Hematologic CancerNCT07894601
Virtual Reality Intervention to Improve Comfort in Hospitalized Hematology Patients
A study testing Immersive virtual reality experience in people with Hematologic Cancer, run by Fundación para la Investigación del Hospital Clínico de Valencia at 2 sites in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Cancer
- What is being tested?
- Immersive virtual reality experience
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 2 sitesSpain
- Study dates
- 26 Oct 2026to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Male and female patients, aged 18 or more and different racial backgrounds.
- Diagnosed with a hematological condition.
- Hospital stay of 15 days or longer to receive treatment for a diagnosed hematological malignancy.
Who cannot join
- Language barriers or physical and/or cognitive impairments that prevent patients from understanding the intervention or completing the study assessment tools.
- History of photosensitive epilepsy and/or intolerance to virtual reality.
- Failure to provide informed consent or withdrawal of informed consent.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites, 2 recruiting
- Recruiting
Instituto de Investigacion Sanitaria INCLIVA
Valencia, Valencia, 46010
Julia Carrió Fito RN, MSc, PhD(c), Nurse, +34667229297, julia.carrio@uv.es
- Recruiting
Consorcio Hospital General Universitario de Valencia
Valencia, Valencia, 46014
Julia Carrio Fito, +34667229297, julia.carrio@uv.es
About this study
Official title: An Open-Label, Multicenter, Randomized Controlled Trial to Evaluate the Effect of a Non-Pharmacological Virtual Reality Intervention on Comfort in Hospitalized Hematology Patients
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:
Read more
- Does the use of virtual reality devices improve the overall comfort of patients hospitalized with hematological malignancies?
- Does virtual reality improve patients' quality of life compared to standard clinical care without the use of this technology?
- What are the immediate effects of virtual reality on patient well-being, and what potential adverse effects may arise during its use?
- How do patients perceive the use of virtual reality during their hospital stay?
The researchers will compare two groups:
- Group A: Virtual reality intervention: Participants will use virtual reality devices for 15 minutes on days 5, 8, 15, and 22 of the study. They will be able to choose from a selection of virtual natural landscapes, providing an immersive distraction during their hospitalization.
- Group B: Control group: Participants will receive standard clinical care without the virtual reality intervention.
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.
Read the detailed description
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.
- Conditions
- Hematologic Cancer
- Being tested
- Immersive virtual reality experience
- Keywords
- Comfort, Hematologic Cancer, Hospitalization, Virtual Reality
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immersive virtual reality experienceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Other: Immersive virtual reality experience |
| Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 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.
Secondary outcomes (3)
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).
Measured: Atnday 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).
Measured: Before the intervention and immediately after the intervention at days 5, 8,15 and 22 of hospital admission.
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).
Measured: Immediately after the intervention at days 5, 8,15 and 22 of hospital admission.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start26 Oct 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hematologic CancerStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 145 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julia Carrió Fito, Fundación para la Investigación del Hospital Clínico de Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07894601
- Sponsor's protocol ID
- 2025/057
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gonzalez-Baz MD, Pacheco-Del Cerro E, Durango-Limarquez MI, Alcantarilla-Martin A, Romero-Arribas R, Ledesma-Fajardo J, Moro-Tejedor MN. The comfort perception in the critically ill patient from the Kolcaba theoretical model. Enferm Intensiva (Engl Ed). 2024 Oct-Dec;35(4):264-277. doi: 10.1016/j.enfie.2024.03.001. Epub 2024 Mar 27.
PubMed 38548548You WY, Yeh TP, Lee KC, Ma WF. A Preliminary Study of the Comfort in Patients with Leukemia Staying in a Positive Pressure Isolation Room. Int J Environ Res Public Health. 2020 May 22;17(10):3655. doi: 10.3390/ijerph17103655.
PubMed 32456113Zhang B, Jin X, Kuang X, Shen B, Qiu D, Peng J, Chen E, Dai X, Chen X, Wong CL. Effects of a Virtual Reality-Based Meditation Intervention on Anxiety and Depression Among Patients With Acute Leukemia During Induction Chemotherapy: A Randomized Controlled Trial. Cancer Nurs. 2023 Jan 23. doi: 10.1097/NCC.0000000000001206. Online ahead of print.
PubMed 36693237Amonoo HL, Newcomb R, Lorenz KA, Psenka R, Holmbeck K, Farnam EJ, Tse A, Desai S, Vassev N, Waldman LP, El-Jawahri A. A novel psychosocial virtual reality intervention (BMT-VR) for patients undergoing hematopoietic stem cell transplantation: Pilot randomized clinical trial design and methods. Contemp Clin Trials. 2024 Jul;142:107550. doi: 10.1016/j.cct.2024.107550. Epub 2024 Apr 27.
PubMed 38685401
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter, Randomized Controlled Trial to Evaluate the Effect of a Non-Pharmacological Virtual Reality Intervention on Comfort in Hospitalized Hematology Patients
- ClinicalTrials.gov ID
- NCT07894601
- Acronym / sponsor ID
- 2025/057
- Conditions
- Hematologic Cancer
- Keywords
- Comfort, Hematologic Cancer, Hospitalization, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 145 participants (estimated)
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de ValenciaUniversity, hospital or other
- Study start
- 26 Oct 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 26 Oct 2026 (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 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:
- Does the use of virtual reality devices improve the overall comfort of patients hospitalized with hematological malignancies?
- Does virtual reality improve patients' quality of life compared to standard clinical care without the use of this technology?
- What are the immediate effects of virtual reality on patient well-being, and what potential adverse effects may arise during its use?
- How do patients perceive the use of virtual reality during their hospital stay?
The researchers will compare two groups:
- Group A: Virtual reality intervention: Participants will use virtual reality devices for 15 minutes on days 5, 8, 15, and 22 of the study. They will be able to choose from a selection of virtual natural landscapes, providing an immersive distraction during their hospitalization.
- Group B: Control group: Participants will receive standard clinical care without the virtual reality intervention.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Immersive virtual reality experienceParticipants 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. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female patients, aged 18 or more and different racial backgrounds.
- Diagnosed with a hematological condition.
- Hospital stay of 15 days or longer to receive treatment for a diagnosed hematological malignancy.
Key exclusion criteria (3 listed)
- Language barriers or physical and/or cognitive impairments that prevent patients from understanding the intervention or completing the study assessment tools.
- History of photosensitive epilepsy and/or intolerance to virtual reality.
- Failure to provide informed consent or withdrawal of informed consent.
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 |
|---|---|---|
| Immersive virtual reality experienceThe 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. | Other | Intervention |
Primary outcome
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).
Time frame: At 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.
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.
3 secondary outcomes
To assess the quality of life of hospitalized hematology patients with EORTC QLQ-C30.
Time frame: Atnday 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.
Time frame: Before the intervention and immediately after the intervention at days 5, 8,15 and 22 of hospital admission.
Identify potential adverse effects when using the VR tool with "Simulator Sickness Questionnaire".
Time frame: Immediately after the intervention at days 5, 8,15 and 22 of hospital admission.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Background: PubMed 38548548Gonzalez-Baz MD, Pacheco-Del Cerro E, Durango-Limarquez MI, Alcantarilla-Martin A, Romero-Arribas R, Ledesma-Fajardo J, Moro-Tejedor MN. The comfort perception in the critically ill patient from the Kolcaba theoretical model. Enferm Intensiva (Engl Ed). 2024 Oct-Dec;35(4):264-277. doi: 10.1016/j.enfie.2024.03.001. Epub 2024 Mar 27.
- Background: PubMed 32456113You WY, Yeh TP, Lee KC, Ma WF. A Preliminary Study of the Comfort in Patients with Leukemia Staying in a Positive Pressure Isolation Room. Int J Environ Res Public Health. 2020 May 22;17(10):3655. doi: 10.3390/ijerph17103655.
- Background: PubMed 36693237Zhang B, Jin X, Kuang X, Shen B, Qiu D, Peng J, Chen E, Dai X, Chen X, Wong CL. Effects of a Virtual Reality-Based Meditation Intervention on Anxiety and Depression Among Patients With Acute Leukemia During Induction Chemotherapy: A Randomized Controlled Trial. Cancer Nurs. 2023 Jan 23. doi: 10.1097/NCC.0000000000001206. Online ahead of print.
- Background: PubMed 38685401Amonoo HL, Newcomb R, Lorenz KA, Psenka R, Holmbeck K, Farnam EJ, Tse A, Desai S, Vassev N, Waldman LP, El-Jawahri A. A novel psychosocial virtual reality intervention (BMT-VR) for patients undergoing hematopoietic stem cell transplantation: Pilot randomized clinical trial design and methods. Contemp Clin Trials. 2024 Jul;142:107550. doi: 10.1016/j.cct.2024.107550. Epub 2024 Apr 27.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immersive virtual reality experience in people with Hematologic Cancer, run by Fundación para la Investigación del Hospital Clínico de Valencia at 2 sites in Spain.
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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julia Carrió Fito RN, MSc, PhD(c), Nurse (+34667229297, julia.carrio@uv.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: At 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07894601, which also lists 4 linked publications.
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 2 Nov 2026.