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

Vascular Diseases Clinical Trial

— VASCUORG  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05717296
• Other study ID #: 2022-A00664-39
• Status: Recruiting
• Phase: N/A
• Start date: June 29, 2022
• Est. completion date: February 28, 2024

Study information

• Verified date: September 2022
• Source: Centre Chirurgical Marie Lannelongue
• Contact: Stephan Haulon
• Phone: +33 (0) 4 40 94 28 00
• Email: s.haulon[@]ghpsj.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: February 28, 2024
• Est. primary completion date: June 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Vascular Diseases

Intervention

Other:
• anxiety survey
surgery and anesthesia anxiety questionnaire
• scale of satisfaction
scale of satisfaction of multimedia
• 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.

Locations

Country	Name	City	State
France	Groupe hospitalier Paris Saint Joseph-hopital Marie Lannelongue	Le Plessis-Robinson	Ile De France

Sponsors (1)

Lead Sponsor	Collaborator
Centre Chirurgical Marie Lannelongue

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Day 0 ; Day 1 ; Day before the surgery
Secondary	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