Evaluation of the Effect of an Educational and Explanatory Program for a Surgical Act Provided to the Patient Prior to Said Act on Preoperative Anxiety - a Pilot Study at the Nîmes University Hospital on Elective Coronary Angiography

Centre Hospitalier Universitaire de Nīmes1 site in 1 country76 target enrollmentNovember 19, 2019

ConditionsPreoperative Anxiety

Overview

Phase: N/A
Intervention: Not specified
Conditions: Preoperative Anxiety
Sponsor: Centre Hospitalier Universitaire de Nīmes
Enrollment: 76
Locations: 1
Primary Endpoint: Amsterdam Preoperative Anxiety and Information Scale (APAIS)
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The main objective of this study is to evaluate the impact on preoperative anxiety of an education and information program conducted prior to non-urgent coronary angiography performed in patients hospitalized at the Nîmes University Hospital.

Detailed Description

The secondary objectives of this study are to assess the impact of the HEARTLINK program on the following parameters: A. Duration of hospital stay; B. Per operative blood and heart rate?; C. Patient satisfaction (visual analog scale).

Registry

clinicaltrials.gov

Start Date

November 19, 2019

End Date

May 10, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Centre Hospitalier Universitaire de Nīmes

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•The patient must have given his/her informed and signed consent
•The patient must be insured or beneficiary of a health insurance plan
•Patient for whom elective coronary angiography is indicated
•The patient has never had a coronary angiography before

Exclusion Criteria

•The patient is participating in another study
•The patient is in an exclusion period determined by a previous study
•The patient is under judicial protection, under tutorship or curatorship
•The patient refuses to sign the consent
•It is impossible to correctly inform the patient
•The patient is pregnant or breastfeeding
•The subject has already had a coronary angiography
•The subject has a cognitive impairment

Outcomes

Primary Outcomes

Amsterdam Preoperative Anxiety and Information Scale (APAIS)

Time Frame: Day 0 (within 1 hour preceding a coronography)

Secondary Outcomes

Cardiac frequency (beats per minute)(Day 0 (within 1 hour preceding a coronography))
Duration of hospitalization(Date hospital discharge (expected maximum of 5 days))
Visual analog scale for satisfaction concerning care(Day 0 (within 1 hour preceding a coronography))
Blood pressure(Day 0 (within 1 hour preceding a coronography))