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Clinical Trials/NCT05717296
NCT05717296
Completed
Not Applicable

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

Centre Chirurgical Marie Lannelongue2 sites in 1 country250 target enrollmentJune 29, 2022

Overview

Phase
Not Applicable
Intervention
anxiety survey
Conditions
Vascular Diseases
Sponsor
Centre Chirurgical Marie Lannelongue
Enrollment
250
Locations
2
Primary Endpoint
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
Status
Completed
Last Updated
yesterday

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.

Registry
clinicaltrials.gov
Start Date
June 29, 2022
End Date
December 31, 2025
Last Updated
yesterday
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Arms & Interventions

with multimedia support

Intervention: anxiety survey

with multimedia support

Intervention: scale of satisfaction

with multimedia support

Intervention: Multimedia Information

without multimedia support

Intervention: anxiety survey

Outcomes

Primary Outcomes

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

  • 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)

Study Sites (2)

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