Progressive Muscle Relaxation Delivered Via Virtual Reality - an Intervention for Patients Undergoing Cellular Therapy

PMR Delivered Via VR - a Cellular Therapy Intervention

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Heme Malignancy
• Intervention / Treatment: Combination product: Progressive Muscle Relaxation delivered via Virtual Reality

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michele Chu-Pilli; Phone Number: 520-626-1183; Email: chum@arizona.edu
• Study Contact Backup: Name: Renee Miu, DO; Phone Number: 786-505-5779; Email: rmiu@arizona.edu

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85719
      • University of Arizona
      • Contact: Renee Miu, DO; Phone Number: 623-570-8939; Email: rmiu@arizona.edu
      • Contact: Michele Chu-Pilli; Email: chum@arizona.edu
      • Principal Investigator: Renee Miu, DO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Able to provide informed consent
2. Age greater than or equal to 18 years old
3. Either have a planned admission or already be admitted to the in-patient oncology ward (3NW) with cellular therapy needs.
4. Able to understand English
5. Able to sit-up in bed or bedside chair space to utilize VR device at the time of enrollment
6. Able to utilize VR device and computer/laptop to access necessary resources for participation
7. Performance Status as defined by European Cooperative Oncology Group (ECOG) score of 0-2

Exclusion Criteria:

1. Poor performance status of ECOG 3-4
2. Recent use of immersive VR programs for stress relief and/or entertainment (more than 2 days/week within the past 3 months)
3. Participation in another stress-reduction type interventional study within the past 3 months
4. Current or history of seizure, epilepsy, or other known severe neurological or mental health disorders
5. Clinical Sensitivity to flashing light or motion or having balance disorders previously diagnosed
6. Having another medical condition or co-morbidity that may prevent use of VR program or physical materials (e.g., visual or hearing problems, open sores, wounds, skin rash on face, or active infection)
7. Patients with concern for neurotoxicity or acute treatment related neurological issues such as ICANS. ICANS grade 1 maybe eligible to re-enter trial. ICANS grade 2 or greater would be permanently excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention arm - single arm feasibility study; Patients will undergo intervention (PMR delivered via VR). All patients will undergo the intervention.	Combination product: Progressive Muscle Relaxation delivered via Virtual Reality; Patients will utilize VR headset in the intervention arm. This headset will be pre-populated with PMR guided meditation videos.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment, Retention, and Adherence Rates of VR-Guided Progressive Muscle Relaxation (PMR) Intervention	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.	Enrollment through completion of the 7-day intervention period.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Symptom Scores Using the Edmonton Symptom Assessment System-Revised (ESAS-r)	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.	Baseline (Day 1) through Day 7 following enrollment.
Change in Health-Related Quality of Life Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)	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.	Baseline (Day 1) through Day 7 following enrollment.
Change in Muscle Relaxation Intensity Using a Visual Analog Scale (VAS)	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.	Baseline (Day 1) through Day 7 following enrollment.
Participant Satisfaction with VR-Guided Progressive Muscle Relaxation Intervention Using a Post-Intervention Acceptability Survey	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.	Day 7 following enrollment or hospital discharge if earlier.

Collaborators and Investigators

• Sponsor: University of Arizona

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: January 8, 2026
• First Submitted That Met QC Criteria: June 9, 2026
• First Posted (Actual): June 16, 2026

Study Record Updates

• Last Update Posted (Actual): June 16, 2026
• Last Update Submitted That Met QC Criteria: June 9, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00006185

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Protocol and Study statistical plan will be shared. Informed consent will also be shared.
• IPD Sharing Time Frame: 11/01/2025 - 11/01/2026
• IPD Sharing Access Criteria: Clinicians and researchers interested in this study will be able to access IPD. These will be uploaded to the clinical trials.gov website. They will be able to access protocol, informed consent sheet as well as statistical analysis portrayed on protocol.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No