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

Sponsor
Centre Hospitalier Universitaire de Nīmes (Other)
Overall Status
Recruiting
CT.gov ID
NCT02742025
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
38.4
Anticipated Duration (Months)
2.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Inclusion visit
  • Other: Nurse consultation
  • Other: Telephone contact
  • Procedure: Coronarography on day 0
 N/A

Detailed Description

The secondary objectives of this study are to assess the impact of the HEARTLINK program on the following parameters:

  1. Duration of hospital stay; B. Per operative blood and heart rate?; C. Patient satisfaction (visual analog scale).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Supportive Care
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
Actual Study Start Date :
Nov 19, 2019
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

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.

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.

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.

Outcome Measures

Primary Outcome Measures

  1. Amsterdam Preoperative Anxiety and Information Scale (APAIS) [Day 0 (within 1 hour preceding a coronography)]

Secondary Outcome Measures

  1. Duration of hospitalization [Date hospital discharge (expected maximum of 5 days)]

  2. Blood pressure [Day 0 (within 1 hour preceding a coronography)]

  3. Cardiac frequency (beats per minute) [Day 0 (within 1 hour preceding a coronography)]

  4. Visual analog scale for satisfaction concerning care [Day 0 (within 1 hour preceding a coronography)]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 79 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHRU de Nîmes - Hôpital Universitaire Carémeau Nîmes Cedex 09 France 30029

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Nīmes

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT02742025
Other Study ID Numbers:
  • LOCAL/2016/EB-01
First Posted:
Apr 18, 2016
Last Update Posted:
Mar 18, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Hospitalier Universitaire de Nīmes
Coronary Angiography
Additional relevant MeSH terms:
Anxiety Disorders

Study Results

No Results Posted as of Mar 18, 2022