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

9 juni 2026 uppdaterad av: 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

40

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

  • Förenta staterna
    • Arizona
      • Tucson, Arizona, Förenta staterna, 85719
        • University of Arizona
        • Kontakt:
        • Kontakt:
        • Huvudutredare:
          • Renee Miu, DO

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Intervention arm - single arm feasibility study
Patients will undergo intervention (PMR delivered via VR). All patients will undergo the intervention.
Kombinationsprodukt: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Recruitment, Retention, and Adherence Rates of VR-Guided Progressive Muscle Relaxation (PMR) Intervention
Tidsram: 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.

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Symptom Scores Using the Edmonton Symptom Assessment System-Revised (ESAS-r)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of Arizona

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 augusti 2026

Primärt slutförande (Beräknad)

1 november 2026

Avslutad studie (Beräknad)

1 maj 2027

Studieregistreringsdatum

Först inskickad

8 januari 2026

Först inskickad som uppfyllde QC-kriterierna

9 juni 2026

Första postat (Faktisk)

16 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

16 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

9 juni 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • STUDY00006185

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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

Tidsram för IPD-delning

11/01/2025 - 11/01/2026

Kriterier för IPD Sharing Access

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-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • ICF

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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