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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| REV : local anesthesia and virtual reality | Experimental | Use of virtual reality device in Implanted Venous Access Device (IVAD) procedure under local anesthesia |
|
| MUS : local anesthesia and music therapy | Experimental | Use of musicotherapy tool in Implanted Venous Access Device (IVAD) procedure under local anesthesia |
|
| CONTROL : standard local anesthesia | No Intervention | Implanted Venous Access Device (IVAD) procedure under local anesthesia as standard of care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REV : local anesthesia and virtual reality | Device | REV : local anesthesia and virtual reality in Implanted Venous Access Device (IVAD) procedure under local anesthesia |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 day |
| Tolerance evaluated by NRS and responses to the closed questions (dizziness, nausea, suffocating feeling) completed at the end of the procedure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven LE GOUILL, Pr. | Institut Curie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Curie | Paris | 75005 | France | |||
| Institut Curie |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41794895 | Derived | Ghimouz A, Dureau S, Carton M, Gomola A, Fadel Z, Thuong KK, Muret J. The effects of music and virtual reality on pain and anxiety during central venous port implantation: a randomised clinical trial. Sci Rep. 2026 Mar 7;16(1):12514. doi: 10.1038/s41598-026-42184-w. |
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Sponsor will share de-identified data sets Documents generated under the project will be disseminated in accordance with Institut Curie policies.
Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).
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| MUS : local anesthesia and music therapy | Device | MUS : local anesthesia and music therapy in Implanted Venous Access Device (IVAD) procedure under local anesthesia |
|
NRS and responses to the closed questions |
| 1 day |
| Global patient satisfaction of NRS and comparison between the 3 groups. | patient satisfaction of NRS | 1 day |
| Pain NRS means felt during the procedure and comparison. | NRS means | 1 day |
| Anxiety NRS means felt during the procedure and comparison. | NRS means | 1 day |
| Saint-Cloud |
| 92210 |
| France |
| Gustave Roussy | Villejuif | 94805 | France |
| ID | Term |
|---|---|
| D009147 | Music Therapy |
| ID | Term |
|---|---|
| D026421 | Sensory Art Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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