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Anti-Anxiety Agents

Patients having their kidney modelized in three dimensions on a software

Patients having their kidney modelized and printed in three dimensions

The day before surgery, all the patients will be visited by a member of the investigator team for preoperative consultation and will be given a questionnaire evaluating their anxiety based on STAI and VAS scores. The two experimental groups will be offered their renal modelization to be manipulated (virtually or physically) before the questionnaire.

A second survey assessing basic renal anatomy and surgery understanding will also be completed by the patients.

Anxiolytics prescription prior to surgery will be collected inside the medical file.

Anxiety, renal anatomy and surgery questionnaires

Investigators aimed to estimate the effect of showing and handling a three-dimensional modelization of a patient's kidney presenting with tumor the day before his nephron-sparing surgery. The main outcome measure was the effect on anxiety assessed via the STAI score. 2 types kidney models (virtual and printed) will be evaluated as compared to usual information, using a randomization.

Announcement of serious illnesses and especially cancerous diseases has major impacts on one's psychological field. Need of surgery can create even other fears due to its unknown nature. Use of tools to decrease anxiety and enhance understanding prior to surgery is a key point in comprehensive care that is way not enough promoted for now. In the field of surgery, available methods to deal with pre-operative anxiety are massively represented by anxiolytics drugs, only few other devices were evaluated.

Technological development in healthcare has seen the rising of three-dimensional media, especially in surgery, for procedure planning. There is no doubt that this tool is effective in helping surgeons regarding the studies published within the past few years but there is no such evidence concerning the benefit for patients. Some authors report improvement of patients understanding and great satisfaction referring to the usefulness of this tool. But none of these papers evaluated anxiety.

The goal of our research is to measure the effect of a personalized three-dimensional model of patients' kidney on pre-operative anxiety.

For this purpose investigators will randomly assign a total of 66 patients planned to have a nephron-sparing surgery for kidney tumor in 3 different groups. Inside the 2 interventional groups, patients' kidneys will be modelized in three dimensions, one group will then be 3D-printed.

The third group will be control with usual preoperative information. The day before surgery, 3D models will be presented to their respective owner. All patients will have to complete a survey evaluating their anxiety level and also their understanding of renal anatomy and surgical procedure.

Effect on Pre-operative Anxiety of a Personalized Three-dimensional Kidney Model Prior to Nephron-sparing Surgery for Renal Tumor.

Min : 20 = few anxiety Max : 80 = severe anxiety

Min : 0 = no anxiety Max : 10 = maximum anxiety

Renal anatomy : min/max = 0/13, higher values represent a better understanding Surgical strategies : min/max = 0/7, higher values represent a better understanding

Min : 0 = no pain Max : 10 = maximum pain

University Hospital, Bordeaux

Rare Diseases

Mental Disorders

Psychotic Disorders

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

exchange time with the virtual 3D model of the kidney to be operated on as information support

eexchange time with the printed three-dimensional model of the kidney to be operated on as information support

discussion time with the patient information sheet of the French Association of Urology (AFU) as information support

Before surgery, during a preoperative therapeutic education consultation, 3D models will be presented to the patients according to the allocated study group

3D model pré-operative education

Jean-Christophe BERNHARD, Professeur

Pierre BIGOT, Pr.

Jean-Christophe BERNHARD, Pr.

Thibaut WAECKEL, Dr.

Sébastien PARIER, Dr.

Romain BOISSIER, Pr.

Stéphane De VERGIE, Dr.

The goal of this clinical trial is to evaluate the impact of showing and handling a three-dimensional modelization of a patient's tumoral kidney the day before his nephron-sparing surgery. The main outcome measure was the effect on anxiety assessed via the STAI state score. 3 types of pre-operative information were compared (3D virtual model, 3D printed model, and information) using a randomization.

Announcement of serious illnesses and especially cancerous disease has major impacts on one's psychological field. Need of surgery can create even other fears due to its unknown nature. Use of tools to decrease anxiety and enhance understanding prior to surgery is a key point in comprehensive care that is way not enough promoted for now. In the field of surgery, available methods to deal with pre-operative anxiety are massively represented by anxiolytics drugs, only few other devices were evaluated.

Technological development in healthcare has seen the rising of three-dimensional media, especially in surgery, for procedure planning. There is no doubt that this tool is effective in helping surgeons regarding the studies published within the past few years but there is no such evidence concerning the benefit for patients. Some authors report improvement of patients understanding and great satisfaction referring to the usefulness of this tool. But none of these papers evaluated anxiety.

The goal of this research is to measure the effect of a personalized three-dimensional model of patients' tumoral kidney on peri-operative anxiety.

For this purpose this clinical trial is designed as following: a total of 234 (78\*3) patients planned to have a nephron-sparing surgery for kidney tumor are going to be randomly assign in 3 different groups. Inside the 2 interventional groups, patients' kidneys will be modelled in three dimensions, but in one of the two groups, the model will be 3D-printed. The control group will include patients for whom the pre-operative information will be made based on standardized information letter from the French Urological Association.

Before surgery, during a preoperative therapeutic education consultation, 3D models will be presented to the patients according to the allocated study group. All patients will have to complete questionnaires to assess their anxiety level, their quality of life, their health literacy level and their understanding of disease and surgical procedure.

One month after surgery, during the post-operative consultation, patients will also fill out the different questionnaires to assess their anxiety level, quality of life, and level of litteracy.

Effect on Pre-operative Anxiety of a Personalized Three-dimensional Kidney Model Prior to Nephron-sparing Surgery- Rein 3D Anxiety

Effect on Pre-operative Anxiety of a Personalized Three-dimensional Kidney Model Prior to Nephron-sparing Surgery for Renal Tumor. R3DP-A

The STAI-Etat will be collected before surgery to evaluate the effect of using a personalized three-dimensional model of the patient's kidney during a pre-operative information visit .

The progression of the mean anxiety score per arm, measured by STAI-State self-questionnaire at the three follow-up visits in the study and adjusted on the STAI-Trait score at baseline will assess feelings of apprehension, tension, nervousness and worries that the subject usually feels.

This questionnaire is a short version version of the European Health Literacy Survey Questionnaire based on a model including 4 health information processing skills: accessing, understanding, evaluating and applying application of health information .

The WAKE questionnaire is used assess the feeling of understanding of the disease and the choice of treatment preoperatively in each of the three groups, the questionnaire comprises five question on the understanding of the disease . Each dimension has 5 levels : very poor, poor,faire, good, very good or strongly desagree, disagree,neutral,agree or strongly agree

The EQ-5D-5L questionnaire measures participants' quality of life.The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Additinonally, the questionnaire records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effect on Pre-operative Anxiety of a Personalized Three-dimensional Kidney Model Prior to Nephron-sparing Surgery for Renal Tumor.	NCT03943771	Kidney Neoplasm... Carcinoma, Rena...	Anxiety, renal ...	18 Years -	University Hospital, Bordeaux
Effect on Pre-operative Anxiety of a Personalized Three-dimensional Kidney Model Prior to Nephron-sparing Surgery for Renal Tumor.	NCT03943771	Kidney Neoplasm... Carcinoma, Rena...	Anxiety, renal ...	18 Years -	University Hospital, Bordeaux
Effect on Pre-operative Anxiety of a Personalized Three-dimensional Kidney Model Prior to Nephron-sparing Surgery- Rein 3D Anxiety	NCT06035211	Tumoral Kidney	3D model pré-op...	18 Years -	University Hospital, Bordeaux

Spots Global Cancer Trial Database for 3d modeling

Every month we try and update this database with for 3d modeling cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for 3d modeling

Every month we try and update this database with for 3d modeling cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for 3d modeling cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.