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Clinical Trial Summary

A prospective controlled randomized interventional study comparing the effects of the preoperative exposure to a virtual reality software versus not exposure in 126 patients with colorectal cancer. Patients will be divided in two randomized groups, each of them of 63 patients. The hypothesis of the study is that gradual exposure to the hospital environment using a virtual reality software is effective to reduce preoperative anxiety.

The main variable is the level of anxiety in patients undergoing colorectal cancer surgery. It will be measured using State-Trait Anxiety Inventory Scale (STAI-S) and the Hospital Anxiety and Depression Scale (HADS).


Clinical Trial Description

Colorectal cancer is the third most frequent neoplasia diagnosed worldwide, and in Spain it is the first in incidence and prevalence, accounting for 15% of all neoplasias according to World Health Organization (WHO).

The incidence of preoperative anxiety in patients undergoing elective surgery is high (60% - 76%). There are many causes for this: anticipation of postoperative pain, loss of independence, separation from the family, fear to the surgical procedure or to severe complications or even death. The incidence of preoperative anxiety varies according to age, sex, educational leve, previous exposure to surgical interventions and the expected impact of the surgical procedure in global quality of life.

Patients with anxiety require higher dosis of induction anesthesia, longer hospital stay, and a higher rate of perioperative complications due to a release of catecholamines, increase on the oxidative demands, causing tachycardia, arrhythmia, high blood pressure, etc.

Gradual exposition is considered an effective way of reducing anxiety. It has been demonstrated that anxiety is decreased in patients with history of surgical interventions, and thus the experience is experimented as an adaptive process. Virtual reality gives the opportunity to experience each of the steps of the hospital stay in a realistic environment.

The hypothesis of this study is that gradual exposure to the hospital environment using virtual reality is an effective tool to reduce preoperative anxiety in patients undergoing colorectal cancer surgery. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04058600
Study type Interventional
Source Hospital Clinic of Barcelona
Contact
Status Completed
Phase N/A
Start date April 11, 2018
Completion date February 12, 2020

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