full 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.

Enrollment: 127 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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127 participants in 3 patient groups

REV : local anesthesia and virtual reality

Experimental group

Description:

Use of virtual reality device in Implanted Venous Access Device (IVAD) procedure under local anesthesia

Treatment:

Device: REV : local anesthesia and virtual reality

MUS : local anesthesia and music therapy

Experimental group

Description:

Use of musicotherapy tool in Implanted Venous Access Device (IVAD) procedure under local anesthesia

Treatment:

Device: MUS : local anesthesia and music therapy

CONTROL : standard local anesthesia

No Intervention group

Description:

Implanted Venous Access Device (IVAD) procedure under local anesthesia as standard of care