Delayed Antipsychotic Treatment, Pharmacological Factors and Individual Factors
Conditions
Keywords
pain -injection
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.
Interventions
OTHERfirst 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.
Sponsors
Centre hospitalier de Ville-Evrard, France
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
The group will have a first injection delay and then a second injection delay.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Digital Scale of Pain (END) | At the first visit during the first injection of treatment delay . It will take 5 seconds | This scale will assess pain at the injection site before and after intramuscular injection of neuroleptic treatment delay. This scale ranges from 0 (none pain) to 10 (worst possible pain). It will only take 5 seconds for the subject. This scale has good concurrent validity because it is highly correlated with others pain measurement tools (Haefeli & Elfering, 2006), including the analog visual scale of pain (r=0.95; p\<0.001; Bahreini et al., 2015). |
| Facial Anxiety Visual Scale (EVAf) | At the first visit during the first injection of treatment delay . It will take10 seconds. | This scale Assess patient anxiety before and after intramuscular injection of delayed neuroleptic therapy. It was developed by Cao et al., (2017). It is a self-assessment scale of the severity of anxiety representing facial expression during anxiety. Six faces represent different expressions of anxiety: No anxiety, Mild anxiety, Mild to Moderate Anxiety, Moderate Anxiety, Moderate to High Anxiety, and High Anxiety. |
| Insight scale (BIS) | At the first visit during the first injection of treatment delay . It will take5 minutes. | This scale will assess the knowledge of the disease, the insight of patients, prior to intramuscular injection of neuroleptic therapy delay to Visit 1 (V1). This questionnaire developed by Birchwood et al. (1994), translated and validated in French by Linder and Favrod, (2006),will allow a quick self-assessment of the patient's insight. It consists of 8 items with a duration of 5 minutes. The person can choose between 3 answers for each item: Agree, In disagreement, Uncertaine. The score is obtained by adding the score of the items: * Maximum score = 12 - Very good insight * 9 and above = good insight * Minimum score = 0 - No insight |
Countries
France
Contacts
Primary ContactRusheenthira THAVASEELAN, MSC
Backup ContactYoucef BENCHERIF, MSC
Outcome results
None listed