Clinical trial NCT04784572: Assessment of Pain During Intramuscular Injection Delay in Adult Psychiatry
Official title: Assessment of Pain During Intramuscular Injection Delay in Adult Psychiatry
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Delayed Antipsychotic Treatment, Pharmacological Factors and Individual Factors
Keywords: pain -injection
Lead sponsor: Centre hospitalier de Ville-Evrard, France
Sponsor class: OTHER
First posted: 2021-03-05
Enrollment: 393
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The group will have a first injection delay and then a second injection delay.
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: The Digital Scale of Pain (END)
timeFrame: At the first visit during the first injection of treatment delay . It will take 5 seconds
measure: The Digital Scale of Pain (END)
timeFrame: At the second visit during the first injection of treatment delay . It will take 5 seconds
measure: Facial Anxiety Visual Scale (EVAf)
timeFrame: At the first visit during the first injection of treatment delay . It will take10 seconds.
measure: Facial Anxiety Visual Scale (EVAf)
timeFrame: At the second visit during the first injection of treatment delay . It will take 10 seconds.
measure: Insight scale (BIS)
timeFrame: At the first visit during the first injection of treatment delay . It will take5 minutes.
Secondary outcomes:
Other outcomes:
Locations:
city: Neuilly-sur-Marne
country: France
facility: Ch Ville Evrard
Study officials:
References: