Assessment of Pain During Intramuscular Injection Delay in Adult Psychiatry

NCT04784572 | Recruiting

• 1 other identifier: 10477M-EVADOULIM
• Study Type: interventional
• Target: 393
• Locations: 1 country
• Sites: 1

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

Keywords

pain -injection

Outcome Measures

Primary Outcomes (5)

• 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.

Study Arms (1)

First injection delay and second injection delay

OTHER

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

Interventions

first injection delay and second injection delay 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.

First injection delay and second injection delay

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre hospitalier de Ville-Evrard, France: lead

Study Sites (1)

Ch Ville Evrard

Neuilly-sur-Marne, 93330, France

RECRUITING

Central Study Contacts

Rusheenthira THAVASEELAN, MSC

CONTACT

0143093232; r.thavaseelan@epsve.fr

Youcef BENCHERIF, MSC

CONTACT

0143093232; y.bencherif@epsve.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: HEAD OF THE UNIT OF CLINICAL RESEARCH

Model Details: The group will have a first injection delay and then a second injection delay.

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: March 5, 2021
• Study Start: January 22, 2021
• Primary Completion: September 30, 2024
• Study Completion: December 31, 2024
• Last Updated: March 6, 2024

Record last verified: 2024-03

Locations

FR (1)