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Evaluation of Lymphedema Patients Status During Covid-19 Pandemic

Evaluation of Lymphedema Patients Treatment Processes, Health Status, Coronavirus Phobia, Quality of Life, Anxiety and Depression During Covid-19 Pandemic

The pandemic, which started in China at the end of 2019, appeared in our country in a short time. Most hospitals and physicians were only concerned with the treatment of these patients. One of the most victimized patient groups in this duration was lymphedema patients who were in need of continuous follow-up and rehabilitation at necessary periods, but were also at risk in terms of covid-19 infection and could not go to hospitals unless necessary. The treatment of both primary and secondary lymphedema patients has been interrupted or delayed. This process has affected the health status, treatment processes and quality of life of the lymphedema patient group. The current situation may have caused them anxiety and depression as a result of infection fear. In this study, we aimed to evaluate the treatment processes, health status, coronavirus phobia, anxiety, and depression states of the lymphedema patients .

研究概览

地位

完全的

条件

详细说明

60 primary and secondary lymphedema male and female patients with stage I,II,III lymphedema older than 18 years old over who were followed up in the lymphedema outpatient clinic of the Physical Medicine and Rehabilitation Clinic were included in the study.They were called by phone. Permission was asked for questioning from the patients reached. A hundred lymphedema patients were called and 60 patients were reached or agreed to be interviewed. The questions on the form and scales were read clearly to the patients who accepted the interview and were asked to be answered by the patient. The health status of the admitted patients during the covid-19 pandemic period and the treatment processes were questioned with the form we prepared.These forms were included socio-demographic features, physical, and detailed medical histories.Edema staging was evaluated by the International Society of Lymphology (ISL) lymphedema staging classification.This information was filled in from patients' files. The pandemic process was evaluated in the other part of the form. Working status, mobilization during the pandemic process, whether he/she or his/her relative was diagnosed with coronavirus infection, whether he/she received suplemental treatment, how much he/she paid attention to hand-foot hygine, whether his/her swelling increased, whether he/she had a cellulite attack, whether he/she regular self-manual lymphatic drainage and/or exercise, It was questioned whether there was an increase in a different symptom other than swelling, eating habits and weight gain, most recently whether he used pressure stocking regularly.In addition, the fear because of the covid-19 virus was questioned with the coronavirus-19 phobia scale (CP19-S), quality of life with lymphedema quality of life arm / leg (LYMQOL), and anxiety and depression with the hospital anxiety and depression scale (HADS).

研究类型

观察性的

注册 (实际的)

60

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Ataşehir
      • Istanbul、Ataşehir、火鸡、34752
        • Fatih Sultan Mehmet Training and Research Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Primary or secondary lymphedema patients who aged over 18.

描述

Inclusion Criteria:

  • Primary or secondary lymphedema patients with stage I,II,II stage
  • Aged over 18 years old
  • Upper or lower extremity lymphedema

Exclusion Criteria:

  • Patients under the age of 18
  • Patients who do not accept phone calls.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:其他
  • 时间观点:横截面

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Coronavirus Phobia Scale
大体时间:1 day
The CP19-S has 20 items which is a self-report instrument with a five-point Likert-type scale to assess the levels of coronavirus (covid-19) phobia. All items are rated on a 5 point scale from "strongly disagree (1)" to "strongly agree (5)." The scores on the scale can range between 20 and 100 and a higher score indicates a greater phobia in the respected subscales (psychological, psycho-somatic, economic and social) and total scale. In the present study total scale scores ranged from 20 to 100 .
1 day
Lymphedema Quality of Life Arm
大体时间:1 day
The LYMQOL-Arm consists of four domains with 28 items. These domains are symptoms, appearance, function, and mood. The answers were evaluated on a four-point Likert scale (1= not at all 2= a little, 3= quite a bit, 4= a lot). Each item received a score between 1 and 4, with higher scores indicating a worse QOL. Domain totals were calculated by adding the individual scores and dividing the total by the number of questions answered (If >50% of questions per domain were not answered this cannot be calculated *and =0). If the item was not scored and left blank or not applicable, this was scored with a 0. The four domains and their corresponding questions are: Function 1 (a-h), 2,3, Appearance 4,5,6,7,8 Symptoms 9,10,11,12,13,14 and Emotion 15,16,17,18,19,20. Overall QOL (Q21) is scored as the value marked by the patient, between 0-10
1 day
Lymphedema Quality of Life Leg
大体时间:1 day
The LYMQOL-Leg consists of 27 items: 26 multiple-choice questions and 1 rating question. It covers four domains: symptoms, appearance, function, and mood. Scoring and calculating is same with the arm scale but differences are; function 1 (a-f), 2,3 appearance 4,5,6,7,8,9,10 symptoms 11,12,13,14,15 and emotion 16,17,18,19,20,21. Overall quality of life (Q22) is scored as the value marked by the patient, between 0-10.
1 day
Hospital Anxiety and Depression Scale
大体时间:1 day
It consists of 14 items with two subscales (seven items for anxiety and seven items for depression). Each item is scored 0-3. Each subscale is scored between 0 and 21. The aim of the scale is not to make a diagnosis, but to determine the risk group bt screening anxiety and depression in a short time in patients with physical diseases. The cut-off points of the Turkish version of the HADS were determined as 10 for the anxiety subscale and 7 for the depression subscale.
1 day

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Feyza Akan Begoğlu, MD、Fatih Sultan Mehmet Training and Research Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年6月1日

初级完成 (实际的)

2020年8月1日

研究完成 (实际的)

2020年8月1日

研究注册日期

首次提交

2020年9月25日

首先提交符合 QC 标准的

2020年9月25日

首次发布 (实际的)

2020年9月29日

研究记录更新

最后更新发布 (实际的)

2020年10月8日

上次提交的符合 QC 标准的更新

2020年10月5日

最后验证

2020年10月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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