Emotional Impact of the Way Conducting Cancer Patients to the Surgical Center: a Randomized Clinical Trial Comparing Transport by Stretcher on Wheels and Ambulation.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- Anxiety and depression levels
研究概览
简要总结
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.
详细描述
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Anxiety and depression levels
时间窗: 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
次要结局
未报告次要终点
研究者
Ricardo dos Reis
PhD
Barretos Cancer Hospital