Loading search results
An Open-Label, Multicenter, Randomized Controlled Trial to Evaluate the Effect of a Non-Pharmacological Virtual Reality Intervention on Comfort in Hospitalized Hematology Patients
Sponsor study identifier
interventional
145
1 country
1
Study Start
October 26, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 19, 2026
Actual (reported)October 26, 2026
Actual (reported)October 26, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
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.
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.
Before the intervention and immediately after the intervention
Identify potential adverse effects when using the VR tool with "Simulator Sickness Questionnaire".
Immediately after the intervention
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.
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.
Instituto de Investigacion Sanitaria INCLIVA
Valencia, Valencia, 46010, Spain
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.
You 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.
First Submitted
October 19, 2026
First Posted
October 26, 2026
Study Start
October 26, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 31, 2028
Contact the study team to confirm eligibility.
Zhang 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.
Amonoo 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.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 29, 2026
Record last verified: 2026-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: