Behaviors and Mental Disorders

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Colorectal Neoplasms

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Digestive System Neoplasms

Gastrointestinal Diseases

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Rectal Diseases

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.

Patients in this group are not exposed preoperatively to the virtual reality software and are given the standard therapy and cares for their disease.

Patients will be exposed to a virtual reality software that simulates the hospital environment, from admission to the operating room and the recovery room.

Virtual Reality Software

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).

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.

Single center prospective randomized two arms study

Exposure to Virtual Reality as Psychosocial Intervention in Colorectal Cancer Surgery

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

Individual participant data (IPD) data will not be available to other researchers. The study protocol and the global data will be available in the written paper.

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.

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.

Hospital Clinic of Barcelona

Chief of Gastrointestinal Surgery Department

Skin and Connective Tissue Diseases

Breast Neoplasms

Pelvic Neoplasms

Virtual reality session performed before the planning CT scan

The patient will undergo a 20-minute virtual reality session before the planning CT scan

Virtual reality software

Agnès Dorion

Cédric ALANET

In France, according to the National Cancer Institute, it appears that treatments in radiotherapy centers for cancer will increase from 198,000 in 2015 to 239,000 in 2030: this represents 40,000 additional treatments in 15 years.

A meta-analysis on radiotherapy indicated that 10 to 20% of patients had clinically significant levels of anxiety at the beginning of radiotherapy.

Indeed, several factors generate this tension, above all the new or unfamiliar environment, the imposing and noisy scanner, the restraints that are difficult to bear or the nudity required for the examination.

This anxiety has an impact on performance of the planning CT scan examination, an essential step for the future treatment.

The radiotherapy unit of the Centre Hospitalier Departemental de Vendee has put in place resources to reduce anxiety felt during treatment sessions (music therapy, conversational hypnosis, sophrology or aromatherapy). However, nothing has been put in place to reduce the anxiety of patients in the period preceding the planning CT scan.

Virtual reality software seems to be a good alternative that requires fewer human resources.

The research hypothesis is that patients who have benefited from the virtual reality software will have a lower level of anxiety before the planning CT scan than patients who have not benefited from virtual reality.

Interest of Virtual Reality on Anxiety Before the Planning CT Scan in Radiotherapy

Anxiety level measured by the State Anxiety Scale of Spielberger. The scale is a validated 20 item self report assessment device. The score range is 20-80, the higher score indicating anxiety. The cut point of 39-40 has been suggested to detect clinically significant symptoms for the State Anxiety scale.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Exposure to Virtual Reality as Psychosocial Intervention in Colorectal Cancer Surgery	NCT04058600	Anxiety Colorectal Canc...	Virtual Reality...	18 Years - 99 Years	Hospital Clinic of Barcelona
Interest of Virtual Reality on Anxiety Before the Planning CT Scan in Radiotherapy	NCT05269186	Breast Cancer Pelvic Cancer	Virtual reality...	18 Years - 84 Years	Centre Hospitalier Departemental Vendee

Spots Global Cancer Trial Database for virtual reality software