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Completed

NCT Number: NCT05717296

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

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.

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Key information

Conditions

Vascular Diseases Cardiovascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Groupe hospitalier Paris Saint Joseph-hopital Marie Lannelongue

Le Plessis-Robinson, Île-de-France Region, 92350, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

anxiety survey

Other

surgery and anesthesia anxiety questionnaire

scale of satisfaction

Other

scale of satisfaction of multimedia

Multimedia Information

Other

Patients randomized to the "with multimedia support arm "will have access to educational videos focused on the vascular surgery they are to receive.

Primary outcomes

  1. 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

    Time frame: Day 0 ; Day 1 ; Day before the surgery

    The patient rates his anxiety between 0 and 10: 0 no anxiety; 10 maximum anxiety

Secondary outcomes

  1. Assessment of satisfaction with the multimedia support using a 4-point scale: 1) Very satisfied ; 2) Satisfied ; 3) Not very satisfied ; 4) Not satisfied

    Time frame: Day before the surgery

Sponsors and collaborators

Lead sponsor

Centre Chirurgical Marie Lannelongue

Other

Registry information

Official study title

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

Acronym: VASCUORG

Important dates

Study start
2022
Primary completion
2023
Study completion
2025
First posted
Feb 8, 2023
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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