Progressive Muscle Relaxation Delivered Via Virtual Reality - an Intervention for Patients Undergoing Cellular Therapy
9 de junio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
40
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Michele Chu-Pilli
- Número de teléfono: 520-626-1183
- Correo electrónico: chum@arizona.edu
Copia de seguridad de contactos de estudio
- Nombre: Renee Miu, DO
- Número de teléfono: 786-505-5779
- Correo electrónico: rmiu@arizona.edu
Ubicaciones de estudio
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Arizona
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Tucson, Arizona, Estados Unidos, 85719
- University of Arizona
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Contacto:
- Renee Miu, DO
- Número de teléfono: 623-570-8939
- Correo electrónico: rmiu@arizona.edu
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Contacto:
- Michele Chu-Pilli
- Correo electrónico: chum@arizona.edu
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Investigador principal:
- Renee Miu, DO
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Intervention arm - single arm feasibility study
Patients will undergo intervention (PMR delivered via VR).
All patients will undergo the intervention.
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Patients will utilize VR headset in the intervention arm.
This headset will be pre-populated with PMR guided meditation videos.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Recruitment, Retention, and Adherence Rates of VR-Guided Progressive Muscle Relaxation (PMR) Intervention
Periodo de tiempo: Enrollment through completion of the 7-day intervention period.
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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.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Symptom Scores Using the Edmonton Symptom Assessment System-Revised (ESAS-r)
Periodo de tiempo: Baseline (Day 1) through Day 7 following enrollment.
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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.
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Baseline (Day 1) through Day 7 following enrollment.
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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)
Periodo de tiempo: Baseline (Day 1) through Day 7 following enrollment.
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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.
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Change in Muscle Relaxation Intensity Using a Visual Analog Scale (VAS)
Periodo de tiempo: Baseline (Day 1) through Day 7 following enrollment.
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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.
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Baseline (Day 1) through Day 7 following enrollment.
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Participant Satisfaction with VR-Guided Progressive Muscle Relaxation Intervention Using a Post-Intervention Acceptability Survey
Periodo de tiempo: Day 7 following enrollment or hospital discharge if earlier.
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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.
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Day 7 following enrollment or hospital discharge if earlier.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de agosto de 2026
Finalización primaria (Estimado)
1 de noviembre de 2026
Finalización del estudio (Estimado)
1 de mayo de 2027
Fechas de registro del estudio
Enviado por primera vez
8 de enero de 2026
Primero enviado que cumplió con los criterios de control de calidad
9 de junio de 2026
Publicado por primera vez (Actual)
16 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
16 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
9 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- STUDY00006185
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Protocol and Study statistical plan will be shared.
Informed consent will also be shared.
Marco de tiempo para compartir IPD
11/01/2025 - 11/01/2026
Criterios de acceso compartido de IPD
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.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- CIF
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .