Preoperative AnxietyHEART-LINKNCT02742025
Effect of an Educational and Explanatory Program for a Surgical Act on Preoperative Anxiety
A study testing Inclusion visit, Nurse consultation and Telephone contact in people with Preoperative Anxiety, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Preoperative Anxiety
- What is being tested?
- Inclusion visit, Nurse consultation and Telephone contact
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteFrance
- Study dates
- 19 Nov 2019to 10 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
The secondary objectives of this study are to assess the impact of the HEARTLINK program on the following parameters:
- Duration of hospital stay; B. Per operative blood and heart rate?; C. Patient satisfaction (visual analog scale).
- Conditions
- Preoperative Anxiety
- Being tested
- Inclusion visit, Nurse consultation, Telephone contact, Coronarography on day 0
- Keywords
- Coronary Angiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inclusion visitOther
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 consultationOther
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 contactOther
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 0Procedure or surgery
This coronarography is scheduled as part of the patient's routine care. This is not an experimental intervention under evaluation.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | Other | Patients randomized to this arm will have standard care with no extra interventions.
Intervention: Inclusion visit
Intervention: Coronarography on day 0 Receives: Other: Inclusion visit; Procedure: Coronarography on day 0 |
| HEARTLINK | Experimental | 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 Receives: Other: Inclusion visit; Other: Nurse consultation; Other: Telephone contact; Procedure: Coronarography on day 0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amsterdam Preoperative Anxiety and Information Scale (APAIS)
Measured: Day 0 (within 1 hour preceding a coronography)
Secondary outcomes (4)
Duration of hospitalization
Measured: Date hospital discharge (expected maximum of 5 days)
Blood pressure
Measured: Day 0 (within 1 hour preceding a coronography)
Cardiac frequency (beats per minute)
Measured: Day 0 (within 1 hour preceding a coronography)
Visual analog scale for satisfaction concerning care
Measured: Day 0 (within 1 hour preceding a coronography)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2016 (estimated)
- Study start19 Nov 2019
- Primary completion10 May 2022
- Study completion10 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative AnxietyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Baljou, IDE, Study director, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02742025
- Sponsor's protocol ID
- LOCAL/2016/EB-01
- Acronym
- HEART-LINK
- Status last verified
- Jun 2023
- First submitted
- 7 Apr 2016
- Last updated
- 23 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02742025
- Acronym / sponsor ID
- HEART-LINK / LOCAL/2016/EB-01
- Conditions
- Preoperative Anxiety
- Keywords
- Coronary Angiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 19 Nov 2019 (actual)
- Primary completion
- 10 May 2022 (actual)
- Study completion
- 10 May 2022 (actual)
- First posted
- 18 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Duration of hospital stay; B. Per operative blood and heart rate?; C. Patient satisfaction (visual analog scale).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care | Other | Other: Inclusion visit, Procedure: Coronarography on day 0Patients randomized to this arm will have standard care with no extra interventions. Intervention: Inclusion visit Intervention: Coronarography on day 0 |
| HEARTLINK | Experimental | Other: Inclusion visit, Other: Nurse consultation, Other: Telephone contact, Procedure: Coronarography on day 0Patients 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 |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inclusion visitThis 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 | HEARTLINK, Standard Care |
| Nurse consultationThis 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 | HEARTLINK |
| Telephone contactA 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. | Other | HEARTLINK |
| Coronarography on day 0This coronarography is scheduled as part of the patient's routine care. This is not an experimental intervention under evaluation. | Procedure or surgery | HEARTLINK, Standard Care |
Primary outcome
Amsterdam Preoperative Anxiety and Information Scale (APAIS)
Time frame: Day 0 (within 1 hour preceding a coronography)
4 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Baljou, IDE study director
Centre Hospitalier Universitaire de Nīmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inclusion visit, Nurse consultation and Telephone contact in people with Preoperative Anxiety, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amsterdam Preoperative Anxiety and Information Scale (APAIS) (time frame: Day 0 (within 1 hour preceding a coronography)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2023.