Pre-operative Interventional Paramedical Consultation: What About the Implantable Device?

NCT07559981 | Not Yet Recruiting

• 2 other identifiers: 38RC25.03032026-A00869-42
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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). 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, we found that of 31 patients attending for the insertion of an implantable port, 11 (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). We 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

Keywords

implantable chamber; Medical Radiology Technician; paramedical consultation; patient's anxiety

Outcome Measures

Primary Outcomes (1)

• Assess the impact of a pre-implantation paramedical consultation on a patient's anxiety prior to the insertion of an implantable device.

  Comparison of the EVA-A score 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.

  J0 - Before the procedure

Secondary Outcomes (3)

• Assess the 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).

  J0 - Before the procedure

• Assess the 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.

  J0 - Before the procedure

• Assess 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.

  J-10 after paramedical consultation (only for interventional arm)

Study Arms (2)

Paramedical consultation

EXPERIMENTAL

Addition of a specific paramedical consultation lasting conducted by a MERM, prior to the procedure .

Other: Paramedical consultation

Standard coverage

NO INTERVENTION

Standard care (information provided by the oncologist + standardised written form).

Interventions

Paramedical consultation OTHER

Addition of a dedicated paramedical consultation lasting approximately 30 minutes, conducted by a MERM, prior to the procedure

Paramedical consultation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled to have an implantable port fitted in the Radiology Department at CHUGA
• Patients aged 18 or over

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

University Hospital Grenoble

Grenoble, 38043, France

Location

Related Publications (4)

• 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.

  PMID: 27401047 BACKGROUND

• Hadi 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.

  PMID: 33474606 BACKGROUND

• Bounif 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.

  PMID: 34024738 BACKGROUND

• Hornblow 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.

  PMID: 1071419 BACKGROUND

Related Links

• Mesure de l'anxiété préopératoire par l'échelle visuelle analogique
• Mise en place et évaluation de consultations pharmaceutiques pour les patients sous thérapie orale anticancéreuse au CHRU de Brest

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: April 30, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): November 1, 2029
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)