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

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

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.

Study Overview

• Status: Completed
• Conditions: Vascular Diseases
• Intervention / Treatment: Other: anxiety survey; Other: scale of satisfaction; Other: Multimedia Information

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Île-de-France Region
    • Le Plessis-Robinson, Île-de-France Region, France, 92350
      • Groupe hospitalier Paris Saint Joseph-hopital Marie Lannelongue

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

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	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

Collaborators and Investigators

• Sponsor: Centre Chirurgical Marie Lannelongue

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2022
• Primary Completion (Actual): June 29, 2023
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: September 20, 2022
• First Submitted That Met QC Criteria: February 3, 2023
• First Posted (Actual): February 8, 2023

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases
• Other Study ID Numbers: 2022-A00664-39

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No