Evaluate 2 medical devices on pain average and/or anxiety average in the totally Implanted Venous Access Device (IVAD) procedure under local anesthesia.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
127
REV : local anesthesia and virtual reality in Implanted Venous Access Device (IVAD) procedure under local anesthesia
MUS : local anesthesia and music therapy in Implanted Venous Access Device (IVAD) procedure under local anesthesia
Institut Curie
Paris, France
Institut Curie
Saint-Cloud, France
Gustave Roussy
Villejuif, France
mean of pain felt during the whole IVAD procedure
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.
Time frame: 1 day
mean of anxiety felt during the whole IVAD procedure
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.
Time frame: 1 day
Correlation coefficient between the ANI air under the curve and the pain measure with the numerical rating scale.
Correlation coefficient between the ANI air under the curve and the pain measure with the numerical rating scale.
Time frame: 1 day
Tolerance evaluated by NRS and responses to the closed questions (dizziness, nausea, suffocating feeling) completed at the end of the procedure.
NRS and responses to the closed questions
Time frame: 1 day
Global patient satisfaction of NRS and comparison between the 3 groups.
patient satisfaction of NRS
Time frame: 1 day
Pain NRS means felt during the procedure and comparison.
NRS means
Time frame: 1 day
Anxiety NRS means felt during the procedure and comparison.
NRS means
Time frame: 1 day
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