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

August 21, 2023 updated by: Centre Hospitalier St Anne

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

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IMI techniques available, the "Z-track" and the "Airlock" limit leakage into subcutaneous tissues when the needle is withdrawn, by locking the active product into the muscular tissues.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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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®).

Study Type

Interventional

Enrollment (Estimated)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional 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
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
Intramuscular injection involves administering the drug treatment Haloperidol decanoate into muscle tissue using the "Z-track" and "Airlock" techniques
Other: Control arm, Intramuscular injection as usual
Intramuscular injection involves administering the drug Haloperidol decanoate into muscle tissue using the usual technique
Other: Intramuscular injection of Haloperidol decanoate using standard techniques
Intramuscular injection involves administering the drug Haloperidol decanoate into muscle tissue using the usual technique.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain reduction
Time Frame: Day 0 intervention day T
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
Time Frame: Day 0 intervention day
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
Time Frame: Day 0 to Day 3
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
Identifying the obstacles and levers to changing practices
Time Frame: During 14 Months
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
Improving participants satisfaction
Time Frame: Day 14 or Day 21 or Day 28 depending to the frequency established by the prescription1
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
Time Frame: Day 0 (intervention day) and Day 14 or Day 21 or Day 28 depending to the frequency established by the prescription
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier St Anne

Collaborators

Etablissement Public de Santé Barthélemy Durand
Groupe Hospitalier Paul Guiraud

Investigators

  • Principal Investigator: Rayan BCHINI, GHU Paris Psychiatrie & Neurosciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2023

Primary Completion (Estimated)

September 30, 2024

Study Completion (Estimated)

November 30, 2024

Study Registration Dates

First Submitted

July 18, 2023

First Submitted That Met QC Criteria

August 8, 2023

First Posted (Actual)

August 16, 2023

Study Record Updates

Last Update Posted (Actual)

August 23, 2023

Last Update Submitted That Met QC Criteria

August 21, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D23-P001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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