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

Primary Purpose

Vascular Diseases

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
anxiety survey
scale of satisfaction
Multimedia Information
Sponsored by
Centre Chirurgical Marie Lannelongue
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Vascular Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Groupe hospitalier Paris Saint Joseph-hopital Marie LannelongueRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

with multimedia support

without multimedia support

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 20, 2022
Last Updated
February 3, 2023
Sponsor
Centre Chirurgical Marie Lannelongue
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1. Study Identification

Unique Protocol Identification Number
NCT05717296
Brief Title
Evaluation of the Effectiveness of a Multimedia Information Site in Reducing Preoperative Anxiety in Vascular Surgery Patients.
Acronym
VASCUORG
Official Title
Evaluation of the Effectiveness of a Multimedia Information Site in Reducing Preoperative Anxiety in Vascular Surgery Patients. A Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 29, 2022 (Actual)
Primary Completion Date
June 29, 2023 (Anticipated)
Study Completion Date
February 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Chirurgical Marie Lannelongue

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Diseases

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
with multimedia support
Arm Type
Experimental
Arm Title
without multimedia support
Arm Type
Sham Comparator
Intervention Type
Other
Intervention Name(s)
anxiety survey
Intervention Description
surgery and anesthesia anxiety questionnaire
Intervention Type
Other
Intervention Name(s)
scale of satisfaction
Intervention Description
scale of satisfaction of multimedia
Intervention Type
Other
Intervention Name(s)
Multimedia Information
Intervention Description
Patients randomized to the "with multimedia support arm "will have access to educational videos focused on the vascular surgery they are to receive.
Primary Outcome Measure Information:
Title
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
Description
The patient rates his anxiety between 0 and 10: 0 no anxiety; 10 maximum anxiety
Time Frame
Day 0 ; Day 1 ; Day before the surgery
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephan Haulon
Phone
+33 (0) 4 40 94 28 00
Email
s.haulon@ghpsj.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Florence Lecerf
Phone
+33 (0) 1 40 94 25 17
Email
f.lecerf@ghpsj.fr
Facility Information:
Facility Name
Groupe hospitalier Paris Saint Joseph-hopital Marie Lannelongue
City
Le Plessis-Robinson
State/Province
Ile De France
ZIP/Postal Code
92350
Country
France
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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