Cancer and / or Hematological MalignancyNCT07145359
Virtual Reality Intervention for Symptom Management in Stem Cell Transplantation
A study testing Virtual Reality Intervention in people with Cancer and / or Hematological Malignancy and Hematopoetic Stem Cell Transplantation, run by Halic University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer and / or Hematological Malignancy, Hematopoetic Stem Cell Transplantation, Nursing Interventions
- What is being tested?
- Virtual Reality Intervention
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 10 Sep 2025to 10 Sep 2026
- 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
- 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
Who cannot join
- 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
About this study
Official title: Development and Evaluation of A Virtual Reality Intervention for Symptoms Management During Hematopoietic Stem Cell Transplantation
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:
Read more
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
Read the 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.
- Conditions
- Cancer and / or Hematological Malignancy, Hematopoetic Stem Cell Transplantation, Nursing Interventions, Symptom Management, Virtual Reality, ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION
- Being tested
- Virtual Reality Intervention
- Medical subject headings
- Neoplasms, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality InterventionOther
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, eligible patients are introduced to the intervention one day in advance and given the opportunity to trial the VR equipment, ask questions, and select their preferred video. During the infusion, VR is initiated exactly one minute before the stem cell procedure and ends at the 15th minute, as recommended by the literature. Symptom assessments are conducted immediately before and after the intervention using validated tools, including the Distress Thermometer, State Anxiety Inventory, and the Edmonto
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Participants in this group will receive standard clinical care during hematopoietic stem cell transplantation (HSCT) without any additional intervention. They will not be exposed to any virtual reality content during the procedure. This group serves as the comparator to evaluate the effects of the VR intervention. |
| Experimental group | Experimental | Participants in this group will receive standard clinical care during hematopoietic stem cell transplantation (HSCT) along with a 15-minute virtual reality (VR) intervention. The VR intervention involves viewing a nature-themed immersive video through a Meta Quest 3 headset. Patients will select one of five pre-approved videos created or curated by the research team based on Attention Restoration Theory (ART). The VR session will begin one minute before the stem cell infusion and end at the 15th minute of the procedure. The intervention is administered under the supervision of the researcher. Receives: Other: Virtual Reality Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Distress Level
Assessed using the Distress Thermometer. Scores range from 0 (no distress) to 10 (extreme distress).
Measured: From 15 minutes before HSCT infusion to 15 minutes after the start of infusion
Change in State Anxiety
Assessed using the State subscale of the State-Trait Anxiety Inventory (STAI).
Measured: From 15 minutes before HSCT infusion to 15 minutes after the start of infusion
Change in Symptom Severity
Evaluated using the Edmonton Symptom Assessment Scale (ESAS) including pain, fatigue, nausea, depression, anxiety, appetite loss, dyspnea, sleep disturbance, and overall well-being.
Measured: 15 minutes before HSCT infusion to 15 minutes after the start of infusion
Secondary outcomes (10)
Change in Systolic Blood Pressure
Change in systolic blood pressure (mmHg)
Measured: Baseline (pre-HSCT infusion), during HSCT infusion, and immediately post-infusion (within 30 minutes)
Change in Diastolic Blood Pressure
Change in diastolic blood pressure (mmHg)
Measured: Baseline (pre-HSCT infusion), during HSCT infusion, and immediately post-infusion (within 30 minutes)
Change in Heart Rate
Change in heart rate (beats per minute)
Measured: Baseline (pre-HSCT infusion), during HSCT infusion, and immediately post-infusion (within 30 minutes)
Change in Body Temperature
Change in body temperature (°C)
Measured: Baseline (pre-HSCT infusion), during HSCT infusion, and immediately post-infusion (within 30 minutes)
Change in Oxygen Saturation
Change in oxygen saturation (%)
Measured: Baseline (pre-HSCT infusion), during HSCT infusion, and immediately post-infusion (within 30 minutes)
Change in Respiratory Rate
Change in respiratory rate (breaths per minute)
Measured: Baseline (pre-HSCT infusion), during HSCT infusion, and immediately post-infusion (within 30 minutes)
Neutrophil Engraftment Time
Defined as the number of days from HSCT to the first of three consecutive days with absolute neutrophil count ≥500/mm³
Measured: Assessed on Day +28 post-transplant
Platelet Engraftment Time
Defined as the number of days from HSCT to the first of three consecutive days with platelet count ≥20,000/mm³ without transfusion
Measured: Assessed on Day +28 post-transplant
Patient Satisfaction (Visual Analog Scale)
Patient satisfaction will be assessed using the Visual Analog Scale (VAS; range 0-10 cm), where 0 = not satisfied at all (worst outcome) and 10 = extremely satisfied (best outcome). Higher scores indicate greater patient satisfaction.
Measured: Within 15 minutes after HSCT infusion
Patient Satisfaction (Qualitative Feedback Form)
Patient satisfaction with the virtual reality experience will be assessed using an open-ended feedback form. Patients will be invited to provide narrative responses addressing the following aspects:
Whether they were satisfied with the VR experience, Any side effects experienced (e.g., dizziness, nausea, discomfort), Suggestions for improvement.
Measured: Within 15 minutes after HSCT infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start10 Sep 2025 (estimated)
- Primary completion10 Jun 2026 (estimated)
- Study completion10 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer and / or Hematological MalignancyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Halic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07145359
- Sponsor's protocol ID
- 2025/350-361
- Status last verified
- Aug 2025
- First submitted
- 12 Aug 2025
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of A Virtual Reality Intervention for Symptoms Management During Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT07145359
- Acronym / sponsor ID
- 2025/350-361
- Conditions
- Cancer and / or Hematological Malignancy, Hematopoetic Stem Cell Transplantation, Nursing Interventions, Symptom Management, Virtual Reality, ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Halic UniversityUniversity, hospital or other
- Study start
- 10 Sep 2025 (estimated)
- Primary completion
- 10 Jun 2026 (estimated)
- Study completion
- 10 Sep 2026 (estimated)
- First posted
- 28 Aug 2025 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Participants in this group will receive standard clinical care during hematopoietic stem cell transplantation (HSCT) without any additional intervention. They will not be exposed to any virtual reality content during the procedure. This group serves as the comparator to evaluate the effects of the VR intervention. |
| Experimental group | Experimental | Other: Virtual Reality InterventionParticipants in this group will receive standard clinical care during hematopoietic stem cell transplantation (HSCT) along with a 15-minute virtual reality (VR) intervention. The VR intervention involves viewing a nature-themed immersive video through a Meta Quest 3 headset. Patients will select one of five pre-approved videos created or curated by the research team based on Attention Restoration Theory (ART). The VR session will begin one minute before the stem cell infusion and end at the 15th minute of the procedure. The intervention is administered under the supervision of the researcher. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Virtual Reality InterventionThis 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, eligible patients are introduced to the intervention one day in advance and given the opportunity to trial the VR equipment, ask questions, and select their preferred video. During the infusion, VR is initiated exactly one minute before the stem cell procedure and ends at the 15th minute, as recommended by the literature. Symptom assessments are conducted immediately before and after the intervention using validated tools, including the Distress Thermometer, State Anxiety Inventory, and the Edmonto | Other | Experimental group |
Primary outcome
Change in Distress Level
Time frame: From 15 minutes before HSCT infusion to 15 minutes after the start of infusion
Assessed using the Distress Thermometer. Scores range from 0 (no distress) to 10 (extreme distress).
Change in State Anxiety
Time frame: From 15 minutes before HSCT infusion to 15 minutes after the start of infusion
Assessed using the State subscale of the State-Trait Anxiety Inventory (STAI).
Change in Symptom Severity
Time frame: 15 minutes before HSCT infusion to 15 minutes after the start of infusion
Evaluated using the Edmonton Symptom Assessment Scale (ESAS) including pain, fatigue, nausea, depression, anxiety, appetite loss, dyspnea, sleep disturbance, and overall well-being.
10 secondary outcomes
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
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 28 Aug 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Intervention in people with Cancer and / or Hematological Malignancy and Hematopoetic Stem Cell Transplantation, run by Halic University.
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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Distress Level (time frame: From 15 minutes before HSCT infusion to 15 minutes after the start of infusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Aug 2025; AzTrials last refreshed its copy on 1 Nov 2026.