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

Cancer Clinical Trial

Official title:

A Brief Psychological Intervention Using Virtual Reality for the Promotion of Emotional Well-being in Hospitalized Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03103711
• Other study ID #: ONCOTIC-I
• Status: Completed
• Phase: N/A
• First received: March 21, 2017
• Last updated: March 31, 2017
• Start date: July 2010
• Est. completion date: December 2011

Study information

• Verified date: March 2017
• Source: University of Valencia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Participants are randomly assigned to one of 2 conditions: Intervention condition (4 Virtual reality sessions) and Control condition (waiting list control group).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
University of Valencia	Hospital Clínica Benidorm, Universidad Politécnica de Valencia, Universitat Jaume I

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The Brief Illness Perception Questionnaire (BIPQ) (Broadbent et al., 2006)	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
Other	Personal meaning of the illness (ad-hoc).	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
Other	Visual Analog Scale: Optimism	11-point scale (not at all - completely)	baseline
Other	Visual Analog Scale: Life satisfaction	7-point scale (no satisfaction - completely satisfied)	baseline
Primary	The Hospital Anxiety and Depression Scale (HADS) (Zigmond & Snaith, 1983; adapted version of Tejero, Guimerá, Farré & Peri, 1986)		change from baseline at 1 week
Primary	Fordyce Happiness Scale (Fordyce, 1988).		change from baseline at 1 week
Secondary	Visual Analog Scale: Mood.	Subjective mood change after each intervention session.	4 days along 1 week
Secondary	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)	4 days along 1 week
Secondary	Visual Analog Scale: Physical Discomfort. Change from pre to post session.	Presence of pain, fatigue and physical discomfort (11-point Likert scale)	4 days along 1 week
Secondary	Visual Analog Scale: Satisfaction with the Session Scale.	Level of pleasantness and perceived usefulness of each session (11-point Likert scale)	4 days along 1 week
Secondary	Satisfaction with Intervention Scale (adapted version of Borkovec and Nau's, 1972)	Assesses satisfaction, recommendation, utility and discomfort (11-point Likert scale)	1 week