Status:
UNKNOWN
The IM-ZBULLE Study : " Z-track " and " Airlock " Techniques During Intramuscular Injection of Haloperidol Decanoate
Lead Sponsor:
Centre Hospitalier St Anne
Collaborating Sponsors:
Groupe Hospitalier Paul Guiraud
Etablissement Public de Santé Barthélemy Durand
Conditions:
Schizophrenia; Psychosis
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
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 pra...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2024
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT05995457
Start Date
September 1 2023
End Date
November 30 2024
Last Update
August 23 2023
Active Locations (1)
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1
Rayan BCHINI
Villejuif, France, 94800