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

• Status: Completed
• Conditions: Preoperative Anxiety
• Intervention / Treatment: Other: Inclusion visit; Procedure: Coronarography on day 0; Other: Nurse consultation; Other: Telephone contact

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	Other: Inclusion visit; 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.; Procedure: Coronarography on day 0; 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	Other: Inclusion visit; 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.; Procedure: Coronarography on day 0; This coronarography is scheduled as part of the patient's routine care. This is not an experimental intervention under evaluation.; Other: Nurse consultation; 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.; Other: Telephone contact; 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)	Day 0 (within 1 hour preceding a coronography)

Secondary Outcome Measures

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

Collaborators and Investigators

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

Study record dates

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

• Keywords: Coronary Angiography
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• 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