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

Not Applicable

Recruiting

• Conditions: Vascular Diseases
• Interventions: Other: anxiety survey; Other: scale of satisfaction; Other: Multimedia Information

• Registration Number: NCT05717296
• Lead Sponsor: Centre Chirurgical Marie Lannelongue

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-29
• Status Verified: 2022-09
• Study First Submitted: 2022-09-20
• Study First Submitted QC: 2023-02-03
• Last Update Submitted: 2023-02-03
• Study First Posted: 2023-02-08
• Last Update Posted: 2023-02-08
• Primary Completion: 2023-06-29
• Study Completion: 2024-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
with multimedia support	Multimedia Information	-
without multimedia support	anxiety survey	-
with multimedia support	scale of satisfaction	-
with multimedia support	anxiety survey	-

Primary Outcome Measures

Name	Time	Method
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	Day 0 ; Day 1 ; Day before the surgery	The patient rates his anxiety between 0 and 10: 0 no anxiety; 10 maximum anxiety

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Groupe hospitalier Paris Saint Joseph-hopital Marie Lannelongue; 🇫🇷 Le Plessis-Robinson, Ile De France, France