Promotion of Emotional Well-being in Hospitalized Cancer Patients by Virtual Reality

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to analyze the effect of a brief psychological intervention supported by Information and Communication Technologies, on the subjective well-being of hospitalized cancer patients. Participants are randomly assigned to one of 2 conditions: Intervention condition (4 Virtual reality sessions) and Control condition (waiting list control group).

Official Title
-----------------
A Brief Psychological Intervention Using Virtual Reality for the Promotion of Emotional Well-being in Hospitalized Cancer Patients

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Behavioral: Virtual Reality Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults with any cancer diagnosis hospitalized for at least 1 week Karnofsky functional state ≥50 life expectancy ≥2 months Exclusion Criteria: serious psychopathology cognitive impairment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>The entire intervention is composed by four 30 minutes sessions along 1 week. Its focus is on the promotion of well-being by the use of two virtual environments (Emotional Parks and Walk through Nature). These environments allow participants to involve in different exercises (working with self statements, videos, images, slow breathing, focus on the present exercises) with the purpose of increase positive emotional states. | Behavioral: Virtual Reality Intervention<br>* Participants receive two sessions oriented to joy and two focused on relax. In the first 2 sessions patients can choose the environment (Emotional Parks or Walk through Nature) and in the following ones participants visit the alternate environments.<br>|
| No Intervention: Control<br>Participants receive the medical treatment deliver by the hospital. They fulfill several questionnaires at two moments (pre and post 1 week after). After this, they have the possibility to receive the psychological intervention. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Hospital Anxiety and Depression Scale (HADS) (Zigmond & Snaith, 1983; adapted version of Tejero, Guimerá, Farré & Peri, 1986) |  | change from baseline at 1 week | 
| Fordyce Happiness Scale (Fordyce, 1988). |  | change from baseline at 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale: Mood. | Subjective mood change after each intervention session. | 4 days along 1 week | 
| Visual Analog Scale: Emotional State. Change from pre to post session. | Assessment of general mood, joy, sadness, anxiety, relax and vigor (7-point Likert scale) | 4 days along 1 week | 
| Visual Analog Scale: Physical Discomfort. Change from pre to post session. | Presence of pain, fatigue and physical discomfort (11-point Likert scale) | 4 days along 1 week | 
| Visual Analog Scale: Satisfaction with the Session Scale. | Level of pleasantness and perceived usefulness of each session (11-point Likert scale) | 4 days along 1 week | 
| Satisfaction with Intervention Scale (adapted version of Borkovec and Nau's, 1972) | Assesses satisfaction, recommendation, utility and discomfort (11-point Likert scale) | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Virtual reality, Well-being, Hospital