Assessment of Pain During Intramuscular Injection Delay in Adult Psychiatry

NCT ID: NCT04784572

Last Updated: 2024-03-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 393 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-22
• Study Completion Date: 2024-12-31

Brief Summary

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.

Conditions

Delayed Antipsychotic Treatment, Pharmacological Factors and Individual Factors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

First injection delay and second injection delay

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

Group Type: OTHER

first injection delay and second injection delay

Intervention Type: OTHER

During the first injection, the patient will make END scale for 5 seconds, EVAF scale for 10 seconds and insight scale for 5 minutes.

The second injection the patient will make END scale for 5 seconds and EVAF scale for 10 seconds and then a maintenance.

Interventions

first injection delay and second injection delay

During the first injection, the patient will make END scale for 5 seconds, EVAF scale for 10 seconds and insight scale for 5 minutes.

The second injection the patient will make END scale for 5 seconds and EVAF scale for 10 seconds and then a maintenance.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre hospitalier de Ville-Evrard, France

OTHER

Sponsor Role: lead

Responsible Party

Dominique JANUEL

HEAD OF THE UNIT OF CLINICAL RESEARCH

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ch Ville Evrard

Neuilly-sur-Marne, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Rusheenthira THAVASEELAN, MSC

Role: CONTACT

r.thavaseelan@epsve.fr

0143093232

Youcef BENCHERIF, MSC

Role: CONTACT

y.bencherif@epsve.fr

0143093232

Facility Contacts

Dominique Januel, MBBS

Role: primary

Other Identifiers

10477M-EVADOULIM

Identifier Type: -

Identifier Source: org_study_id