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临床试验/NCT06617728
NCT06617728已完成不适用

Beyond the Quake: Exploring the Persistence of Phantom Limb Pain in Amputees from the 2023 Türkiye Earthquake

Mesut Bakır1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2023年2月6日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
39
试验地点
1
主要终点
Prevalence of phantom limb pain

研究概览

简要总结

The goal of this observational study is to investigate the prevalence and persistence of phantom limb pain (PLP) among amputees who experienced limb loss due to injuries sustained during the 2023 Türkiye earthquake. The main questions it aims to answer are:

What is the prevalence of phantom limb pain among earthquake-related amputees at different follow-up intervals? How do different pain management strategies, such as regional analgesia versus intravenous analgesia, affect the severity and persistence of phantom limb pain? Researchers will compare participants receiving regional analgesia to those receiving intravenous analgesia to see if regional techniques are associated with lower rates of phantom limb pain and improved quality of life.

Participants will:

Complete pain assessments using standardized questionnaires at 1 week, 3 months, 6 months, and 12 months post-amputation.

Provide information on their pain management experiences and the impact on their daily activities.

详细描述

This observational study aims to assess the prevalence, characteristics, and management of phantom limb pain (PLP) among individuals who underwent amputations due to injuries sustained during the 2023 Türkiye earthquake. Conducted at the Mersin University Pain Clinic, the study involves 39 patients who were followed for 12 months post-amputation. The primary focus is to evaluate how different analgesic methods, such as regional versus intravenous analgesia, influence the development and persistence of PLP and associated phantom limb sensations (PLS).

Patients were recruited from those treated at Mersin University Hospital immediately following the earthquake. Inclusion criteria included individuals aged 5 years and older who experienced amputation due to earthquake-related trauma. Exclusion criteria included pre-existing psychiatric disorders, history of neuropathic pain in the amputated limb, or inability to communicate due to cognitive impairment.

The study's primary outcomes are the prevalence of PLP and PLS at 1 week, 3 months, 6 months, and 12 months post-amputation. Pain intensity is measured using the Visual Analog Scale (VAS), and the impact of different analgesic techniques on pain severity and quality of life is analyzed. Secondary outcomes include the incidence of residual limb pain and the effectiveness of various pain management strategies in reducing pain symptoms over time.

This study is expected to contribute valuable insights into the management of PLP in disaster-related amputees, providing evidence to guide clinical practice and improve patient outcomes in similar post-disaster settings.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
5 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Individuals aged 5 years and older.
  • •Patients who have undergone amputation due to injuries sustained during the 2023 Türkiye earthquake.
  • •Experiencing phantom limb pain (PLP) as confirmed by a structured questionnaire.
  • •Able to provide informed consent or have consent provided by a legal guardian if under the age of 18.

排除标准

  • •Pre-existing psychiatric disorders that could interfere with pain perception or reporting.
  • •History of neuropathic pain in the amputated limb prior to the earthquake.
  • •Underwent surgical interventions in other parts of the body that may affect pain assessment.
  • •Inability to communicate effectively due to cognitive impairment or other medical conditions.

结局指标

主要结局

Prevalence of phantom limb pain

时间窗: 1 week, 3 months, 6 months, and 12 months

The percentage of amputee patients reporting PLP at each follow-up interval. PLP will be categorized as mild, moderate, or severe based on VAS scores.

o Prevalence of phantom limb sensations

时间窗: 1 week, 3 months, 6 months, and 12 months

The frequency of non-painful PLS such as tingling, itching, or movement sensations reported by patients at each follow-up period

次要结局

  • Incidence of residual limb pain(1 week, 3 months, 6 months, and 12 months)
  • o Impact of Analgesic Methods(1 week, 3 months, 6 months, and 12 months)

研究者

发起方
Mesut Bakır
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mesut Bakır

Clinical Professor

Mersin University

研究点 (1)

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