Exposure to Virtual Reality as Psychosocial Intervention in Colorectal Cancer Surgery

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Exposure to Virtual Reality as Psychosocial Intervention in Colorectal Cancer Surgery in Hospital Clinic of Barcelona, Spain

Conditions
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Anxiety, Colorectal Cancer

Intervention / Treatment
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* Behavioral: Virtual Reality Software


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed of colorectal cancer requiring elective surgery. American Society of Anesthesiologists (ASA) I - III. No surgical history. Surgical procedure programmed in the next 6 months. Exclusion Criteria: Neurologic deficits. Visual disorder. Neuro-psychiatric disorder. Use of neuro-psychiatric drugs. Non-sphincter-preserving surgery.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single center prospective randomized two arms study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Reality<br>The patients will be exposed to a virtual reality software that simulates the environment of the hospital, from admission to the operating room and the recovery room. | Behavioral: Virtual Reality Software<br>* Patients will be exposed to a virtual reality software that simulates the hospital environment, from admission to the operating room and the recovery room.<br>|
| No Intervention: Control<br>Patients in this group are not exposed preoperatively to the virtual reality software and are given the standard therapy and cares for their disease. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| State-Trait Anxiety Inventory (STAI) | Change from Baseline Anxiety STAI scale to STAI scale the day previous to the surgery. Range of scores for each subtest is 20-80, the higher score indicating greater anxiety. | 1 day prior to surgical intervention | 
| Hospital Anxiety and Depression Scale (HAD) | Change from Baseline Anxiety HAD to HAD scale the day previous to the surgery. The total score for the HADS-A can range from 0 to 21. The following guidelines are recommended for the interpretation of scores: 0-7 for normal or no anxiety, 8-10 for mild anxiety, 11-14 for moderate anxiety, and 12-21 for severe anxiety. | 1 day prior to surgical intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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virtual reality (VR), anxiety, colorectal cancer, surgery