Effect of an Educational and Explanatory Program for a Surgical Act on Preoperative Anxiety (HEART-LINK)

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

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.

Study Overview

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).

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Nîmes Cedex 09, France, 30029
        • CHRU de Nîmes - Hôpital Universitaire Carémeau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Standard Care

Patients randomized to this arm will have standard care with no extra interventions.

Intervention: Inclusion visit

Intervention: Coronarography on day 0

This visit takes place between days -15 and -7 preceding a coronarography scheduled for Day 0. It is part of standard care and corresponds to a required cardiology consultation.
This coronarography is scheduled as part of the patient's routine care. This is not an experimental intervention under evaluation.
Experimental: HEARTLINK

Patients randomized to this arm will participate in the HEARTLINK program, which includes a specific nurse consultation and telephone contact.

Intervention: Inclusion visit

Intervention: Nurse consultation

Intervention: Telephone contact

Intervention: Coronarography on day 0

This visit takes place between days -15 and -7 preceding a coronarography scheduled for Day 0. It is part of standard care and corresponds to a required cardiology consultation.
This coronarography is scheduled as part of the patient's routine care. This is not an experimental intervention under evaluation.
This visit takes place on the same day as the inclusion visit and includes practical advice concerning the hospital stay, explanations concerning the surgical act and practical advice on its implementation, information on the length of stay and after. An explanatory booklet concerning the surgical procedure is provided to the patient.
A nurse will telephone the patient 72h to 48h before the coronarography scheduled for day 0. During the telephone conversation the nurse will assess the patient's knowledge about his/her pathology, his/her examination and the course of hospitalization. The nurse will answer any questions and if needed provide further information.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Amsterdam Preoperative Anxiety and Information Scale (APAIS)
Time Frame: Day 0 (within 1 hour preceding a coronography)
Day 0 (within 1 hour preceding a coronography)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Eric Baljou, IDE, Centre Hospitalier Universitaire de Nîmes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 19, 2019

Primary Completion (Actual)

May 10, 2022

Study Completion (Actual)

May 10, 2022

Study Registration Dates

First Submitted

April 7, 2016

First Submitted That Met QC Criteria

April 13, 2016

First Posted (Estimated)

April 18, 2016

Study Record Updates

Last Update Posted (Actual)

June 23, 2023

Last Update Submitted That Met QC Criteria

June 22, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LOCAL/2016/EB-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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