Effect on Pre-operative Anxiety of a Personalized Three-dimensional Kidney Model Prior to Nephron-sparing Surgery- Rein 3D Anxiety
Recruiting · NCT06035211 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
3D model pré-operative education
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Adult patients (≥ 18 years of age)
- Scheduled surgical management by laparoscopic partial nephrectomy with robotic assistance for kidney tumor
- Unilateral kidney tumor or 1st surgery for bilateral involvement
- Consent expressed for integration of the UroCCR cohort,
- Expressed consent for participation in the 3D Anxiety study.
- Patients affiliated or benefiting from a social security plan
Exclusion criteria
- Refusal of consent or participation
- Difficulty understanding and expressing oneself in French
- Patient under guardianship or curatorship
- No preoperative CT scan available for 3D modeling
Where it is running
6 locations listed.
- CHU d'ANGERS - Angers, France
- CHU de Bordeaux - Bordeaux, France
- CHU de CAEN - Caen, France
- Hôpital Kremlin-Bicêtre - Le Kremlin-Bicêtre, France
- CHU de La CONCEPTION - Marseille, France
- CHU de NANTES - Nantes, France