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

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: May 10, 2022

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).

Interventions

  • 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.

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Amsterdam Preoperative Anxiety and Information Scale (APAIS)
    • Time Frame: Day 0 (within 1 hour preceding a coronography)

Secondary Measures

  • Duration of hospitalization
    • Time Frame: Date hospital discharge (expected maximum of 5 days)
  • Blood pressure
    • Time Frame: Day 0 (within 1 hour preceding a coronography)
  • Cardiac frequency (beats per minute)
    • Time Frame: 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)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 79 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Centre Hospitalier Universitaire de Nīmes
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Eric Baljou, IDE, Study Director, Centre Hospitalier Universitaire de Nîmes

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