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

NCT ID: NCT02742025

Last Updated: 2023-06-23

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-19

Study Completion Date

2022-05-10

Brief Summary

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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

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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).

Conditions

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Preoperative Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Standard Care

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

Intervention: Inclusion visit

Intervention: Coronarography on day 0

Group Type OTHER

Inclusion visit

Intervention Type OTHER

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.

Coronarography on day 0

Intervention Type PROCEDURE

This coronarography is scheduled as part of the patient's routine care. This is not an experimental intervention under evaluation.

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

Group Type EXPERIMENTAL

Inclusion visit

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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.

Coronarography on day 0

Intervention Type PROCEDURE

This coronarography is scheduled as part of the patient's routine care. This is not an experimental intervention under evaluation.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Coronarography on day 0

This coronarography is scheduled as part of the patient's routine care. This is not an experimental intervention under evaluation.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eric Baljou, IDE

Role: STUDY_DIRECTOR

Centre Hospitalier Universitaire de Nîmes

Locations

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CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, , France

Site Status

Countries

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France

Other Identifiers

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LOCAL/2016/EB-01

Identifier Type: -

Identifier Source: org_study_id

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