Virtual Reality Intervention for Symptom Management in Stem Cell Transplantation

NCT07145359 | Not Yet Recruiting DMC

• 1 other identifier: 2025/350-361
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Conditions

Cancer and / or Hematological Malignancy; Hematopoetic Stem Cell Transplantation; Nursing Interventions; Symptom Management; Virtual Reality; ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION

Outcome Measures

Primary Outcomes (3)

• Change in Distress Level

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

  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).

  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.

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

Secondary Outcomes (10)

• 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)

Study Arms (2)

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.

Other: Virtual Reality Intervention

Interventions

Virtual Reality Intervention OTHER

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

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Halic University: lead

MeSH Terms

Conditions

Neoplasms; Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: August 28, 2025
• Study Start: September 10, 2025
• Primary Completion: June 10, 2026
• Study Completion (Estimated): September 10, 2026
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share