Development and Evaluation of A Virtual Reality Intervention for Symptoms Management During Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Change in Distress Level
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Control group
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
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.
干预措施: Virtual Reality Intervention (Other)
结局指标
主要结局
Change in Distress Level
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Change in Systolic Blood Pressure(Baseline (pre-HSCT infusion), during HSCT infusion, and immediately post-infusion (within 30 minutes))
- Change in Diastolic Blood Pressure(Baseline (pre-HSCT infusion), during HSCT infusion, and immediately post-infusion (within 30 minutes))
- Change in Heart Rate(Baseline (pre-HSCT infusion), during HSCT infusion, and immediately post-infusion (within 30 minutes))
- Change in Body Temperature(Baseline (pre-HSCT infusion), during HSCT infusion, and immediately post-infusion (within 30 minutes))
- Change in Oxygen Saturation(Baseline (pre-HSCT infusion), during HSCT infusion, and immediately post-infusion (within 30 minutes))
- Change in Respiratory Rate(Baseline (pre-HSCT infusion), during HSCT infusion, and immediately post-infusion (within 30 minutes))
- Neutrophil Engraftment Time(Assessed on Day +28 post-transplant)
- Platelet Engraftment Time(Assessed on Day +28 post-transplant)
- Patient Satisfaction (Visual Analog Scale)(Within 15 minutes after HSCT infusion)
- Patient Satisfaction (Qualitative Feedback Form)(Within 15 minutes after HSCT infusion)