Effect on preoperative anxiety of a personalized three-dimensional kidney model prior to nephron-sparing surgery for renal tumor: study protocol for a randomized controlled trial (Rein 3D Print-Anxiety - UroCCR 113).
<h4>Background</h4>The announcement of a diagnosis can be a source of anxiety for patients. Managing this anxiety is a major challenge, in terms of quality of life but also for the use of anxiolytic and analgesic therapies. The use of 3D modeling technology in partial nephrectomy surgery...
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Public Library of Science (PLoS)
2025-01-01
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| Online Access: | https://doi.org/10.1371/journal.pone.0321747 |
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| author | Alice Pitout Gaëlle Margue Joffrey Sarrazin Laura Richert Hugo Larribère Sarah Masanet Thibaut Waeckel Pierre Bigot Romain Boissier Bastien Parier Stéphane De Vergie Manon Jaffredo Solène Ricard Hélène Hoarau Marthe-Aline Jutand Matthieu Faessel Jocelyn Sabatier Jean-Christophe Bernhard |
| author_facet | Alice Pitout Gaëlle Margue Joffrey Sarrazin Laura Richert Hugo Larribère Sarah Masanet Thibaut Waeckel Pierre Bigot Romain Boissier Bastien Parier Stéphane De Vergie Manon Jaffredo Solène Ricard Hélène Hoarau Marthe-Aline Jutand Matthieu Faessel Jocelyn Sabatier Jean-Christophe Bernhard |
| author_sort | Alice Pitout |
| collection | DOAJ |
| description | <h4>Background</h4>The announcement of a diagnosis can be a source of anxiety for patients. Managing this anxiety is a major challenge, in terms of quality of life but also for the use of anxiolytic and analgesic therapies. The use of 3D modeling technology in partial nephrectomy surgery has proved its worth as a surgical aid but it could also help patients to manage their own care, by reducing their anxiety and increasing their understanding of the disease and its treatment. We aim to test this hypothesis with a prospective multicenter trial.<h4>Methods</h4>R3DP-A (Rein 3D - Anxiety) is an unblinded, multicenter, randomized, prospective, superiority-controlled trial. Participants are patients with kidney tumors treated by robot-assisted partial laparoscopic nephrectomy. The 234 patients (78x3 groups) from 6 French centers will undergo a pre-operative consultation dedicated to a personalized explanation of the surgical management and its risks. They will be randomized into three (1:1:1) groups corresponding to three types of support for consultation: use of a virtual 3D model of the kidney and its tumor; a printed 3D model; or the standard information sheet from the French Association of Urology (control group). Several self-questionnaires will be sent by the UroConnect® application and completed at different times during the study. The primary endpoint will be pre-operative anxiety (STAI-state questionnaire completed the day before surgery D-1). Secondary endpoints will be changes in anxiety levels between the pre-operative and post-operative consultations (between inclusion and D15 post-op), changes in health literacy and quality of life (HLSEU-Q16 and EQ-5D-5L questionnaires at inclusion and D15), feelings of understanding of the disease and its treatment at pre-operative period (Wake questionnaire at D-1), and consultation times.<h4>Discussion</h4>We aim to highlight a benefit of using a personalized 3D model on the anxiety level of patients undergoing partial nephrectomy surgery, as well as on their level of understanding of their pathology and its surgical treatment. The use of these models could be incorporated into current practice to improve patient experience throughout care. |
| format | Article |
| id | doaj-art-bb485c6082e64bcbbda1403b2b69bbe0 |
| institution | DOAJ |
| issn | 1932-6203 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
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| spelling | doaj-art-bb485c6082e64bcbbda1403b2b69bbe02025-08-20T03:05:50ZengPublic Library of Science (PLoS)PLoS ONE1932-62032025-01-01204e032174710.1371/journal.pone.0321747Effect on preoperative anxiety of a personalized three-dimensional kidney model prior to nephron-sparing surgery for renal tumor: study protocol for a randomized controlled trial (Rein 3D Print-Anxiety - UroCCR 113).Alice PitoutGaëlle MargueJoffrey SarrazinLaura RichertHugo LarribèreSarah MasanetThibaut WaeckelPierre BigotRomain BoissierBastien ParierStéphane De VergieManon JaffredoSolène RicardHélène HoarauMarthe-Aline JutandMatthieu FaesselJocelyn SabatierJean-Christophe Bernhard<h4>Background</h4>The announcement of a diagnosis can be a source of anxiety for patients. Managing this anxiety is a major challenge, in terms of quality of life but also for the use of anxiolytic and analgesic therapies. The use of 3D modeling technology in partial nephrectomy surgery has proved its worth as a surgical aid but it could also help patients to manage their own care, by reducing their anxiety and increasing their understanding of the disease and its treatment. We aim to test this hypothesis with a prospective multicenter trial.<h4>Methods</h4>R3DP-A (Rein 3D - Anxiety) is an unblinded, multicenter, randomized, prospective, superiority-controlled trial. Participants are patients with kidney tumors treated by robot-assisted partial laparoscopic nephrectomy. The 234 patients (78x3 groups) from 6 French centers will undergo a pre-operative consultation dedicated to a personalized explanation of the surgical management and its risks. They will be randomized into three (1:1:1) groups corresponding to three types of support for consultation: use of a virtual 3D model of the kidney and its tumor; a printed 3D model; or the standard information sheet from the French Association of Urology (control group). Several self-questionnaires will be sent by the UroConnect® application and completed at different times during the study. The primary endpoint will be pre-operative anxiety (STAI-state questionnaire completed the day before surgery D-1). Secondary endpoints will be changes in anxiety levels between the pre-operative and post-operative consultations (between inclusion and D15 post-op), changes in health literacy and quality of life (HLSEU-Q16 and EQ-5D-5L questionnaires at inclusion and D15), feelings of understanding of the disease and its treatment at pre-operative period (Wake questionnaire at D-1), and consultation times.<h4>Discussion</h4>We aim to highlight a benefit of using a personalized 3D model on the anxiety level of patients undergoing partial nephrectomy surgery, as well as on their level of understanding of their pathology and its surgical treatment. The use of these models could be incorporated into current practice to improve patient experience throughout care.https://doi.org/10.1371/journal.pone.0321747 |
| spellingShingle | Alice Pitout Gaëlle Margue Joffrey Sarrazin Laura Richert Hugo Larribère Sarah Masanet Thibaut Waeckel Pierre Bigot Romain Boissier Bastien Parier Stéphane De Vergie Manon Jaffredo Solène Ricard Hélène Hoarau Marthe-Aline Jutand Matthieu Faessel Jocelyn Sabatier Jean-Christophe Bernhard Effect on preoperative anxiety of a personalized three-dimensional kidney model prior to nephron-sparing surgery for renal tumor: study protocol for a randomized controlled trial (Rein 3D Print-Anxiety - UroCCR 113). PLoS ONE |
| title | Effect on preoperative anxiety of a personalized three-dimensional kidney model prior to nephron-sparing surgery for renal tumor: study protocol for a randomized controlled trial (Rein 3D Print-Anxiety - UroCCR 113). |
| title_full | Effect on preoperative anxiety of a personalized three-dimensional kidney model prior to nephron-sparing surgery for renal tumor: study protocol for a randomized controlled trial (Rein 3D Print-Anxiety - UroCCR 113). |
| title_fullStr | Effect on preoperative anxiety of a personalized three-dimensional kidney model prior to nephron-sparing surgery for renal tumor: study protocol for a randomized controlled trial (Rein 3D Print-Anxiety - UroCCR 113). |
| title_full_unstemmed | Effect on preoperative anxiety of a personalized three-dimensional kidney model prior to nephron-sparing surgery for renal tumor: study protocol for a randomized controlled trial (Rein 3D Print-Anxiety - UroCCR 113). |
| title_short | Effect on preoperative anxiety of a personalized three-dimensional kidney model prior to nephron-sparing surgery for renal tumor: study protocol for a randomized controlled trial (Rein 3D Print-Anxiety - UroCCR 113). |
| title_sort | effect on preoperative anxiety of a personalized three dimensional kidney model prior to nephron sparing surgery for renal tumor study protocol for a randomized controlled trial rein 3d print anxiety uroccr 113 |
| url | https://doi.org/10.1371/journal.pone.0321747 |
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