An interventional study of Immersive virtual reality experience in Hematologic Cancer, sponsored by Fundación para la Investigación del Hospital Clínico de Valencia. Not yet recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Fundación para la Investigación del Hospital Clínico de Valencia · Not applicable, Interventional, and Supportive care
The objective of this clinical trial is to determine whether virtual reality (VR) devices can improve comfort and quality of life in hospitalized adult patients with hematological malignancies who require at least 15 consecutive days of inpatient treatment. The study will include adult patients of both sexes with 18 years or more.
The main questions it aims to answer are:
The researchers will compare two groups:
Participants will be randomly assigned to one of the two groups. Comfort and quality of life will be assessed using the General Comfort Questionnaire (GCQ) and the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), both of which will be administered on days 5 and 22 of the study. Additionally, the immediate effects of virtual reality will be evaluated by measuring vital signs and assessing symptoms before and after the intervention, including any potential discomfort, dizziness, or nausea related to the use of this technology. The study aims to recruit approximately 145 participants across three hospitals in Valencia, Spain. The results could help determine whether virtual reality serves as a useful non-pharmacological nursing intervention for improving comfort and well-being during a prolonged hospital stay due to hematological malignancies.
A multicenter, parallel-group, randomized, open-label controlled clinical trial will be conducted at hospitals in Valencia, Spain. Approximately 145 participants will be recruited using convenience sampling and randomly assigned to either the intervention group or the control group by an individual external to the research team.
Participants in the intervention group will receive 15-minute virtual reality sessions on study days 5, 8, 15, and 22, using Meta Quest 3S headsets and the Brink Traveler application to explore virtual natural landscapes. Participants in the control group will receive usual clinical care without the virtual reality intervention.
Comfort and health-related quality of life will be assessed in both groups on study days 5 and 22 using the General Comfort Questionnaire (GCQ) and the EORTC QLQ-C30, respectively. In the intervention group, vital signs and symptoms will also be assessed before and after each virtual reality session to evaluate immediate effects and potential adverse effects, using the Simulator Sickness Questionnaire (SSQ) and the Edmonton Symptom Assessment System (ESAS).
Written informed consent will be obtained from all participants before enrollment. Recruitment and data collection are planned, with data collection expected to conclude in December 2028.
1,496 studies on the registry are indexed under Hematologic Neoplasms; 438 are open to participants now.
This study's planned enrollment of 145 is above the median of 45 across 1,090 interventional studies indexed under Hematologic Neoplasms.
Browse Hematologic Neoplasms studies →Fundación para la Investigación del Hospital Clínico de Valencia is the lead sponsor of 73 studies on the registry; 18 are open to participants now.
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Exclusion Criteria:
Participants assigned to the intervention group will receive 15-minute virtual reality sessions on study days 5, 8, 15, and 22 using Meta Quest 3S headsets and the Brink Traveler application to explore virtual natural landscapes. Sessions will be supervised by healthcare staff, with appropriate hygiene and asepsis measures. Comfort and health-related quality of life will be assessed on study days 5 and 22 using the General Comfort Questionnaire (GCQ) and the EORTC QLQ-C30, respectively. Vital signs and symptoms will also be assessed before and after each session to monitor immediate effects and potential adverse effects.
Other: Immersive virtual reality experience
Subjects in this arm do not receive any intervention beyond their routine clinical care. They are only required to complete questionnaires regarding comfort and quality of life on days 5 and 22 of their hospital stay.
The patient will undergo 4 virtual reality sessions using a Meta Quest 3S headset. They will view natural landscapes through the Brink Traveler application. An internal cleaning and asepsis protocol is used to ensure patient safety. In addition, the patient will be seated or lying in bed, accompanied by a healthcare professional participating in the study.
To determine the effectiveness of using VR headsets in improving the comfort of hematology patients during their hospital stay with the General Comfort Questionnaire (GCQ).
The GCQ consists of 48 items rated on a 4-point Likert scale, ranging from 1 (strongly disagree) to 4 (strongly agree). It includes 24 positively worded items and 24 negatively worded items, with the latter being reverse-scored. The questionnaire assesses comfort across four contexts (physical, psychospiritual, sociocultural, and environmental) and considers three types of comfort: relief, ease, and transcendence. It is designed for self-administration. The total score ranges from 48 to 192, with higher scores indicating greater comfort.
Time frame: At baseline (day 5 of hospital admission) and on day 22 of hospital admission. If the hospital stay is shorter than 22 days, the second assessment will be performed before hospital discharge.
To assess the quality of life of hospitalized hematology patients with EORTC QLQ-C30.
EORTC QLQ-C30 is a questionnaire on quality of life in cancer patients (widely used in clinical trials) comprising 5 functional domains (physical, role, emotional, cognitive, and social), 3 symptom domains (nausea and vomiting, pain, and fatigue), a global scale for physical health and quality of life, and, finally, 6 individual items that assess financial difficulties, diarrhea, constipation, loss of appetite, insomnia, and shortness of breath. The questionnaire is scored as follows: (1: not at all, 2: a little, 3: quite a bit, 4: very much), with two additional items rated on a scale from 1 (very poor) to 7 (excellent).
Time frame: At baseline (day 5 of hospital admission) and on day 22 of hospital admission. If the hospital stay is shorter than 22 days, the second assessment will be performed before hospital discharge.
Analyze immediate well-being when using VR headsets, using a visual analogue scale (VAS) and the "Edmonton Symptom Assessment System" questionnaire.
The VAS scale allows the patient to express their level of well-being, with 1 representing no well-being and 10 representing the highest level of well-being. Edmonton Symptom Assessment System: A scale that measures physical and psychological symptoms; it is widely used among cancer patients and has been validated in Spanish. It consists of 10 items to be rated, with scores ranging from 0 (no symptom) to 10 (the worst).
Time frame: Before the intervention and immediately after the intervention
Identify potential adverse effects when using the VR tool with "Simulator Sickness Questionnaire".
Simulator Sickness Questionnaire: original scale created by Kennedy et al. (1993) to measure the 16 potential effects of virtual reality, grouped into three dimensions (oculomotor, disorientation, and nausea), which has been translated into and validated for Spanish. Scores range from 0 (absent) to 3 (severe).
Time frame: Immediately after the intervention
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Fundación para la Investigación del Hospital Clínico de Valencia