The IM-ZBULLE Study : " Z-track " and " Airlock " Techniques During Intramuscular Injection of Haloperidol Decanoate
NCT ID: NCT05995457
Last Updated: 2023-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
84 participants
INTERVENTIONAL
2023-09-01
2024-11-30
Brief Summary
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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IMI techniques available, the "Z-track" and the "Airlock" limit leakage into subcutaneous tissues when the needle is withdrawn, by locking the active product into the muscular tissues.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.
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Detailed Description
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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®).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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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.
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
Control arm, Intramuscular injection as usual
Intramuscular injection involves administering the drug Haloperidol decanoate into muscle tissue using the usual technique
Intramuscular injection of Haloperidol decanoate using standard techniques
Intramuscular injection involves administering the drug Haloperidol decanoate into muscle tissue using the usual technique.
Interventions
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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
Intramuscular injection of Haloperidol decanoate using standard techniques
Intramuscular injection involves administering the drug Haloperidol decanoate into muscle tissue using the usual technique.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
ALL
No
Sponsors
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Groupe Hospitalier Paul Guiraud
UNKNOWN
Etablissement Public de Santé Barthélemy Durand
OTHER
Centre Hospitalier St Anne
OTHER
Responsible Party
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Principal Investigators
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Rayan BCHINI
Role: PRINCIPAL_INVESTIGATOR
GHU Paris Psychiatry & Neurosciences
Locations
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Rayan BCHINI
Villejuif, , France
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Rodger MA, King L. Drawing up and administering intramuscular injections: a review of the literature. J Adv Nurs. 2000 Mar;31(3):574-82. doi: 10.1046/j.1365-2648.2000.01312.x.
Wynaden D, Landsborough I, Chapman R, McGowan S, Lapsley J, Finn M. Establishing best practice guidelines for administration of intra muscular injections in the adult: a systematic review of the literature. Contemp Nurse. 2005 Dec;20(2):267-77. doi: 10.5172/conu.20.2.267.
Sanlialp Zeyrek A, Takmak S, Kurban NK, Arslan S. Systematic review and meta-analysis: Physical-procedural interventions used to reduce pain during intramuscular injections in adults. J Adv Nurs. 2019 Dec;75(12):3346-3361. doi: 10.1111/jan.14183. Epub 2019 Sep 13.
Keen MF. Comparison of intramuscular injection techniques to reduce site discomfort and lesions. Nurs Res. 1986 Jul-Aug;35(4):207-10.
Kim KS. [Comparison of two intramuscular injection technics on the severity of discomfort and lesions at the injection site]. Kanho Hakhoe Chi. 1988 Dec;18(3):257-68. doi: 10.4040/jnas.1988.18.3.257. Korean.
Quartermaine S, Taylor R. A comparative study of depot injection techniques. Nurs Times. 1995 Jul 26-Aug 1;91(30):36-9.
Mac Gabhann L. A comparison of two depot injection techniques. Nurs Stand. 1998 Jun 3-9;12(37):39-41. doi: 10.7748/ns1998.06.12.37.39.c2512.
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.
Kara D, Yapucu Gunes U. The effect on pain of three different methods of intramuscular injection: A randomized controlled trial. Int J Nurs Pract. 2016 Apr;22(2):152-9. doi: 10.1111/ijn.12358. Epub 2014 Jul 11.
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.
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.
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.
Other Identifiers
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D23-P001
Identifier Type: -
Identifier Source: org_study_id
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