Assessment of Pain During Intramuscular Injection Delay in Adult Psychiatry
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 393
- 试验地点
- 1
- 主要终点
- The Digital Scale of Pain (END)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: first injection delay and second injection delay (Other)
结局指标
主要结局
The Digital Scale of Pain (END)
时间窗: 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)
时间窗: 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)
时间窗: 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
The Digital Scale of Pain (END)
时间窗: 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)
时间窗: 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.
次要结局
未报告次要终点
研究者
Dominique JANUEL
HEAD OF THE UNIT OF CLINICAL RESEARCH
Centre hospitalier de Ville-Evrard, France