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Completed

NCT Number: NCT02742025

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

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.

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Key information

Conditions

Preoperative Anxiety

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inclusion visit

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

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

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

Procedure

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

Primary outcomes

  1. Amsterdam Preoperative Anxiety and Information Scale (APAIS)

    Time frame: Day 0 (within 1 hour preceding a coronography)

Secondary outcomes

  1. Duration of hospitalization

    Time frame: Date hospital discharge (expected maximum of 5 days)

  2. Blood pressure

    Time frame: Day 0 (within 1 hour preceding a coronography)

  3. Cardiac frequency (beats per minute)

    Time frame: Day 0 (within 1 hour preceding a coronography)

  4. Visual analog scale for satisfaction concerning care

    Time frame: Day 0 (within 1 hour preceding a coronography)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study 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

Acronym: HEART-LINK

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Apr 18, 2016
Registry last updated
Jun 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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