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

Sponsor
Centre Chirurgical Marie Lannelongue (Other)
Overall Status
Recruiting
CT.gov ID
NCT05717296
Collaborator
(none)
250
1
2
20
12.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: anxiety survey
  • Other: scale of satisfaction
  • Other: Multimedia Information
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
250 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Evaluation of the Effectiveness of a Multimedia Information Site in Reducing Preoperative Anxiety in Vascular Surgery Patients. A Controlled Trial
Actual Study Start Date :
Jun 29, 2022
Anticipated Primary Completion Date :
Jun 29, 2023
Anticipated Study Completion Date :
Feb 28, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  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 [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

  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 [Day before the surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Groupe hospitalier Paris Saint Joseph-hopital Marie Lannelongue Le Plessis-Robinson Ile De France France 92350

Sponsors and Collaborators

  • Centre Chirurgical Marie Lannelongue

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Chirurgical Marie Lannelongue
ClinicalTrials.gov Identifier:
NCT05717296
Other Study ID Numbers:
  • 2022-A00664-39
First Posted:
Feb 8, 2023
Last Update Posted:
Feb 8, 2023
Last Verified:
Sep 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 8, 2023