Virtual Reality Intervention for Symptom Management in Stem Cell Transplantation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Virtual Reality Intervention.
- Who it may be relevant to
- Registry conditions: Cancer and / or Hematological Malignancy, Hematopoetic Stem Cell Transplantation, Nursing Interventions, Symptom Management. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Development and Evaluation of A Virtual Reality Intervention for Symptoms Management During Hematopoietic Stem Cell Transplantation
Overview
The goal of this clinical trial is to evaluate whether a virtual reality (VR) intervention based on the Symptom Management Model can reduce physical and psychosocial symptoms during hematopoietic stem cell transplantation (HSCT) in adult patients undergoing allogeneic transplantation. The main questions it aims to answer are: Does the VR intervention reduce distress levels during HSCT? Does the VR intervention decrease state anxiety and symptom severity compared to standard care? Does the VR intervention positively affect physiological outcomes and engraftment times? Researchers will compare a group receiving standard clinical care plus a VR nature-themed video during HSCT to a group receiving standard care only to see if the VR intervention improves symptom management outcomes. Participants will: Be randomly assigned to either the intervention or control group. In the intervention group: Watch a 15-minute nature-themed VR video during stem cell infusion using Meta Quest 3. The video content will be specifically created by the research team based on the principles of Attention Restoration Theory (ART). In both groups: Complete pre- and post-intervention assessments including: Distress Thermometer State-Trait Anxiety Inventory Edmonton Symptom Assessment Scale Physiological measures (vital signs) Engraftment tracking Satisfaction and open-ended feedback forms
Detailed description
This study is a randomized controlled pilot trial designed to evaluate the effectiveness of a virtual reality (VR) intervention, based on the Symptom Management Model (SYM), in managing physical and psychosocial symptoms during allogeneic hematopoietic stem cell transplantation (HSCT). The intervention is nurse-led and grounded in Attention Restoration Theory (ART), utilizing immersive 360° nature-themed videos created or selected by the research team. These videos are intended to support psychological relaxation, reduce distress, and shift patients' focus away from treatment-related discomfort.
Eligible participants will be adult patients scheduled for allogeneic HSCT using peripheral blood stem cells. Patients will be randomly assigned to either the intervention or control group using stratified block randomization. The intervention group will receive standard clinical care in addition to watching a 15-minute VR video during the stem cell infusion procedure, delivered via Meta Quest 3 headsets. The control group will receive standard care only.
One day before the HSCT procedure, the researcher will meet with the eligible patients to introduce the study, answer questions, and familiarize them with the VR equipment and video content. Patients in the intervention group will be allowed to choose one of five pre-approved nature-themed VR videos. On the day of transplantation, baseline data (distress, anxiety, symptoms, vitals) will be collected approximately 15 minutes before the procedure. The VR headset will be applied 3 minutes before the infusion begins, and the video will start 1 minute prior to the procedure. The infusion will proceed according to the institution's standard protocols. Vital signs will be recorded during the intervention by the researcher. Patients will be reminded that they can request to remove the headset at any point if they feel uncomfortable.
At the 15th minute of the HSCT infusion, the video will end. Post-intervention assessments will include distress, anxiety, symptom severity, and satisfaction. If the patient does not feel well enough immediately after the session, additional time will be provided before collecting post-test data. To prevent infection risks, VR equipment will be disinfected after each use.
In addition to psychological and symptomatic outcomes, physiological parameters (blood pressure, heart rate, body temperature, oxygen saturation, respiratory rate) will be tracked. Neutrophil and platelet engraftment status will be assessed on Day +28 post-transplant. Patient satisfaction with the intervention will be measured using a visual analog scale and open-ended feedback.
This is the first known Turkish study to implement a theory-based, nurse-led virtual reality intervention during HSCT with the goal of symptom management. It is expected to provide valuable insight into the integration of digital care tools in supportive oncology nursing practice.
Interventions
- Other Virtual Reality Intervention
This intervention is distinguished by its integration of a structured, nurse-led virtual reality (VR) protocol specifically designed for symptom management during hematopoietic stem cell transplantation (HSCT). Unlike general VR distraction methods used in oncology, this intervention employs video content created by the research team in accordance with Attention Restoration Theory (ART), offering five preselected nature-themed options tailored to patient preferences. Prior to the procedure, elig
Primary outcome measures
- Change in Distress Level [Time frame: From 15 minutes before HSCT infusion to 15 minutes after the start of infusion]
- Change in State Anxiety [Time frame: From 15 minutes before HSCT infusion to 15 minutes after the start of infusion]
- Change in Symptom Severity [Time frame: 15 minutes before HSCT infusion to 15 minutes after the start of infusion]
Secondary outcome measures (10)
- Change in Systolic Blood Pressure [Time frame: Baseline (pre-HSCT infusion), during HSCT infusion, and immediately post-infusion (within 30 minutes)]
- Change in Diastolic Blood Pressure [Time frame: Baseline (pre-HSCT infusion), during HSCT infusion, and immediately post-infusion (within 30 minutes)]
- Change in Heart Rate [Time frame: Baseline (pre-HSCT infusion), during HSCT infusion, and immediately post-infusion (within 30 minutes)]
- Change in Body Temperature [Time frame: Baseline (pre-HSCT infusion), during HSCT infusion, and immediately post-infusion (within 30 minutes)]
- Change in Oxygen Saturation [Time frame: Baseline (pre-HSCT infusion), during HSCT infusion, and immediately post-infusion (within 30 minutes)]
- Change in Respiratory Rate [Time frame: Baseline (pre-HSCT infusion), during HSCT infusion, and immediately post-infusion (within 30 minutes)]
- Neutrophil Engraftment Time [Time frame: Assessed on Day +28 post-transplant]
- Platelet Engraftment Time [Time frame: Assessed on Day +28 post-transplant]
- Patient Satisfaction (Visual Analog Scale) [Time frame: Within 15 minutes after HSCT infusion]
- Patient Satisfaction (Qualitative Feedback Form) [Time frame: Within 15 minutes after HSCT infusion]
Eligibility criteria
Inclusion criteria
- Patients aged 18 years or older
- Able to speak and understand Turkish
- Scheduled to undergo allogeneic hematopoietic stem cell transplantation (HSCT)
- Receiving stem cell products collected from peripheral blood
- Voluntarily agree to participate in the study and provide informed consent
Exclusion criteria
- Undergoing autologous hematopoietic stem cell transplantation
- Receiving stem cell products collected from bone marrow
- Diagnosed with medical or psychiatric comorbidities that could interfere with participation, as reported by the healthcare team
- Presenting infection symptoms (e.g., respiratory, gastrointestinal) that may contaminate study equipment, as identified by the healthcare team
- Having visual, auditory, verbal, or cognitive impairments that may prevent interaction with the VR equipment
- Previously received any form of hematopoietic stem cell transplantation
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07145359 · 2025/350-361