NCT06062108

Prevalence of Pain in Hospitalized Cirrhotic Patients

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Cirrhosis
• Hepatic Fibrosis
• Pain, Acute
• Pain, Chronic
• Pain, Neuropathic

Interventions

Type	Name	Description
OTHER	Pain evaluation	All included patients will have an evaluation of their pain, if they have no pain, the assessment stop with one date (pain or no pain), if they have pain, an assessment is done (localization of the pain, pain intensity), if they have a pain duration over 3 months, a DN4 questionnaire, HAD scale, ISI scale and SF-1 questionnaire is evaluated.

Timeline

• Start date: 2023-11-10
• Primary completion: 2025-04-04
• Completion: 2025-04-04
• First posted: 2023-10-02
• Last updated: 2026-04-13

Locations

1 site across 1 country: France