University of Arizona
Tucson, Arizona, 85719, United States
Location contact
Michele Chu-Pilli
CONTACT
Renee Miu, DO
CONTACT
Renee Miu, DO
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07649512
Patients planned for cellular therapy supplementation such as CAR-T or stem cell transplant who are admitted for atleast 7 days in patient. During that time of admission, patients enrolled will complete a once daily, virtual reality guided progressive muscle relaxation program. Various validated QOL tools will be utilized to assess study results.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Tucson, Arizona, 85719, United States
Michele Chu-Pilli
CONTACT
Renee Miu, DO
CONTACT
Renee Miu, DO
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will utilize VR headset in the intervention arm. This headset will be pre-populated with PMR guided meditation videos.
Time frame: Enrollment through completion of the 7-day intervention period.
Feasibility will be assessed using three operational metrics:
Recruitment rate - the proportion of eligible patients who consent to participate in the study.
Retention rate - the proportion of enrolled participants who complete the 7-day intervention period.
Adherence rate - the proportion of participants who complete at least 5 VR-guided PMR sessions lasting up to 20 minutes each during the first 7 days of hospitalization.
These outcomes will be summarized descriptively as proportions and percentages among enrolled participants.
Time frame: Baseline (Day 1) through Day 7 following enrollment.
The Edmonton Symptom Assessment System-Revised (ESAS-r) is a validated patient-reported symptom assessment tool used to measure common physical and psychological symptoms in patients with cancer. The ESAS-r assesses nine symptoms (pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being, and shortness of breath) using a numeric rating scale from 0 to 10 for each symptom, where 0 indicates no symptom and 10 indicates the worst possible symptom severity. Changes in individual symptom scores and total symptom burden will be summarized descriptively from baseline to Day 7 following the intervention.
Time frame: Baseline (Day 1) through Day 7 following enrollment.
The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) is a validated patient-reported instrument used to assess health-related quality of life in patients with cancer. The questionnaire contains 30 items assessing global health status, functional domains (physical, role, cognitive, emotional, and social functioning), and symptom domains. Scores are transformed to a 0-100 scale according to the EORTC scoring manual.
For the global health status and functional scales, higher scores indicate better quality of life and functioning, whereas for the symptom scales, higher scores indicate greater symptom burden. Changes in global health status and symptom scores from baseline to Day 7 will be summarized descriptively.
Time frame: Baseline (Day 1) through Day 7 following enrollment.
Perceived muscle tension and relaxation will be assessed using a Visual Analog Scale (VAS). Participants will rate their perceived level of muscle tension and relaxation on a numeric scale from 0 to 10, where 0 represents no tension/complete relaxation and 10 represents the highest level of tension or discomfort. Scores will be recorded before and after progressive muscle relaxation (PMR) sessions, and changes in VAS scores over the 7-day intervention period will be summarized descriptively.
Time frame: Day 7 following enrollment or hospital discharge if earlier.
Participant acceptability of the intervention will be assessed using a brief post-intervention acceptability survey administered at Day 7 (or discharge if earlier). Participants will rate overall satisfaction, usability, comfort, and willingness to use the VR-guided progressive muscle relaxation intervention again using 5-point Likert scale responses ranging from 1 to 5, where 1 indicates very dissatisfied and 5 indicates very satisfied. Higher scores indicate greater satisfaction and acceptability of the intervention. Responses will be summarized descriptively.
Contact information is provided by the study sponsor or research team.
Michele Chu-Pilli
CONTACT
Renee Miu, DO
CONTACT
University of Arizona
Other
PMR Delivered Via VR - a Cellular Therapy Intervention
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.
Published trials that share one or more normalized conditions with this study.
NCT06999954
Bone Marrow Diseases, Bone Marrow Failure Disorders
Woburn, Massachusetts, United States
View Trial Details