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

Not Applicable

Completed

• Conditions: Cancer
• Interventions: Behavioral: Virtual Reality Intervention

• Registration Number: NCT03103711
• Lead Sponsor: University of Valencia

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2017-03
• Study First Submitted: 2017-03-21
• Study First Submitted QC: 2017-03-31
• Last Update Submitted: 2017-03-31
• Study First Posted: 2017-04-06
• Last Update Posted: 2017-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Virtual Reality 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.

Primary Outcome Measures

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

Secondary Outcome Measures

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