AnxietyCOPAINNCT07559981
Pre-operative Interventional Paramedical Consultation: What About the Implantable Device?
A study testing Paramedical consultation in people with Anxiety and Paramedical Consultation, run by University Hospital, Grenoble at 1 site in France.
Trial summary
The placement of implantable ports is carried out at CHUGA by several departments, including the Interventional Radiology Department. The radiology team places between 350 and 370 implantable ports each year (figures for 2023: 361, 2024: 363). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety, Paramedical Consultation
- What is being tested?
- Paramedical consultation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2027to Feb 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled to have an implantable port fitted in the Radiology Department at CHUGA
- Patients aged 18 or over
Who cannot join
- Patients with a history of implantable port placement
- Implantable port placement for a non-oncological indication
- Emergency implantable port placement that could increase the patient's anxiety (port placement scheduled as an emergency within 7 days of the oncology consultation)
- Subject currently excluded from another study
- Persons referred to in Articles L1121-5 to L1121-8 of the Public Health Code (i.e. all protected persons: pregnant women, women in labour, breastfeeding mothers, persons deprived of their liberty by judicial or administrative order, and persons subject to a legal protection measure)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
University Hospital Grenoble
Grenoble, 38043
Coralie BERNHEIM MERM, +33 4 76 76 82 94, CBernheim@chu-grenoble.fr
Marine FAURE CRA, +33 4 76 76 68 72, MFaure6@chu-grenoble.fr
About this study
The placement of implantable ports is carried out at CHUGA by several departments, including the Interventional Radiology Department.
The radiology team places between 350 and 370 implantable ports each year (figures for 2023: 361, 2024: 363).
Read more
It is a short procedure (less than an hour), carried out under local anaesthetic. Following this, the interventional radiologist makes two incisions: one at the base of the neck and the second beneath the collarbone on the same side. The olive-sized housing is positioned at the incision near the collarbone. The catheter is connected to the device and then enters the neck vein at the second incision after travelling under the skin. The two incisions are closed with a few stitches, still under local anaesthetic. After the procedure, the patient gets dressed and can go home with a prescription for nursing care. Due to a lack of available medical time, there is currently no pre-procedural consultation carried out by radiologists prior to this procedure. The information is therefore provided by the oncologist during the oncology consultation, alongside a wealth of other information regarding the oncological condition. When an appointment is made through the interventional radiology department's reception, a standardised written information sheet is sent to the patient along with the appointment letters. The MERM team in the interventional radiology department observed that information regarding the procedure's conduct almost invariably had to be repeated when the patient was admitted to the procedure suite. According to an internal department assessment conducted over one month, the investigators found that of 31 patients attending for the insertion of an implantable port, 11 patients (35.5%) were highly anxious, 9 patients (29%) had received no information at all regarding the procedure, and only 8 patients (25.8%) were not anxious and felt they had been properly informed. Furthermore, 4 patients (12.9%) did not undergo the procedure due to a major error in the management of anticoagulants, and 7 patients (22.5%) had not undergone the preoperative blood tests normally recommended.
During the pre-procedure consultation, which lasts approximately 30 minutes, you will be given full details of the examination process, from settling in the procedure room right through to the dressing. Pre- and post-operative instructions will also be provided, along with the relevant prescriptions (discontinuation of anticoagulants, Betadine shower, referral for a blood test to be carried out in the laboratory beforehand, dressings and a follow-up visit from a private nurse afterwards). The issue of transport to and from the hospital on the day of the procedure (arrangements, transport vouchers) will also be discussed. This time will be used to introduce the patient to the department and the healthcare staff who will be looking after them, using visual aids (photographs), as well as to show them a device identical to the one that will be implanted, if they wish.
Unlike the information currently provided on the day of the examination, this consultation will take place in a confidential and calm setting where the patient will also be able to ask any questions they may have.
Assessing patients' anxiety preoperatively is not easy, but the most widely validated scale is the State and Trait Anxiety Index (STAI) (1), which has been translated into French but comprises 20 items and is therefore cumbersome to administer.
The Visual Analogue Scale (VAS) is much easier to use in practice and began to be used in the context of anxiety in the 1970s (2) A prospective study (3) conducted at Poitiers University Hospital demonstrated a good correlation between the STAI scale and the Visual Analogue Scale (VAS) upon entering the operating theatre. A randomised study of 89 patients conducted at Limoges University Hospital showed that an information consultation held approximately 7 days before gastrointestinal surgery reduced patients' anxiety as assessed by the VAS-Anxiety (VAS-A) score (4).
The investigators therefore hypothesise that an information consultation conducted by a MERM would help to reduce anxiety in patients coming to our department for the placement of an implantable port in an oncological context
- Conditions
- Anxiety, Paramedical Consultation
- Being tested
- Paramedical consultation
- Keywords
- implantable chamber, Medical Radiology Technician, paramedical consultation, patient's anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paramedical consultationOther
Addition of a dedicated paramedical consultation lasting approximately 30 minutes, conducted by a MERM, prior to the procedure
| Study group | Role | What they receive |
|---|---|---|
| Paramedical consultation | Experimental | Addition of a specific paramedical consultation lasting conducted by a MERM, prior to the procedure . Receives: Other: Paramedical consultation |
| Standard coverage | No intervention | Standard care (information provided by the oncologist + standardised written form). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's anxiety during pre-implantation paramedical consultation and patient's anxiety without paramedical consultation as Assessed by EVA-A Scores on the Visual Analog Scale at Day 0 before the procedure).
Comparison of the EVA-A score (The Visual Analogue Scale is a scale used to assess anxiety. Here, we will measures the intensity of patient's anxiety on a scale of 0 who is the worthess to 10 who is the best.) at the time the patient is welcomed into the changing room between the group of patients receiving standard care in the radiology department (information provided during the oncology consultation + information sheet) and the group of patients receiving an additional paramedical information consultation.
Measured: Day 0 - Before the procedure
Secondary outcomes (3)
Impact of a pre-implantation paramedical consultation on the number of incidents preventing the implantation of an implantable port (management of anticoagulants/antiplatelet agents, blood samples taken by the patient).
Comparison of the number of patients for whom there was an error in the advice given at the time of booking the appointment (management of anticoagulants/antiplatelet agents and blood tests) in accordance with CIRSE guidelines (5) prior to the insertion of an implantable port between the two groups.
Measured: Day 0 - Before the procedure
Impact of a pre-operative paramedical consultation prior to the implantation of an implantable port on the time taken to admit the patient on the day of the procedure.
Comparison of the average waiting time (in minutes) between the two groups, from the moment the patient is admitted to the waiting room until the moment they are ready to enter the operating theatre to begin the procedure.
Measured: Day 0 - Before the procedure
Patients' views on the value of a pre-operative consultation with a healthcare professional prior to the implantation of a pacemaker, in terms of their understanding of the upcoming procedure.
Assessment of overall patient satisfaction following the consultation, measured using a 5-point Likert scale. (The Likert scale is a psychometric tool used to measure individuals' attitudes, opinions or perceptions through a series of responses on a scale ranging from agreement to disagreement. Here we have 5 points, 0 is the worthess = disagreement, 5 is the best = agreement.
Measured: Day-10 after paramedical consultation (only for interventional arm)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study startJan 2027 (estimated)
- Primary completionJan 2030 (estimated)
- Study completionFeb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients are randomised in a 1:1 ratio into two parallel groups: * Control group (C): standard care (information provided by the oncologist + standardised written information sheet). Patients are not informed of which group they have been assigned to. * Intervention group (I): addition of a dedicated paramedical consultation lasting approximately 30 minutes, conducted by a MERM, prior to the procedure. Written consent is obtained at this time.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07559981
- Sponsor's protocol ID
- 38RC25.0303
- Other IDs
- 2026-A00869-42
- Acronym
- COPAIN
- Status last verified
- Sep 2026
- First submitted
- 23 Apr 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Iyigun E, Pazar B, Tastan S. A study on reliability and validity of the Turkish version of the Face Anxiety Scale on mechanically-ventilated patients. Intensive Crit Care Nurs. 2016 Dec;37:46-51. doi: 10.1016/j.iccn.2016.05.002. Epub 2016 Jul 9.
PubMed 27401047Hadi M, Walker C, Desborough M, Basile A, Tsetis D, Hunt B, Muller-Hullsbeck S, Rand T, van Delden O, Uberoi R. CIRSE Standards of Practice on Peri-operative Anticoagulation Management During Interventional Radiology Procedures. Cardiovasc Intervent Radiol. 2021 Apr;44(4):523-536. doi: 10.1007/s00270-020-02763-4. Epub 2021 Jan 20.
PubMed 33474606Bounif C, Ducos V, Appourchaux E, Ferrero PA, Roux A, Mathonnet M, Taibi A. Does increased patient comprehension decrease preoperative anxiety before digestive surgery? J Visc Surg. 2022 Apr;159(2):114-120. doi: 10.1016/j.jviscsurg.2021.02.009. Epub 2021 May 20.
PubMed 34024738Hornblow AR, Kidson MA. The visual analogue scale for anxiety: a validation study. Aust N Z J Psychiatry. 1976 Dec;10(4):339-41. doi: 10.3109/00048677609159523. No abstract available.
PubMed 1071419
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-operative Interventional Paramedical Consultation: What About the Implantable Device?
- ClinicalTrials.gov ID
- NCT07559981
- Acronym / sponsor ID
- COPAIN / 38RC25.0303
- Conditions
- Anxiety, Paramedical Consultation
- Keywords
- implantable chamber, Medical Radiology Technician, paramedical consultation, patient's anxiety
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Feb 2030 (estimated)
- First posted
- 30 Apr 2026 (actual)
- 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 placement of implantable ports is carried out at CHUGA by several departments, including the Interventional Radiology Department.
The radiology team places between 350 and 370 implantable ports each year (figures for 2023: 361, 2024: 363).
It is a short procedure (less than an hour), carried out under local anaesthetic. Following this, the interventional radiologist makes two incisions: one at the base of the neck and the second beneath the collarbone on the same side. The olive-sized housing is positioned at the incision near the collarbone. The catheter is connected to the device and then enters the neck vein at the second incision after travelling under the skin. The two incisions are closed with a few stitches, still under local anaesthetic. After the procedure, the patient gets dressed and can go home with a prescription for nursing care. Due to a lack of available medical time, there is currently no pre-procedural consultation carried out by radiologists prior to this procedure. The information is therefore provided by the oncologist during the oncology consultation, alongside a wealth of other information regarding the oncological condition. When an appointment is made through the interventional radiology department's reception, a standardised written information sheet is sent to the patient along with the appointment letters. The MERM team in the interventional radiology department observed that information regarding the procedure's conduct almost invariably had to be repeated when the patient was admitted to the procedure suite. According to an internal department assessment conducted over one month, the investigators found that of 31 patients attending for the insertion of an implantable port, 11 patients (35.5%) were highly anxious, 9 patients (29%) had received no information at all regarding the procedure, and only 8 patients (25.8%) were not anxious and felt they had been properly informed. Furthermore, 4 patients (12.9%) did not undergo the procedure due to a major error in the management of anticoagulants, and 7 patients (22.5%) had not undergone the preoperative blood tests normally recommended.
During the pre-procedure consultation, which lasts approximately 30 minutes, you will be given full details of the examination process, from settling in the procedure room right through to the dressing. Pre- and post-operative instructions will also be provided, along with the relevant prescriptions (discontinuation of anticoagulants, Betadine shower, referral for a blood test to be carried out in the laboratory beforehand, dressings and a follow-up visit from a private nurse afterwards). The issue of transport to and from the hospital on the day of the procedure (arrangements, transport vouchers) will also be discussed. This time will be used to introduce the patient to the department and the healthcare staff who will be looking after them, using visual aids (photographs), as well as to show them a device identical to the one that will be implanted, if they wish.
Unlike the information currently provided on the day of the examination, this consultation will take place in a confidential and calm setting where the patient will also be able to ask any questions they may have.
Assessing patients' anxiety preoperatively is not easy, but the most widely validated scale is the State and Trait Anxiety Index (STAI) (1), which has been translated into French but comprises 20 items and is therefore cumbersome to administer.
The Visual Analogue Scale (VAS) is much easier to use in practice and began to be used in the context of anxiety in the 1970s (2) A prospective study (3) conducted at Poitiers University Hospital demonstrated a good correlation between the STAI scale and the Visual Analogue Scale (VAS) upon entering the operating theatre. A randomised study of 89 patients conducted at Limoges University Hospital showed that an information consultation held approximately 7 days before gastrointestinal surgery reduced patients' anxiety as assessed by the VAS-Anxiety (VAS-A) score (4).
The investigators therefore hypothesise that an information consultation conducted by a MERM would help to reduce anxiety in patients coming to our department for the placement of an implantable port in an oncological context
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients are randomised in a 1:1 ratio into two parallel groups: * Control group (C): standard care (information provided by the oncologist + standardised written information sheet). Patients are not informed of which group they have been assigned to. * Intervention group (I): addition of a dedicated paramedical consultation lasting approximately 30 minutes, conducted by a MERM, prior to the procedure. Written consent is obtained at this time.
| Arm | Type | Receives |
|---|---|---|
| Paramedical consultation | Experimental | Other: Paramedical consultationAddition of a specific paramedical consultation lasting conducted by a MERM, prior to the procedure . |
| Standard coverage | No intervention | –Standard care (information provided by the oncologist + standardised written form). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients scheduled to have an implantable port fitted in the Radiology Department at CHUGA
- Patients aged 18 or over
Key exclusion criteria (5 listed)
- Patients with a history of implantable port placement
- Implantable port placement for a non-oncological indication
- Emergency implantable port placement that could increase the patient's anxiety (port placement scheduled as an emergency within 7 days of the oncology consultation)
- Subject currently excluded from another study
- Persons referred to in Articles L1121-5 to L1121-8 of the Public Health Code (i.e. all protected persons: pregnant women, women in labour, breastfeeding mothers, persons deprived of their liberty by judicial or administrative order, and persons subject to a legal protection measure)
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 |
|---|---|---|
| Paramedical consultationAddition of a dedicated paramedical consultation lasting approximately 30 minutes, conducted by a MERM, prior to the procedure | Other | Paramedical consultation |
Primary outcome
Patient's anxiety during pre-implantation paramedical consultation and patient's anxiety without paramedical consultation as Assessed by EVA-A Scores on the Visual Analog Scale at Day 0 before the procedure).
Time frame: Day 0 - Before the procedure
Comparison of the EVA-A score (The Visual Analogue Scale is a scale used to assess anxiety. Here, we will measures the intensity of patient's anxiety on a scale of 0 who is the worthess to 10 who is the best.) at the time the patient is welcomed into the changing room between the group of patients receiving standard care in the radiology department (information provided during the oncology consultation + information sheet) and the group of patients receiving an additional paramedical information consultation.
3 secondary outcomes
Impact of a pre-implantation paramedical consultation on the number of incidents preventing the implantation of an implantable port (management of anticoagulants/antiplatelet agents, blood samples taken by the patient).
Time frame: Day 0 - Before the procedure
Impact of a pre-operative paramedical consultation prior to the implantation of an implantable port on the time taken to admit the patient on the day of the procedure.
Time frame: Day 0 - Before the procedure
Patients' views on the value of a pre-operative consultation with a healthcare professional prior to the implantation of a pacemaker, in terms of their understanding of the upcoming procedure.
Time frame: Day-10 after paramedical consultation (only for interventional arm)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Background: PubMed 27401047Iyigun E, Pazar B, Tastan S. A study on reliability and validity of the Turkish version of the Face Anxiety Scale on mechanically-ventilated patients. Intensive Crit Care Nurs. 2016 Dec;37:46-51. doi: 10.1016/j.iccn.2016.05.002. Epub 2016 Jul 9.
- Background: PubMed 33474606Hadi M, Walker C, Desborough M, Basile A, Tsetis D, Hunt B, Muller-Hullsbeck S, Rand T, van Delden O, Uberoi R. CIRSE Standards of Practice on Peri-operative Anticoagulation Management During Interventional Radiology Procedures. Cardiovasc Intervent Radiol. 2021 Apr;44(4):523-536. doi: 10.1007/s00270-020-02763-4. Epub 2021 Jan 20.
- Background: PubMed 34024738Bounif C, Ducos V, Appourchaux E, Ferrero PA, Roux A, Mathonnet M, Taibi A. Does increased patient comprehension decrease preoperative anxiety before digestive surgery? J Visc Surg. 2022 Apr;159(2):114-120. doi: 10.1016/j.jviscsurg.2021.02.009. Epub 2021 May 20.
- Background: PubMed 1071419Hornblow AR, Kidson MA. The visual analogue scale for anxiety: a validation study. Aust N Z J Psychiatry. 1976 Dec;10(4):339-41. doi: 10.3109/00048677609159523. No abstract available.
- Mesure de l'anxiété préopératoire par l'échelle visuelle analogiqueLink provided by the sponsor.
- Mise en place et évaluation de consultations pharmaceutiques pour les patients sous thérapie orale anticancéreuse au CHRU de BrestLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paramedical consultation in people with Anxiety and Paramedical Consultation, run by University Hospital, Grenoble 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 2 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 2 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient's anxiety during pre-implantation paramedical consultation and patient's anxiety without paramedical consultation as Assessed by EVA-A Scores on the Visual Analog Scale at Day 0 before the procedure). (time frame: Day 0 - Before the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07559981, which also lists 4 linked publications.
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 2 Oct 2026.