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

NCT ID: NCT05717296

Last Updated: 2023-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-29

Study Completion Date

2024-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Vascular Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

with multimedia support

Group Type EXPERIMENTAL

anxiety survey

Intervention Type OTHER

surgery and anesthesia anxiety questionnaire

scale of satisfaction

Intervention Type OTHER

scale of satisfaction of multimedia

Multimedia Information

Intervention Type OTHER

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

without multimedia support

Group Type SHAM_COMPARATOR

anxiety survey

Intervention Type OTHER

surgery and anesthesia anxiety questionnaire

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

anxiety survey

surgery and anesthesia anxiety questionnaire

Intervention Type OTHER

scale of satisfaction

scale of satisfaction of multimedia

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre Chirurgical Marie Lannelongue

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Groupe hospitalier Paris Saint Joseph-hopital Marie Lannelongue

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

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Stephan Haulon

Role: CONTACT

+33 (0) 4 40 94 28 00

Florence Lecerf

Role: CONTACT

+33 (0) 1 40 94 25 17

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2022-A00664-39

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.