CancerNCT03103711
Promotion of Emotional Well-being in Hospitalized Cancer Patients by Virtual Reality
A study testing Virtual Reality Intervention in people with Cancer, run by University of Valencia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Virtual Reality Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- Jul 2010to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults with any cancer diagnosis
- hospitalized for at least 1 week
- Karnofsky functional state ≥50
- life expectancy ≥2 months
Who cannot join
- serious psychopathology
- cognitive impairment
About this study
Official title: 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).
- Conditions
- Cancer
- Being tested
- Virtual Reality Intervention
- Keywords
- Virtual reality, Well-being, Hospital
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Behavioral: Virtual Reality Intervention |
| Control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
The Hospital Anxiety and Depression Scale (HADS) (Zigmond & Snaith, 1983; adapted version of Tejero, Guimerá, Farré & Peri, 1986)
Measured: change from baseline at 1 week
Fordyce Happiness Scale (Fordyce, 1988).
Measured: change from baseline at 1 week
Secondary outcomes (5)
Visual Analog Scale: Mood.
Subjective mood change after each intervention session.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2017
- Study startJul 2010
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Clínica Benidorm, Universitat Jaume I, Universitat Politècnica de València
- Responsible party
- Principal investigator, Rosa María Baños Rivera, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03103711
- Sponsor's protocol ID
- ONCOTIC-I
- Status last verified
- Mar 2017
- First submitted
- 21 Mar 2017
- Last updated
- 6 Apr 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Brief Psychological Intervention Using Virtual Reality for the Promotion of Emotional Well-being in Hospitalized Cancer Patients
- ClinicalTrials.gov ID
- NCT03103711
- Acronym / sponsor ID
- ONCOTIC-I
- Conditions
- Cancer
- Keywords
- Virtual reality, Well-being, Hospital
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Collaborators
- Hospital Clínica Benidorm, Universitat Jaume I, Universitat Politècnica de València
- Study start
- Jul 2010 (actual)
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 6 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Virtual Reality InterventionThe 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. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adults with any cancer diagnosis
- hospitalized for at least 1 week
- Karnofsky functional state ≥50
- life expectancy ≥2 months
Key exclusion criteria (2 listed)
- serious psychopathology
- cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality InterventionParticipants 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. | Behavioural | Intervention |
Primary outcome
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
5 secondary outcomes
Visual Analog Scale: Mood.
Time frame: 4 days along 1 week
Visual Analog Scale: Emotional State. Change from pre to post session.
Time frame: 4 days along 1 week
Visual Analog Scale: Physical Discomfort. Change from pre to post session.
Time frame: 4 days along 1 week
Visual Analog Scale: Satisfaction with the Session Scale.
Time frame: 4 days along 1 week
Satisfaction with Intervention Scale (adapted version of Borkovec and Nau's, 1972)
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Intervention in people with Cancer, run by University of Valencia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2017.