Promotion of Emotional Well-being in Hospitalized Cancer Patients by Virtual Reality
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|ClinicalTrials.gov Identifier: NCT03103711|
Recruitment Status : Completed
First Posted : April 6, 2017
Last Update Posted : April 6, 2017
University of Valencia
Hospital Clínica Benidorm
Universitat Jaume I
Universitat Politècnica de València
Information provided by (Responsible Party):
Rosa María Baños Rivera, University of Valencia
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).
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Behavioral: Virtual Reality Intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||76 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Brief Psychological Intervention Using Virtual Reality for the Promotion of Emotional Well-being in Hospitalized Cancer Patients|
|Actual Study Start Date :||July 2010|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2011|
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.
Primary Outcome Measures :
- The Hospital Anxiety and Depression Scale (HADS) (Zigmond & Snaith, 1983; adapted version of Tejero, Guimerá, Farré & Peri, 1986) [ Time Frame: change from baseline at 1 week ]
- Fordyce Happiness Scale (Fordyce, 1988). [ Time Frame: change from baseline at 1 week ]
Secondary Outcome Measures :
- Visual Analog Scale: Mood. [ Time Frame: 4 days along 1 week ]Subjective mood change after each intervention session.
- Visual Analog Scale: Emotional State. Change from pre to post session. [ Time Frame: 4 days along 1 week ]Assessment of general mood, joy, sadness, anxiety, relax and vigor (7-point Likert scale)
- Visual Analog Scale: Physical Discomfort. Change from pre to post session. [ Time Frame: 4 days along 1 week ]Presence of pain, fatigue and physical discomfort (11-point Likert scale)
- Visual Analog Scale: Satisfaction with the Session Scale. [ Time Frame: 4 days along 1 week ]Level of pleasantness and perceived usefulness of each session (11-point Likert scale)
- Satisfaction with Intervention Scale (adapted version of Borkovec and Nau's, 1972) [ Time Frame: 1 week ]Assesses satisfaction, recommendation, utility and discomfort (11-point Likert scale)
Other Outcome Measures:
- The Brief Illness Perception Questionnaire (BIPQ) (Broadbent et al., 2006) [ Time Frame: baseline ]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).
- Personal meaning of the illness (ad-hoc). [ Time Frame: baseline ]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.
- Visual Analog Scale: Optimism [ Time Frame: baseline ]11-point scale (not at all - completely)
- Visual Analog Scale: Life satisfaction [ Time Frame: baseline ]7-point scale (no satisfaction - completely satisfied)
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