Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
NCT Number: NCT06798701
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Not applicable
Buffalo, New York, 14263, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Undergo standard care
Other names: standard of care, standard therapy
Ancillary studies
Ancillary studies
Use VR device
Other names: VR
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.
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.
Roswell Park Cancer Institute
Other
Symptom Management in the Bone Marrow Transplant Patient Population Using Virtual Reality
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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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