evadoulim: Assessment of Pain During Intramuscular Injection Delay in Adult Psychiatry

Sponsor

Centre hospitalier de Ville-Evrard, France (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04784572

Collaborator

(none)

393

Enrollment

Location

Arm

Anticipated Duration (Months)

10.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Delayed Antipsychotic Treatment, Pharmacological Factors and Individual Factors	Other: first injection delay and second injection delay	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

393 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Assessment of Pain During Intramuscular Injection Delay in Adult Psychiatry

Actual Study Start Date :

Jan 22, 2021

Anticipated Primary Completion Date :

Jan 22, 2023

Anticipated Study Completion Date :

Jan 22, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

The Digital Scale of Pain (END) [5 seconds]
Facial Anxiety Visual Scale (EVAf) [10 seconds]
Insight scale [5 minutes]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ch Ville Evrard	Neuilly-sur-Marne		France	93330

Sponsors and Collaborators

Centre hospitalier de Ville-Evrard, France

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Januel, HEAD OF THE UNIT OF CLINICAL RESEARCH, Centre hospitalier de Ville-Evrard, France

ClinicalTrials.gov Identifier:

NCT04784572

Other Study ID Numbers:

10477M-EVADOULIM

First Posted:

Mar 5, 2021

Last Update Posted:

Mar 5, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Januel, HEAD OF THE UNIT OF CLINICAL RESEARCH, Centre hospitalier de Ville-Evrard, France

pain -injection

Study Results

No Results Posted as of Mar 5, 2021