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

Primary Purpose

Preoperative Anxiety

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Inclusion visit
Nurse consultation
Telephone contact
Coronarography on day 0
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Preoperative Anxiety focused on measuring Coronary Angiography

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHRU de Nîmes - Hôpital Universitaire Carémeau

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Standard Care

HEARTLINK

Arm Description

Patients randomized to this arm will have standard care with no extra interventions. Intervention: Inclusion visit Intervention: Coronarography on day 0

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

Outcomes

Primary Outcome Measures

Amsterdam Preoperative Anxiety and Information Scale (APAIS)

Secondary Outcome Measures

Duration of hospitalization
Blood pressure
Cardiac frequency (beats per minute)
Visual analog scale for satisfaction concerning care

Full Information

First Posted
April 7, 2016
Last Updated
June 22, 2023
Sponsor
Centre Hospitalier Universitaire de Nīmes
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1. Study Identification

Unique Protocol Identification Number
NCT02742025
Brief Title
Effect of an Educational and Explanatory Program for a Surgical Act on Preoperative Anxiety
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
November 19, 2019 (Actual)
Primary Completion Date
May 10, 2022 (Actual)
Study Completion Date
May 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preoperative Anxiety
Keywords
Coronary Angiography

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Care
Arm Type
Other
Arm Description
Patients randomized to this arm will have standard care with no extra interventions. Intervention: Inclusion visit Intervention: Coronarography on day 0
Arm Title
HEARTLINK
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Inclusion visit
Intervention Description
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
Intervention Name(s)
Nurse consultation
Intervention Description
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
Intervention Name(s)
Telephone contact
Intervention Description
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
Procedure
Intervention Name(s)
Coronarography on day 0
Intervention Description
This coronarography is scheduled as part of the patient's routine care. This is not an experimental intervention under evaluation.
Primary Outcome Measure Information:
Title
Amsterdam Preoperative Anxiety and Information Scale (APAIS)
Time Frame
Day 0 (within 1 hour preceding a coronography)
Secondary Outcome Measure Information:
Title
Duration of hospitalization
Time Frame
Date hospital discharge (expected maximum of 5 days)
Title
Blood pressure
Time Frame
Day 0 (within 1 hour preceding a coronography)
Title
Cardiac frequency (beats per minute)
Time Frame
Day 0 (within 1 hour preceding a coronography)
Title
Visual analog scale for satisfaction concerning care
Time Frame
Day 0 (within 1 hour preceding a coronography)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Baljou, IDE
Organizational Affiliation
Centre Hospitalier Universitaire de Nîmes
Official's Role
Study Director
Facility Information:
Facility Name
CHRU de Nîmes - Hôpital Universitaire Carémeau
City
Nîmes Cedex 09
ZIP/Postal Code
30029
Country
France

12. IPD Sharing Statement

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

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