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

Centre Chirurgical Marie Lannelongue

Status: Enrolling

Conditions: Vascular Diseases

Treatments: Other: Multimedia Information; Other: anxiety survey; Other: scale of satisfaction

Study type: Interventional

Funder types: Other

Identifiers

NCT05717296

2022-A00664-39

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

with multimedia support

Experimental group

Treatment:

Other: Multimedia Information

Other: anxiety survey

Other: scale of satisfaction

without multimedia support

Sham Comparator group

Treatment:

Other: anxiety survey