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Completed

NCT Number: NCT03103711

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

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).

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Collaborators

  • Hospital Clínica Benidorm
  • Universitat Jaume I
  • Universitat Politècnica de València

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Apr 6, 2017
Registry last updated
Apr 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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