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

Schizophrenia; Psychosis Clinical Trial

— IM-ZBULLE  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05995457
• Other study ID #: D23-P001
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: November 30, 2024

Study information

• Verified date: August 2023
• Source: Centre Hospitalier St Anne
• Contact: Rayan BCHINI, IPA
• Phone: 33 1 42 11 75 90
• Email: rayan.francoisbchini[@]gh-paulguiraud.fr
• Is FDA regulated: No
• Study type: Interventional

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IMI techniques available, the "Z-track" and the "Airlock" limit leakage into subcutaneous tissues when the needle is withdrawn, by locking the active product into the muscular tissues.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

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®).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 84
• Est. completion date: November 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Schizophrenia
• Schizophrenia; Psychosis

Intervention

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
• Intramuscular injection of Haloperidol decanoate using standard techniques
Intramuscular injection involves administering the drug Haloperidol decanoate into muscle tissue using the usual technique.

Locations

Country	Name	City	State
France	Rayan BCHINI	Villejuif

Sponsors (3)

Lead Sponsor	Collaborator
Centre Hospitalier St Anne	Etablissement Public de Santé Barthélemy Durand, Groupe Hospitalier Paul Guiraud

Country where clinical trial is conducted

France, 

References & Publications (13)

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. — View 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. — View 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. — View 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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View 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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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