Virtual Reality Intervention for Symptom Management in Stem Cell Transplantation

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHalic University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Virtual Reality Intervention

    Other 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, 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

30 Participants
are divided into 2 treatment groups
Group A: Control groupNo intervention 0 interventions
Group B: Experimental groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in Distress Level

Assessed using the Distress Thermometer. Scores range from 0 (no distress) to 10 (extreme distress).

Time frame
From 15 minutes before HSCT infusion to 15 minutes after the start of infusion
2

Change in State Anxiety

Assessed using the State subscale of the State-Trait Anxiety Inventory (STAI).

Time frame
From 15 minutes before HSCT infusion to 15 minutes after the start of infusion
3

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.

Time frame
15 minutes before HSCT infusion to 15 minutes after the start of infusion

Secondary outcomes

1

Change in Systolic Blood Pressure

Change in systolic blood pressure (mmHg)

Time frame
Baseline (pre-HSCT infusion), during HSCT infusion, and immediately post-infusion (within 30 minutes)
2

Change in Diastolic Blood Pressure

Change in diastolic blood pressure (mmHg)

Time frame
Baseline (pre-HSCT infusion), during HSCT infusion, and immediately post-infusion (within 30 minutes)
3

Change in Heart Rate

Change in heart rate (beats per minute)

Time frame
Baseline (pre-HSCT infusion), during HSCT infusion, and immediately post-infusion (within 30 minutes)
4

Change in Body Temperature

Change in body temperature (°C)

Time frame
Baseline (pre-HSCT infusion), during HSCT infusion, and immediately post-infusion (within 30 minutes)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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