- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02742025
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Eric Baljou, IDE
- Phone Number: +33.(0)4.66.68.31.19
- Email: eric.baljou@chu-nimes.fr
Study Locations
-
-
-
Nîmes Cedex 09, France, 30029
- CHRU de Nîmes - Hôpital Universitaire Carémeau
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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 |
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.
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 |
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.
This coronarography is scheduled as part of the patient's routine care.
This is not an experimental intervention under evaluation.
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.
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)
Time Frame: Day 0 (within 1 hour preceding a coronography)
|
Day 0 (within 1 hour preceding a coronography)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Duration of hospitalization
Time Frame: Date hospital discharge (expected maximum of 5 days)
|
Date hospital discharge (expected maximum of 5 days)
|
Blood pressure
Time Frame: Day 0 (within 1 hour preceding a coronography)
|
Day 0 (within 1 hour preceding a coronography)
|
Cardiac frequency (beats per minute)
Time Frame: Day 0 (within 1 hour preceding a coronography)
|
Day 0 (within 1 hour preceding a coronography)
|
Visual analog scale for satisfaction concerning care
Time Frame: Day 0 (within 1 hour preceding a coronography)
|
Day 0 (within 1 hour preceding a coronography)
|
Collaborators and Investigators
Investigators
- Study Director: Eric Baljou, IDE, Centre Hospitalier Universitaire de Nîmes
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LOCAL/2016/EB-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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