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Active, Not Recruiting

NCT Number: NCT06798701

Virtual Reality for Symptom Management in Patients Undergoing Hematopoietic Stem Cell Transplantation

This clinical trial compares the use of virtual reality to standard care for improving symptom management in patients undergoing hematopoietic stem cell transplantation (HSCT). Significant symptoms experienced by hospitalized HSCT patients include, but are not limited to, depression, tiredness, anxiety, drowsiness, lack of appetite, pain, and overall decreased quality of life and well-being. Virtual reality (VR) as an intervention can provide these patients with a much-needed escape from their reality and has proven results in clinical settings as a distraction therapy. VR technology targets the patient's auditory, visual, and physical contact/touch senses, and has been evidenced to improve depression, fatigue, anxiety, appetite, and pain. Virtual reality may improve symptom management in patients undergoing HSCT.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

About this study

PRIMARY OBJECTIVE:

I. To determine the efficacy of VR for symptom management in the admitted HSCT patient population.

SECONDARY OBJECTIVE:

I. To examine the use of supportive medications for symptom management after HSCT while using VR.

EXPLORATORY OBJECTIVE:

I. To evaluate any limitations or barriers of the use of VR in the inpatient setting throughout the study.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients use the VR device to participate in applications related to relaxation such as mediation, art and nature, for up to 15 minutes, daily, while inpatient for standard of care HSCT.

ARM II: Patients undergo standard care for the HSCT.

After completion of study intervention, patients are followed up after discharge.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients (≥ 18 years old) admitted to Roswell Park on 5 North for planned hematopoietic stem cell transplantation (HSCT)
  • Must be alert and oriented (Glascow Coma Scale of 15, Nursing Universal Flowsheet) and able to consent to participate in the study
  • Expected to be admitted to Roswell Park inpatient unit for ≥ 1 week
  • Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion criteria

  • Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant patients
  • Incarcerated patients
  • Patients who are unwilling or unable to follow protocol requirements
  • Individuals that are prone to motion sickness, nausea, dizziness, history of seizure, potential for seizure, history of delirium, at risk for confusion, etc
  • Participants with audio and/or visual impairments that would preclude them from using a VR device

Treatment and study plan

Best Practice

Other

Undergo standard care

Other names: standard of care, standard therapy

interview

Other

Ancillary studies

Survey Administration

Other

Ancillary studies

Virtual Reality

Procedure

Use VR device

Other names: VR

Primary outcomes

  1. Difference in the trajectories of the mean Edmonston Symptom Assessment System Revised (ESAS-r) composite scores

    Time frame: Length of hospital stay up to 6 months

    Firstly, the pattern of ESAS-r scores over time will be graphically examined. To account for the within-individual correlations, a generalized linear mixed model with appropriate link function will be applied. The time is measured by the number of days after treatment start and will be considered as a continuous variable. The effect of interest is the time by group interaction. Significant interaction implies different trajectories of ESAS-r composite scores over time. If the nonlinear patterns were observed, appropriate transformation or analyses focusing on the linear region will be considered. All tests will be two sided at a significant level of 0.05. Scores of individual items will be compared using the same approach. False discovery rate will be controlled using Benjamini-Hochberg procedure. As complementary analyses, models with only surveys before or after the virtual reality will also be examined.

Secondary outcomes

  1. Counts of supportive medication administration

    Time frame: Length of hospital stay up to 6 months

    Will be compared between two arms using generalized linear mixed models with appropriate link functions. The types of medications will be summarized by counts and percentages for each arm. Pre-intervention counts will be compared to during-intervention counts. The types of supportive medications will also be examined (i.e. anxiolytic, antidepressant, analgesic or antiemetics). Medications include (but are not limited to) the following: hydromorphone, acetaminophen, lorazepam, ondansetron, prochlorperazine, trazodone, and tramadol.

Sponsors and collaborators

Lead sponsor

Roswell Park Cancer Institute

Other

Registry information

Official study title

Symptom Management in the Bone Marrow Transplant Patient Population Using Virtual Reality

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jan 29, 2025
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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