Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03103711
Recruitment Status : Completed
First Posted : April 6, 2017
Last Update Posted : April 6, 2017
Sponsor:
Collaborators:
Hospital Clínica Benidorm
Universitat Jaume I
Universitat Politècnica de València
Information provided by (Responsible Party):
Rosa María Baños Rivera, 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).

Condition or disease Intervention/treatment Phase
Cancer Behavioral: Virtual Reality Intervention Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

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.



Primary Outcome Measures :
  1. 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 ]
  2. Fordyce Happiness Scale (Fordyce, 1988). [ Time Frame: change from baseline at 1 week ]

Secondary Outcome Measures :
  1. Visual Analog Scale: Mood. [ Time Frame: 4 days along 1 week ]
    Subjective mood change after each intervention session.

  2. 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)

  3. 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)

  4. 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)

  5. 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:
  1. 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).

  2. 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.

  3. Visual Analog Scale: Optimism [ Time Frame: baseline ]
    11-point scale (not at all - completely)

  4. Visual Analog Scale: Life satisfaction [ Time Frame: baseline ]
    7-point scale (no satisfaction - completely satisfied)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Layout table for additonal information
Responsible Party: Rosa María Baños Rivera, Full Professor, University of Valencia
ClinicalTrials.gov Identifier: NCT03103711    
Other Study ID Numbers: ONCOTIC-I
First Posted: April 6, 2017    Key Record Dates
Last Update Posted: April 6, 2017
Last Verified: March 2017

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rosa María Baños Rivera, University of Valencia:
Virtual reality
Well-being
Hospital