Progressive Muscle Relaxation Delivered Via Virtual Reality - an Intervention for Patients Undergoing Cellular Therapy
2026年6月9日 更新者：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.
調査の概要
研究の種類
介入
入学 (推定)
40
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Michele Chu-Pilli
- 電話番号：520-626-1183
- メール：chum@arizona.edu
研究連絡先のバックアップ
- 名前：Renee Miu, DO
- 電話番号：786-505-5779
- メール：rmiu@arizona.edu
研究場所
-
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Arizona
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Tucson、Arizona、アメリカ、85719
- University of Arizona
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コンタクト：
- Renee Miu, DO
- 電話番号：623-570-8939
- メール：rmiu@arizona.edu
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コンタクト：
- Michele Chu-Pilli
- メール：chum@arizona.edu
-
主任研究者：
- Renee Miu, DO
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Intervention arm - single arm feasibility study
Patients will undergo intervention (PMR delivered via VR).
All patients will undergo the intervention.
|
Patients will utilize VR headset in the intervention arm.
This headset will be pre-populated with PMR guided meditation videos.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Recruitment, Retention, and Adherence Rates of VR-Guided Progressive Muscle Relaxation (PMR) Intervention
時間枠：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.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Symptom Scores Using the Edmonton Symptom Assessment System-Revised (ESAS-r)
時間枠：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.
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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)
時間枠：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)
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年8月1日
一次修了 (推定)
2026年11月1日
研究の完了 (推定)
2027年5月1日
試験登録日
最初に提出
2026年1月8日
QC基準を満たした最初の提出物
2026年6月9日
最初の投稿 (実際)
2026年6月16日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月16日
QC基準を満たした最後の更新が送信されました
2026年6月9日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- STUDY00006185
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
Protocol and Study statistical plan will be shared.
Informed consent will also be shared.
IPD 共有時間枠
11/01/2025 - 11/01/2026
IPD 共有アクセス基準
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 共有サポート情報タイプ
- STUDY_PROTOCOL
- ICF
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。