Clinical trial NCT04058600: Exposure to Virtual Reality as Psychosocial Intervention in Colorectal Cancer Surgery
Official title: Exposure to Virtual Reality as Psychosocial Intervention in Colorectal Cancer Surgery in Hospital Clinic of Barcelona, Spain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Colorectal Cancer
Keywords: virtual reality (VR)
anxiety
colorectal cancer
surgery
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2019-08-15
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single center prospective randomized two arms study
Primary purpose: PREVENTION

Brief 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).

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: 1 day prior to surgical intervention
measure: Hospital Anxiety and Depression Scale (HAD)
timeFrame: 1 day prior to surgical intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Victor Turrado-Rodriguez
Study officials:
References:
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