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临床试验/NCT06062108
NCT06062108
已完成
不适用

Etude de la prévalence de la Douleur Chez le Patient Cirrhotique hospitalisé

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer2 个研究点 分布在 1 个国家目标入组 30 人2023年11月10日

概览

阶段
不适用
干预措施
Pain evaluation
疾病 / 适应症
Cirrhosis
发起方
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
入组人数
30
试验地点
2
主要终点
Prevalence of pain in cirrhotic patients hospitalized at the Dracénie hospital in Draguignan
状态
已完成
最后更新
19天前

概览

简要总结

According to the WHO, pain is an "unpleasant sensory and emotional experience, linked to existing or potential tissue damage, or described in terms suggestive of such damage". It is a legal obligation to evaluate and take care of it (law of 03/04/2022). However, there are still areas where this is not addressed, particularly in cirrhotic patients (Piano V et al. 2023).

The global prevalence of cirrhosis increased by 74.53% between 1990 and 2017 (Liu YB et al, 2022, INSERM France file and Zhai M et al. 2021). In France, the prevalence of cirrhosis is estimated to be 200,000 patients (Cohorte Constances 2017; Serfaty 2019). The causes are varied: toxic (alcohol), viral (hepatitis B, C, HIV), genetic (hemochromatosis, primary biliary cirrhosis) but also iatrogenic or linked to a metabolic syndrome, non-alcoholic fatty liver disease.

The first symptoms of cirrhosis are fatigue, loss of appetite and weight, nausea and vomiting, discomfort and abdominal pain. More serious symptoms may appear such as depression, confusion, sleep disturbances, edema of the lower limbs, ascites, severe pruritus or jaundice. All of these symptoms can be the cause of the pain.

However, to date, there are no studies in France on the epidemiology of pain in patients with cirrhosis (Piano V et al. 2023, Klinge M, et al, 2018). To evaluate the prevalence of pain in cirrhotic patients hospitalized at the Center Hospitalier de la Dracénie in Draguignan. Patients hospitalized at the Dracénie CH with a diagnosis of cirrhosis in its patients will be identified in the various departments by a referring doctor who will have to contact Dr PIANO. The latter, as investigating doctor, will then be able to select the patients meeting the inclusion criteria of the protocol and the informants of the existence of the research. He will explain the study to them in detail, give them sufficient time for reflection before obtaining their oral agreement and giving them the information-no-opposition letter.

The research will require a single consultation lasting between 15 and 45 minutes.

During the visit, the patient will be asked whether or not they are experiencing pain.

详细描述

The main objective of this study is to evaluate the prevalence of pain in cirrhotic patients hospitalized at the Dracénie hospital in Draguignan. The secondary objectives of this study are as follows: 1. Assess pain pattern 2. Assess the intensity and chronicity of pain 3. Assess the type of chronic pain 4. Assess sleep in patients with chronic pain 5. Assess the emotional state of patients with chronic pain 6. Evaluate the quality of life of patients with chronic pain Recruitment methods 30 participants will need to be recruited over a period of 6 months. Patients will be identified during their hospitalization at the Dracénie hospital as part of current practice. These patients must meet the inclusion criteria of the protocol to be recruited.

注册库
clinicaltrials.gov
开始日期
2023年11月10日
结束日期
2025年4月4日
最后更新
19天前
研究类型
Observational
性别
All

研究者

发起方
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
责任方
Sponsor

入排标准

入选标准

  • Patient with a diagnosis of cirrhosis in his history, hospitalized at the Center Hospitalier de la Dracénie;
  • Patient aged 18 or over;
  • Patient understanding and speaking the French language.

排除标准

  • Patient refusal;
  • Patient under legal protection (guardianship, curatorship, etc.) or legal protection;
  • Pregnant, parturient or breastfeeding woman;
  • Patients unable to answer questions for cognitive reasons;
  • Any other reason that, in the opinion of the investigator, could interfere with the evaluation of the study objectives.

研究组 & 干预措施

Patients with cirrhosis

Patients hospitalized during the inclusion period with cirrhosis medical history

干预措施: Pain evaluation

结局指标

主要结局

Prevalence of pain in cirrhotic patients hospitalized at the Dracénie hospital in Draguignan

时间窗: 1 day

The investigator ask the participant about the presence or absence of pain felt by the patient.

次要结局

  • Evaluating sleep in patients with chronic pain(1 day)
  • Assess pain number(1 day)
  • Assess the intensity and chronicity of pain(1 day)
  • Assess the type of chronic pain(1 day)
  • Assess pain location(1 day)
  • Evaluating quality of life in patients with chronic pain(1 day)

研究点 (2)

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