CompletedNot Applicable

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

France127 participantsStarted 2022-12-06

Plain-language summary

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

Who can participate

Age range18 Years – 85 Years

SexALL

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Inclusion criteria

✓. Patient aged between 18 and 85 years.
✓. Patient with cancer care and having a totally Implanted Venous Access Device (IVAD) procedure under local anesthesia for chemotherapy.
✓. Absence of anxiolytic premedication.
✓. Patient affiliated to social insurance.
✓. Absence of contra-indication to the use of virtual reality, music therapy instrument or local lidocaine anesthesia.
✓. Signed informed consent form.

Exclusion criteria

✕. Patient already participated to this study.
✕. Patient deprived of liberty or under legal representative or under curatorship.
✕. Psychiatric disease enabling communication.
✕. Deafness or visual impairement.
✕. Patient under beta-blockers medication.
✕. Chronic pain present and not equilibrated before the measured procedure as \> 3 by the NRS.
✕. Tracheotomy.
✕. Low cervical tumor, or bilateral low cervical adenopathies.

What they're measuring

mean of pain felt during the whole IVAD procedure

Timeframe: 1 day

mean of anxiety felt during the whole IVAD procedure

Timeframe: 1 day

Trial details

NCT IDNCT04804735

SponsorInstitut Curie

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-08-16

View on ClinicalTrials.gov More Implanted Venous Access Device trials