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Emotional Impact of the Way Conducting Cancer Patients to the Surgical Center

2021年8月31日 更新者:Ricardo dos Reis、Barretos Cancer Hospital

Emotional Impact of the Way Conducting Cancer Patients to the Surgical Center: a Randomized Clinical Trial Comparing Transport by Stretcher on Wheels and Ambulation.

Cancer is an extremely aggressive disease, anxiety and depression are consequences some patients may develop from diagnosis continuing during treatment. A measures control of the cancer is surgery for removal tumor. The surgical procedure is often a difficult experience for patients and their relatives, and patients in the preoperative period are often psychological symptoms of anxiety and depression. A previous study with the objective analyzing patient's emotional repercussion according the type of transport to the surgical center reached the following result: patients who go to the surgical center feel more relaxed in the preoperative period.

The primary objective is to analyze emotional repercussion of patient diagnosed with cancer classified in Eastern Cooperative Oncology Group (ECOG) Performance Status 0 and 1 according type transport to the surgical center.

研究概览

地位

完全的

条件

详细说明

A randomized clinical trial, prospective collection to be performed at the Barretos Cancer Hospital, will be include 176 patients, 88 patients being allocated to transport to operating room by stretcher on wheels (group 1) and 88 patients being allocated to transport to operating room by ambulation (group 2). Patients with indication elective surgery that meet the inclusion criteria will be included, and randomized for one of the groups, and may be referred by stretcher on wheels to the surgical center (group 1) or referred to the surgical center by ambulation (group 2). The Hospital Anxiety and Depression Scale (HAD) and the survey developed for the present study Sati-Cir, Evaluation Questionnaire of Satisfaction with Healthcare in Surgery, will be the instruments used in data collection. Participants will respond both after the course to the surgical center.

研究类型

观察性的

注册 (实际的)

176

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

    • SP
      • Barretos、SP、巴西、14784-400
        • Hospital do Cancer de Barretos

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

16年 至 68年 (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

概率样本

研究人群

The study population will be organized including 176 patients sheduled for elective cancer surgery at Barretos Cancer Hospital, 88 patients bei ng allocated for transporting to the operating room by stretcher on wheels, and 88 patients elective allocated for transporting to the operating room by ambulation.

描述

Inclusion Criteria:

  • diagnosed cancer
  • Age ≥18 years, ≤ 70 years
  • Both sexes
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score 0 or 1
  • Patients classified as Zero or Low Risk by the fall risk assessment scale
  • Indication elective surgery

Exclusion Criteria:

  • Patients who present moments before surgery has an adverse event that could jeopardize the ambulation to the surgical center.
  • Patients who are physically disabled and require assistance walking.
  • Patients has indication bed in the Intensive Care Unit (UTI)
  • Patients has previously diagnosed psychiatric disorders (severe depression, anxiety disorder, panic, among others).
  • Patients doens't have an accompanying person on the day of surgery.
  • Patients taking anxiolytic and antidepressant medications.

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:队列
  • 时间观点:预期

队列和干预

团体/队列
干预/治疗
Transport on foot
Patients go to operating room walking with their families and with their normal clothes
Patients go to operating room walking with their families and with their normal clothes
Transport by stretcher on wheels
Patients go to operating room by stretcher on wheels and with hospital clothes. Normal routine of our hospital.

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
Anxiety and depression levels
大体时间:up to 4 weeks
Measure the anxiety and depression levels using Hospital Anxiety and Depression Scale (HAD) and the survey developed for the present study Sati-Cir, Evaluation Questionnaire of Satisfaction with Healthcare in Surgery
up to 4 weeks

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:Gabriela da S Oliveira, Nurse、Barretos Cancer 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)

2019年1月7日

初级完成 (实际的)

2021年8月30日

研究完成 (实际的)

2021年8月30日

研究注册日期

首次提交

2018年6月13日

首先提交符合 QC 标准的

2018年6月22日

首次发布 (实际的)

2018年7月3日

研究记录更新

最后更新发布 (实际的)

2021年9月1日

上次提交的符合 QC 标准的更新

2021年8月31日

最后验证

2021年8月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 1527/2018

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

IPD 计划说明

We do not intend to share our individual participant data to other researches

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.

Transport on foot的临床试验

3
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