Assessment of Pain During Intramuscular Injection Delay in Adult Psychiatry (evadoulim)

Centre hospitalier de Ville-Evrard, France

Status: Enrolling

Conditions: Delayed Antipsychotic Treatment, Pharmacological Factors and Individual Factors

Treatments: Other: first injection delay and second injection delay

Study type: Interventional

Funder types: Other

Identifiers

NCT04784572

10477M-EVADOULIM

Details and patient eligibility

About

Since psychiatry is still too often confronted with a dichotomy between psyche and soma, the assessment of pain and anxiety at RMI is still rarely done (Willer et al., 1982). The objective of this exploratory study is to evaluate the influence of pharmacological factors (type of injected molecules, injection frequency, injection site, treatment duration, treatment dose, time since last injection) and individual about the pain perceived when injecting antipsychotic therapy (diagnosis, sex, age, weight, duration of illness, level of anxiety, psychiatric and somatic comorbidity, insight). In the future, this study will develop a suitable procedure to limit pain and anxiety during RMI. Taking these dimensions into account will probably allow a better compliance of patients for this type of care, and thus a decrease in the number of relapses in the long term.

Enrollment: 393 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients (Males, Females)
• Over the age of 18
• Hospitalized or outpatient
• Patient affiliated with social security, State Medical Aid (AME)
• With prescription of antipsychotic delay by intramuscular injection
• French language mastered
• Given oral consent to pass the self-assessment scales

Exclusion criteria

• Patients on long-term analgesic treatment, daily
• Patients with chronic pain with or without analgesic treatment
• Patient not communicating
• Pregnant woman, parturint and nursing mother
• Person deprived of liberty by judicial or administrative decision
• Minor and person subject to legal protection: guardianship or curatorship

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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393 participants in 1 patient group

First injection delay and second injection delay

Other group

Description:

During the first injection, the patient will make 3 scales: END, EVAF and insight and there will be an assessment of induration, redness and swelling done with nurses. During the second injection, the patient will perform the END and EVAF scale and then follow up with a maintenance

Treatment:

Other: first injection delay and second injection delay