Effect of an Educational and Explanatory Program for a Surgical Act on Preoperative Anxiety

Preoperative Anxiety Clinical Trial

— HEART-LINK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02742025
• Other study ID #: LOCAL/2016/EB-01
• Status: Completed
• Phase: N/A
• Start date: November 19, 2019
• Est. completion date: May 10, 2022

Study information

• Verified date: June 2023
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: May 10, 2022
• Est. primary completion date: May 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Preoperative Anxiety

Intervention

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.
• 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.
• 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.

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.

Locations

Country	Name	City	State
France	CHRU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amsterdam Preoperative Anxiety and Information Scale (APAIS)		Day 0 (within 1 hour preceding a coronography)
Secondary	Duration of hospitalization		Date hospital discharge (expected maximum of 5 days)
Secondary	Blood pressure		Day 0 (within 1 hour preceding a coronography)
Secondary	Cardiac frequency (beats per minute)		Day 0 (within 1 hour preceding a coronography)
Secondary	Visual analog scale for satisfaction concerning care		Day 0 (within 1 hour preceding a coronography)