The IM-ZBULLE Study : " Z-track " and " Airlock " Techniques During Intramuscular Injection of Ha… (NCT05995457) | Clinical Trial Compass
UnknownNot Applicable
The IM-ZBULLE Study : " Z-track " and " Airlock " Techniques During Intramuscular Injection of Haloperidol Decanoate
France84 participantsStarted 2023-09-01
Plain-language summary
Intramuscular injection (IMI) is the process of administering a drug treatment into muscle tissue. The transmission of skills in this care practice is essentially based on the experience of peers. In France, there are no official guidelines for this technical procedure.
Haloperidol decanoate is widely used in psychiatry. This long-acting antipsychotic treatment considerably reduces the risk of relapse and hospitalization. It is administered by IMI. This treatment is invasive, painful and risks complications for the patient. Nurses must ensure that the treatment is as painless as possible, and adapt their practice in line with current recommendations.
Among the various IMI techniques available, the "Z-track" and the "Airlock" limit leakage into subcutaneous tissues when the needle is withdrawn, by locking the active product into the muscular tissues. According to an exploratory study (n=303), 73% of nurses observe active product leakage after injections, and 89% of nurses are not familiar with either the "Z-track" or "Airlock" techniques.
Many foreign studies have been carried out to demonstrate the relevance of these techniques, particularly in terms of pain reduction during treatment, but the results have yet to be confirmed.
The investigators hypothesize that the combined use of the "Z-track" and "Airlock" techniques during intramuscular injection of Haloperidol decanoate is more effective in reducing patient pain than usual practice.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult ;
* having an outpatient treatment in a Mental Health Community Center ("Centre Médico-Psychologique" CMP in french) ;
* with an CIM-10 diagnosis between F20-F29 (Schizophrenia, schizotypal disorder and delusional disorders);
* communicative and able to give free and informed consent to the study;
* prescribed Haloperidol decanoate;
* covered by the french social security
Exclusion Criteria:
* Minor ;
* pregnant women ;
* with insufficient understanding of the French language to understand the VAS;
* suffering from any of the following known somatic comorbidity : coagulation disorder, leucopenia, immunosuppression;
* currently prescribed treatment: immunosuppressant, anticoagulant, antibiotic, antiretroviral, other products administered by IMI at dorsogluteal injection sites (antibiotic therapy, hormone therapy, vitamin therapy).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.