Ignite Creation Date:
2025-12-24 @ 6:49 PM
Ignite Modification Date:
2026-01-01 @ 7:05 AM
Study NCT ID:
NCT05995457
Status:
UNKNOWN
Last Update Posted:
2023-08-23
First Post:
2023-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The IM-ZBULLE Study : " Z-track " and " Airlock " Techniques During Intramuscular Injection of Haloperidol Decanoate
Sponsor:
Centre Hospitalier St Anne
Organization:
Study Overview
Official Title:
Efficacy of the Combination of " Z-track " and " Airlock " Techniques During Intramuscular Injection of Haloperidol Decanoate in Adult Patients With Schizophrenic or Related Disorder : A Multicenter Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2023-08
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IM-ZBULLE
Brief 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IMI techniques available, the "Z-track" and the "Airlock" limit leakage into subcutaneous tissues when the needle is withdrawn, by locking the active product into the muscular tissues.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.
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.
Detailed Description:
This is a multicenter, prospective, randomized, double-blind, controlled, study in 2 parallel groups.
Experimental and control administration protocols will be standardized to harmonize injection practices between the different nurses providing care, and to control some variables. Nurses will have been trained in these protocols and in experimental injection techniques.
The experimental group will be offered an intramuscular injection using the "Z-track" and "Airlock" techniques, while the control group will have an "usual" injection.
An intermediate analysis of futility and efficacy is planned once 50% of the planned sample has completed the study.
The object of the research is the intramuscular injection procedure - Product injected: haloperidol decanoate (Haldol Decanoas®).
Experimental and control administration protocols will be standardized to harmonize injection practices between the different nurses providing care, and to control some variables. Nurses will have been trained in these protocols and in experimental injection techniques.
The experimental group will be offered an intramuscular injection using the "Z-track" and "Airlock" techniques, while the control group will have an "usual" injection.
An intermediate analysis of futility and efficacy is planned once 50% of the planned sample has completed the study.
The object of the research is the intramuscular injection procedure - Product injected: haloperidol decanoate (Haldol Decanoas®).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: