Evaluation of the Effectiveness of a Multimedia Information Site in Reducing Preoperative Anxiety in Vascular Surgery Patients.

Study Overview
=================
Brief Summary
-----------------
Anxiety is a phenomenon that frequently occurs before surgery. Preoperative anxiety has been studied in several disciplines, including rheumatology, anesthesia, stomatology and cardiology. The implications of preoperative anxiety in terms of morbidity and mortality have also been studied and are well known: intraoperative hemodynamic disorders, increased postoperative mortality, increased consumption of anesthetic agents. Several scales have been developed to quantify preoperative anxiety, the most frequently used being the visual analog scale and the Amsterdam scale. Several approaches have been considered to reduce preoperative anxiety, such as hypnosis, music, or multimedia. However, no consensus tool has been developed for vascular surgery patients. Similarly, no study has examined preoperative anxiety in this specific population. The aim of this study is to evaluate a new multimedia information medium for vascular surgery patients and to assess its effectiveness in reducing preoperative anxiety.

Official Title
-----------------
Evaluation of the Effectiveness of a Multimedia Information Site in Reducing Preoperative Anxiety in Vascular Surgery Patients. A Controlled Trial

Conditions
-----------------
Vascular Diseases

Intervention / Treatment
-----------------
* Other: anxiety survey
* Other: scale of satisfaction
* Other: Multimedia Information


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient over 18 years of age Patient affiliated to a health insurance plan French-speaking patient Patient who has given free, informed and express consent Patient who has consulted a vascular surgeon for a scheduled procedure Patient with internet and telephone access to view videos Patient referred for surgical or endovascular treatment for obliterative arteriopathy of the lower limbs, abdominal aortic aneurysm and surgical treatment for carotid stenosis Exclusion Criteria: Patient under guardianship or curatorship Patient deprived of liberty Patient under court protection Patients with blindness Patients with severe cognitive impairment Patients without access to a digital support to view the videos Pregnant and breastfeeding women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: with multimedia support<br> | Other: anxiety survey<br>* surgery and anesthesia anxiety questionnaire<br>Other: scale of satisfaction<br>* scale of satisfaction of multimedia<br>Other: Multimedia Information<br>* Patients randomized to the with multimedia support arm will have access to educational videos focused on the vascular surgery they are to receive.<br>|
| Sham Comparator: without multimedia support<br> | Other: anxiety survey<br>* surgery and anesthesia anxiety questionnaire<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the evolution of preoperative anxiety in patients with access to multimedia with the help of a numerical scale compared to the group of patients without multimedia support | The patient rates his anxiety between 0 and 10: 0 no anxiety; 10 maximum anxiety | Day 0 ; Day 1 ; Day before the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of satisfaction with the multimedia support using a 4-point scale: 1) Very satisfied ; 2) Satisfied ; 3) Not very satisfied ; 4) Not satisfied |  | Day before the surgery |