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

Not Applicable

Completed

• Conditions: Preoperative Anxiety
• Interventions: Other: Inclusion visit; Other: Nurse consultation; Other: Telephone contact; Procedure: Coronarography on day 0

• Registration Number: NCT02742025
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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).

Study Timeline

• Study First Submitted: 2016-04-07
• Study First Submitted QC: 2016-04-13
• Study First Posted: 2016-04-18
• Study Start: 2019-11-19
• Primary Completion: 2022-05-10
• Study Completion: 2022-05-10
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-22
• Last Update Posted: 2023-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HEARTLINK	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
HEARTLINK	Telephone contact	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
Standard Care	Inclusion visit	Patients randomized to this arm will have standard care with no extra interventions. Intervention: Inclusion visit Intervention: Coronarography on day 0
HEARTLINK	Inclusion visit	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
Standard Care	Coronarography on day 0	Patients randomized to this arm will have standard care with no extra interventions. Intervention: Inclusion visit Intervention: Coronarography on day 0
HEARTLINK	Nurse consultation	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

Primary Outcome Measures

Name	Time	Method
Amsterdam Preoperative Anxiety and Information Scale (APAIS)	Day 0 (within 1 hour preceding a coronography)

Secondary Outcome Measures

Name	Time	Method
Duration of hospitalization	Date hospital discharge (expected maximum of 5 days)
Visual analog scale for satisfaction concerning care	Day 0 (within 1 hour preceding a coronography)
Blood pressure	Day 0 (within 1 hour preceding a coronography)
Cardiac frequency (beats per minute)	Day 0 (within 1 hour preceding a coronography)

Trial Locations

Locations (1)

CHRU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 09, France