Clinical trial NCT05995457: The IM-ZBULLE Study : " Z-track " and " Airlock " Techniques During Intramuscular Injection of Haloperidol Decanoate
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Schizophrenia; Psychosis
Keywords: Schizophrenia
Haloperidol decanoate
Lead sponsor: Centre Hospitalier St Anne
Sponsor class: OTHER
Collaborators: name: Groupe Hospitalier Paul Guiraud
name: Etablissement Public de Santé Barthélemy Durand
First posted: 2023-08-16
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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IMI techniques available, the "Z-track" and the "Airlock" limit leakage into subcutaneous tissues when the needle is withdrawn, by locking the active product into the muscular tissues.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.

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®).

Eligibility criteria: 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).

Primary outcomes:
measure: pain reduction
timeFrame: Day 0 intervention day T
Secondary outcomes:
measure: Drug leakage reduction
timeFrame: Day 0 intervention day
measure: Impact of the injection
timeFrame: Day 0 to Day 3
measure: Improving participants satisfaction
timeFrame: Day 14 or Day 21 or Day 28 depending to the frequency established by the prescription1
measure: Improving the therapeutic alliance
timeFrame: Day 0 (intervention day) and Day 14 or Day 21 or Day 28 depending to the frequency established by the prescription
measure: Identifying the obstacles and levers to changing practices
timeFrame: During 14 Months
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Rayan BCHINI
Study officials:
affiliation: GHU Paris Psychiatry & Neurosciences
name: Rayan BCHINI
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bchini R, Goutte N. [Evidence-based practice and nursing: intramuscular injection in psychiatry]. Soins Psychiatr. 2023 May-Jun;44(346):21-26. doi: 10.1016/j.spsy.2023.04.006. Epub 2023 Jun 7. French.
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citation: Yilmaz DK, Dikmen Y, Kokturk F, Dedeoglu Y. The effect of air-lock technique on pain at the site of intramuscular injection. Saudi Med J. 2016 Mar;37(3):304-8. doi: 10.15537/smj.2016.3.13113.
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citation: Ayinde O, Hayward RS, Ross JDC. The effect of intramuscular injection technique on injection associated pain; a systematic review and meta-analysis. PLoS One. 2021 May 3;16(5):e0250883. doi: 10.1371/journal.pone.0250883. eCollection 2021.
citation: Heshmatifar N, Salari M, Rad M, Afshari Saleh T, Borzoee F, Rastaghi S. A New Approach on the pain management of intramuscular injection: A Triple-Blind Randomized Clinical Trial. Pain Manag Nurs. 2022 Jun;23(3):353-358. doi: 10.1016/j.pmn.2021.01.010. Epub 2021 Mar 11.
citation: Bloch Y, Mendlovic S, Strupinsky S, Altshuler A, Fennig S, Ratzoni G. Injections of depot antipsychotic medications in patients suffering from schizophrenia: do they hurt? J Clin Psychiatry. 2001 Nov;62(11):855-9. doi: 10.4088/jcp.v62n1104.