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

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.

Study Overview

• Status: Recruiting
• Conditions: Delayed Antipsychotic Treatment, Pharmacological Factors and Individual Factors
• Intervention / Treatment: Other: first injection delay and second injection delay

• Study Type: Interventional
• Enrollment (Estimated): 393
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rusheenthira THAVASEELAN, Msc; Phone Number: 0143093232; Email: r.thavaseelan@epsve.fr
• Study Contact Backup: Name: Youcef BENCHERIF, MSC; Phone Number: 0143093232; Email: y.bencherif@epsve.fr

Study Locations

• France
  • Neuilly-sur-Marne, France, 93330
    • Recruiting
    • Ch Ville Evrard
    • Contact: Dominique Januel, MBBS
    • Principal Investigator: Samir JABRI, BSC
    • Sub-Investigator: Dominique Januel, MBBS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Digital Scale of Pain (END)	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).	At the first visit during the first injection of treatment delay . It will take 5 seconds
The Digital Scale of Pain (END)	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).	At the second visit during the first injection of treatment delay . It will take 5 seconds
Facial Anxiety Visual Scale (EVAf)	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.	At the first visit during the first injection of treatment delay . It will take10 seconds.
Facial Anxiety Visual Scale (EVAf)	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.	At the second visit during the first injection of treatment delay . It will take 10 seconds.
Insight scale (BIS)	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	At the first visit during the first injection of treatment delay . It will take5 minutes.

Collaborators and Investigators

• Sponsor: Centre hospitalier de Ville-Evrard, France

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2021
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: March 3, 2021
• First Submitted That Met QC Criteria: March 4, 2021
• First Posted (Actual): March 5, 2021

Study Record Updates

• Last Update Posted (Actual): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 3, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: pain -injection
• Other Study ID Numbers: 10477M-EVADOULIM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No