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NCT Number: NCT07649512

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • Poor performance status of ECOG 3-4
  • Recent use of immersive VR programs for stress relief and/or entertainment (more than 2 days/week within the past 3 months)
  • Participation in another stress-reduction type interventional study within the past 3 months
  • Current or history of seizure, epilepsy, or other known severe neurological or mental health disorders
  • Clinical Sensitivity to flashing light or motion or having balance disorders previously diagnosed
  • 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)
  • 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.

Treatment and study plan

Progressive Muscle Relaxation delivered via Virtual Reality

Combination Product

Patients will utilize VR headset in the intervention arm. This headset will be pre-populated with PMR guided meditation videos.

Primary outcomes

  1. Recruitment, Retention, and Adherence Rates of VR-Guided Progressive Muscle Relaxation (PMR) Intervention

    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.

Secondary outcomes

  1. Change in Symptom Scores Using the Edmonton Symptom Assessment System-Revised (ESAS-r)

    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.

  2. 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)

    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.

  3. Change in Muscle Relaxation Intensity Using a Visual Analog Scale (VAS)

    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.

  4. Participant Satisfaction with VR-Guided Progressive Muscle Relaxation Intervention Using a Post-Intervention Acceptability Survey

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Michele Chu-Pilli

CONTACT

[email protected]

520-626-1183

Renee Miu, DO

CONTACT

[email protected]

786-505-5779

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Registry information

Official study title

PMR Delivered Via VR - a Cellular Therapy Intervention

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jun 16, 2026
Registry last updated
Jun 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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