Skip to main content
Clinical Trials/NCT03576482
NCT03576482
Completed
Not Applicable

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

Barretos Cancer Hospital1 site in 1 country176 target enrollmentJanuary 7, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anxiety Disorders
Sponsor
Barretos Cancer Hospital
Enrollment
176
Locations
1
Primary Endpoint
Anxiety and depression levels
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
January 7, 2019
End Date
August 30, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Barretos Cancer Hospital
Responsible Party
Principal Investigator
Principal Investigator

Ricardo dos Reis

PhD

Barretos Cancer Hospital

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Anxiety and depression levels

Time Frame: 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

Study Sites (1)

Loading locations...

Similar Trials