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

NCT03103711 | Completed

• 1 other identifier: ONCOTIC-I
• Study Type: interventional
• Target: 76
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Cancer

Keywords

Virtual reality; Well-being; Hospital

Outcome Measures

Primary Outcomes (2)

• The Hospital Anxiety and Depression Scale (HADS) (Zigmond & Snaith, 1983; adapted version of Tejero, Guimerá, Farré & Peri, 1986)

  change from baseline at 1 week

• Fordyce Happiness Scale (Fordyce, 1988).

  change from baseline at 1 week

Secondary Outcomes (5)

• Visual Analog Scale: Mood.

  4 days along 1 week

• Visual Analog Scale: Emotional State. Change from pre to post session.

  4 days along 1 week

• Visual Analog Scale: Physical Discomfort. Change from pre to post session.

  4 days along 1 week

• Visual Analog Scale: Satisfaction with the Session Scale.

  4 days along 1 week

• Satisfaction with Intervention Scale (adapted version of Borkovec and Nau's, 1972)

  1 week

Other Outcomes (4)

• The Brief Illness Perception Questionnaire (BIPQ) (Broadbent et al., 2006)

  baseline

• Personal meaning of the illness (ad-hoc).

  baseline

• Visual Analog Scale: Optimism

  baseline

Study Arms (2)

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.

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.

Interventions

Virtual Reality Intervention BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults with any cancer diagnosis
• hospitalized for at least 1 week
• Karnofsky functional state ≥50
• life expectancy ≥2 months

You may not qualify if:

• serious psychopathology
• cognitive impairment

Sponsors & Collaborators

• University of Valencia: lead
• Hospital Clínica Benidorm: collaborator
• Universitat Jaume I: collaborator
• Universitat Politècnica de València: collaborator

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: March 21, 2017
• First Posted: April 6, 2017
• Study Start: July 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: April 6, 2017

Record last verified: 2017-03