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

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

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).

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Behavioral: Virtual Reality Intervention

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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; 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.
No Intervention: Control; 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	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Brief Illness Perception Questionnaire (BIPQ) (Broadbent et al., 2006)	This instrument has 9 items aimed to evaluate the cognitive and emotional representation of the illness (consequences, timeline, personal control, treatment control, identity, concern, emotional response, illness coherence and causes).	baseline
Personal meaning of the illness (ad-hoc).	Patient has 6 alternatives of illness meaning (Loss, threat, challenge, blame-others, blame-self and opportunity). In addition to these alternatives, participant can add any other personal meaning.	baseline
Visual Analog Scale: Optimism	11-point scale (not at all - completely)	baseline
Visual Analog Scale: Life satisfaction	7-point scale (no satisfaction - completely satisfied)	baseline

Collaborators and Investigators

• Sponsor: University of Valencia
• Collaborators: Universitat Jaume I; Universitat Politècnica de València; Hospital Clínica Benidorm

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2010
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: March 21, 2017
• First Submitted That Met QC Criteria: March 31, 2017
• First Posted (Actual): April 6, 2017

Study Record Updates

• Last Update Posted (Actual): April 6, 2017
• Last Update Submitted That Met QC Criteria: March 31, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Hospital; Well-being; Virtual reality
• Other Study ID Numbers: ONCOTIC-I

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No