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

NCT05995457 | Unknown

• 1 other identifier: D23-P001
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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IMI techniques available, the "Z-track" and the "Airlock" limit leakage into subcutaneous tissues when the needle is withdrawn, by locking the active product into the muscular tissues.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

Conditions

Schizophrenia; Psychosis

Keywords

Schizophrenia; Haloperidol decanoate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Drug leakage reduction

  Day 0 intervention day

• Impact of the injection

  Day 0 to Day 3

• Improving participants satisfaction

  Day 14 or Day 21 or Day 28 depending to the frequency established by the prescription1

• Improving the therapeutic alliance

  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

  During 14 Months

Study Arms (2)

Intramuscular injection of Haloperidol decanoate using the "Z-track" and "Airlock" techniques

EXPERIMENTAL

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

Control arm, Intramuscular injection as usual

OTHER

Intramuscular injection involves administering the drug Haloperidol decanoate into muscle tissue using the usual technique

Other: Intramuscular injection of Haloperidol decanoate using standard techniques

Interventions

Intramuscular injection of Haloperidol decanoate using the "Z-track" and "Airlock" techniques OTHER

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 of Haloperidol decanoate using standard techniques OTHER

Intramuscular injection involves administering the drug Haloperidol decanoate into muscle tissue using the usual technique.

Control arm, Intramuscular injection as usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Centre Hospitalier St Anne: lead
• Groupe Hospitalier Paul Guiraud: collaborator
• Etablissement Public de Santé Barthélemy Durand: collaborator

Study Sites (1)

Rayan BCHINI

Villejuif, 94800, France

Location

Related Publications (13)

• 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.

  PMID: 37328226 BACKGROUND

• 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.

  PMID: 10718876 BACKGROUND

• 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.

  PMID: 16393108 BACKGROUND

• 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.

  PMID: 31452229 BACKGROUND

• Keen MF. Comparison of intramuscular injection techniques to reduce site discomfort and lesions. Nurs Res. 1986 Jul-Aug;35(4):207-10.

  PMID: 3636818 BACKGROUND

• 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.

  PMID: 3230758 BACKGROUND

• Quartermaine S, Taylor R. A comparative study of depot injection techniques. Nurs Times. 1995 Jul 26-Aug 1;91(30):36-9.

  PMID: 7644369 BACKGROUND

• 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.

  PMID: 9732632 BACKGROUND

• 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.

  PMID: 26905354 BACKGROUND

• 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.

  PMID: 25039702 BACKGROUND

• 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.

  PMID: 33939726 BACKGROUND

• 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.

  PMID: 33714700 BACKGROUND

• 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.

  PMID: 11775044 BACKGROUND

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Rayan BCHINI

  GHU Paris Psychiatry & Neurosciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rayan BCHINI, IPA

CONTACT

33 1 42 11 75 90; rayan.francoisbchini@gh-paulguiraud.fr

Cécile BERGOT

CONTACT

C.BERGOT@ghu-paris.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Advanced practice nurses (APNs) will carry out clinical examinations before and after the treatment. They will not be present during the treatment, and the patient will not know the technique used, in order to ensure a double-blind evaluation. Only the nurses performing the injection will be aware of the technique used (experimental or control).
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: August 16, 2023
• Study Start: September 1, 2023
• Primary Completion: September 30, 2024
• Study Completion: November 30, 2024
• Last Updated: August 23, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)