- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03103711
Promotion of Emotional Well-being in Hospitalized Cancer Patients by Virtual Reality
March 31, 2017 updated by: Rosa María Baños Rivera, University of Valencia
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
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
76
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
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.
|
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)
Time Frame: change from baseline at 1 week
|
change from baseline at 1 week
|
Fordyce Happiness Scale (Fordyce, 1988).
Time Frame: change from baseline at 1 week
|
change from baseline at 1 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analog Scale: Mood.
Time Frame: 4 days along 1 week
|
Subjective mood change after each intervention session.
|
4 days along 1 week
|
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)
|
4 days along 1 week
|
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 days along 1 week
|
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)
|
4 days along 1 week
|
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)
|
1 week
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
baseline
|
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.
|
baseline
|
Visual Analog Scale: Optimism
Time Frame: baseline
|
11-point scale (not at all - completely)
|
baseline
|
Visual Analog Scale: Life satisfaction
Time Frame: baseline
|
7-point scale (no satisfaction - completely satisfied)
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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