Delayed Antipsychotic Treatment, Pharmacological Factors and Individual FactorsevadoulimNCT04784572
Assessment of Pain During Intramuscular Injection Delay in Adult Psychiatry
A study testing first injection delay and second injection delay in people with Delayed Antipsychotic Treatment, Pharmacological Factors and Individual Factors, run by Centre hospitalier de Ville-Evrard, France at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delayed Antipsychotic Treatment, Pharmacological Factors and Individual Factors
- What is being tested?
- first injection delay and second injection delay
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 393 participants
- Where
- 1 siteFrance
- Study dates
- 22 Jan 2021to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Ch Ville Evrard
Neuilly-sur-Marne, 93330
Dominique Januel, MBBS
Samir JABRI, BSC
About this study
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.
- Being tested
- first injection delay and second injection delay
- Keywords
- pain -injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
first injection delay and second injection delayOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: first injection delay and second injection delay |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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
Measured: At the first visit during the first injection of treatment delay . It will take5 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start22 Jan 2021
- Primary completion30 Sep 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delayed Antipsychotic Treatment, Pharmacological Factors and Individual FactorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The group will have a first injection delay and then a second injection delay.
- Masking
- None (open label)
- Enrolment
- 393 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre hospitalier de Ville-Evrard, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dominique JANUEL, Centre hospitalier de Ville-Evrard, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04784572
- Sponsor's protocol ID
- 10477M-EVADOULIM
- Acronym
- evadoulim
- Status last verified
- Mar 2024
- First submitted
- 3 Mar 2021
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Pain During Intramuscular Injection Delay in Adult Psychiatry
- ClinicalTrials.gov ID
- NCT04784572
- Acronym / sponsor ID
- evadoulim / 10477M-EVADOULIM
- Keywords
- pain -injection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 393 participants (estimated)
- Lead sponsor
- Centre hospitalier de Ville-Evrard, FranceUniversity, hospital or other
- Study start
- 22 Jan 2021 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 5 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The group will have a first injection delay and then a second injection delay.
| Arm | Type | Receives |
|---|---|---|
| First injection delay and second injection delay | Other | Other: first injection delay and second injection delayDuring 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| first injection delay and second injection delayDuring 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. | Other | First injection delay and second injection delay |
Primary outcome
The Digital Scale of Pain (END)
Time frame: 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).
The Digital Scale of Pain (END)
Time frame: At the second 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)
Time frame: 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.
Facial Anxiety Visual Scale (EVAf)
Time frame: At the second visit during the first injection of treatment delay . It will take 10 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)
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing first injection delay and second injection delay in people with Delayed Antipsychotic Treatment, Pharmacological Factors and Individual Factors, run by Centre hospitalier de Ville-Evrard, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rusheenthira THAVASEELAN, MSC (0143093232, r.thavaseelan@epsve.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Digital Scale of Pain (END) (time frame: At the first visit during the first injection of treatment delay . It will take 5 seconds). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.