The IM-ZBULLE Study :  Z-track  and  Airlock  Techniques During Intramuscular Injection of Haloperidol Decanoate

Study Overview
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Brief Summary
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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IMI techniques available, the Z-track and the Airlock limit leakage into subcutaneous tissues when the needle is withdrawn, by locking the active product into the muscular tissues.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
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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®).

Official Title
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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

Conditions
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Schizophrenia; Psychosis

Intervention / Treatment
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* Other: Intramuscular injection of Haloperidol decanoate using the Z-track and Airlock techniques
* Other: Intramuscular injection of Haloperidol decanoate using standard techniques


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intramuscular injection of Haloperidol decanoate using the Z-track and Airlock techniques<br>Intramuscular injection involves administering the drug treatment Haloperidol decanoate into muscle tissue using the Z-track and Airlock techniques. | Other: Intramuscular injection of Haloperidol decanoate using the Z-track and Airlock techniques<br>* Intramuscular injection involves administering the drug treatment Haloperidol decanoate into muscle tissue using the Z-track and Airlock techniques<br>|
| Other: Control arm, Intramuscular injection as usual<br>Intramuscular injection involves administering the drug Haloperidol decanoate into muscle tissue using the usual technique | Other: Intramuscular injection of Haloperidol decanoate using standard techniques<br>* Intramuscular injection involves administering the drug Haloperidol decanoate into muscle tissue using the usual technique.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain reduction | To evaluate the efficacy of combining the Z-track and Airlock techniques concerning reducing pain in adult patients treated with Haloperidol decanoate. The primary outcome measure is pain reduction, assessed using a millimeter-scale visual analogic scale (VAS) to measure pain perceived by the patient 5 minutes after the treatment. The score is between 0 (minimum) and 10 (maximum) centimeters. The higher the score, the worse the result. | Day 0 intervention day T | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug leakage reduction | To measure the loss (leakage) of active product when the needle is withdrawn : The outcome measure is a reduction in the loss of active product by assessing the diameter (using a millimeter scale) of active product that flow back through the puncture site using an absorbent pad. | Day 0 intervention day | 
| Impact of the injection | To measure the impact of combining the Z-track and Airlock techniques on potential complications related to treatment : The outcome measure is the reduction in signs of secondary complications, as measured by a pre- and post-injection clinical examination and a phone call to the patient between Day 1 and Day 3. | Day 0 to Day 3 | 
| Improving participants satisfaction | To measure overall patient satisfaction with the combination of Z-track and Airlock intramuscular injection techniques. The outcome measure is participant satisfaction, assessed using Attkisson's CSQ-8 questionnaire. This scale comprises 8 questions. Depending on the answer, each question awards 1 to 4 points. The score is therefore between 8 (minimum) and 32 (maximum) points. The higher the score, the better the result. | Day 14 or Day 21 or Day 28 depending to the frequency established by the prescription1 | 
| Improving the therapeutic alliance | To measure therapeutic alliance during follow-up :The outcome measure is the overall therapeutic alliance score, using the Working Alliance Inventory (WAI) scale before and after intervention. This scale comprises 12 questions. Each question awards 1 to 5 points, depending on the answer. The score is between 12 (minimum) and 60 (maximum) points. The higher the score, the better the result. | Day 0 (intervention day) and Day 14 or Day 21 or Day 28 depending to the frequency established by the prescription | 
| Identifying the obstacles and levers to changing practices | To identify the levers and obstacles to nurses' change of practice : The outcome measure is the identification of levers and obstacles to change in professional practice among psychiatric nurses, by means of a complementary qualitative descriptive study. | During 14 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia, Haloperidol decanoate