About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Virtual Reality Intervention
Other 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
Treatment groups
Trial outcomes
Primary outcomes
Change in Distress Level
Assessed using the Distress Thermometer. Scores range from 0 (no distress) to 10 (extreme distress).
Change in State Anxiety
Assessed using the State subscale of the State-Trait Anxiety Inventory (STAI).
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.
Secondary outcomes
Change in Systolic Blood Pressure
Change in systolic blood pressure (mmHg)
Change in Diastolic Blood Pressure
Change in diastolic blood pressure (mmHg)
Change in Heart Rate
Change in heart rate (beats per minute)
Change in Body Temperature
Change in body temperature (°C)
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: