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

9 juni 2026 bijgewerkt door: Renee Yin Shen Miu, University of Arizona

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

40

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Verenigde Staten
    • Arizona
      • Tucson, Arizona, Verenigde Staten, 85719
        • University of Arizona
        • Contact:
        • Contact:
        • Hoofdonderzoeker:
          • Renee Miu, DO

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Intervention arm - single arm feasibility study
Patients will undergo intervention (PMR delivered via VR). All patients will undergo the intervention.
Combinatie 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Recruitment, Retention, and Adherence Rates of VR-Guided Progressive Muscle Relaxation (PMR) Intervention
Tijdsspanne: 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.
Enrollment through completion of the 7-day intervention period.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Symptom Scores Using the Edmonton Symptom Assessment System-Revised (ESAS-r)
Tijdsspanne: 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.
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)
Tijdsspanne: 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.
Baseline (Day 1) through Day 7 following enrollment.
Change in Muscle Relaxation Intensity Using a Visual Analog Scale (VAS)
Tijdsspanne: 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.
Baseline (Day 1) through Day 7 following enrollment.
Participant Satisfaction with VR-Guided Progressive Muscle Relaxation Intervention Using a Post-Intervention Acceptability Survey
Tijdsspanne: 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.
Day 7 following enrollment or hospital discharge if earlier.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Arizona

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 augustus 2026

Primaire voltooiing (Geschat)

1 november 2026

Studie voltooiing (Geschat)

1 mei 2027

Studieregistratiedata

Eerst ingediend

8 januari 2026

Eerst ingediend dat voldeed aan de QC-criteria

9 juni 2026

Eerst geplaatst (Werkelijk)

16 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

16 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

9 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • STUDY00006185

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

Protocol and Study statistical plan will be shared. Informed consent will also be shared.

IPD-tijdsbestek voor delen

11/01/2025 - 11/01/2026

IPD-toegangscriteria voor delen

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 delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • ICF

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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