Immersive Virtual Reality Intervention for Non-Opioid Pain Management: A Randomized Controlled Trial
2018年11月15日 更新者：Brennan Spiegel、Cedars-Sinai Medical Center
The study is a randomized controlled trial (RCT) of VR non-opioid management vs. a control "sham" intervention for a broad and representative group of medical and surgical patients with pain.
Hospitalized patients will receive specialized VR interventions, administered via portable VR headsets, to manage breakthrough pain.
Control patients will view content on the in-room Health and Wellness television channel.
Investigators will follow patients throughout the course of their hospitalization and monitor outcomes during and after their stays, including pain levels, medication requests, and quality of life.
調査の概要
詳細な説明
The study population will consist of 120 patients - 60 patients who are exposed to VR, and 60 control patients exposed to an audiovisual "sham" intervention.
Investigators will select up to 120 hospitalized patients at CSMC admitted during the study period of November 2016 to September 2017.
The inpatient wards serve patients ranging in age from 18 to over 100, allowing us to assess the feasibility of using VR across diverse age groups.
Appropriate inpatients will be selected at random by Dr. Rosen or other authorized co-investigators or study staff, who will obtain relevant clinical variables from the EHR.
All patients admitted to the hospital will be considered for the study.
The location and identity of the inpatient will be relayed by their attending physician to a member of the study team, who will deliver a randomly selected intervention (either VR or Health and Wellness Channel) to the patient the same day (at the patient's discretion).
The patient will continue usage as needed for up to 20 days of the hospital stay.
VR Interventions include both relaxing environment and engaging games.
The Health and Wellness Channel includes some of the same types of content, but it is delivered passively through the in-room television system.
Investigators will examine changes in pain level, length of stay, medication requests (amount and timing), Quality of Life, Functioning, and Patient Satisfaction.
研究の種類
介入
入学 (実際)
140
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。
研究場所
-
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California
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Los Angeles、California、アメリカ、90048
- Cedars-Sinai Medical Center
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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
18年～110年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Able to understand the goals of the study and provide informed consent
- Any hospitalized patient under care of CSMC inpatient service (ISP), gastroenterology, or psychiatry, admitted between November 2016 and 30 September 2017, who is not excluded due to criteria listed below.
- At least one pain score ≥ 3 documented in the EHR.
- Received at least three doses of opioid medication for breakthrough pain, documented in the EHR.
- At least 18 years of age
- English speaking
Exclusion Criteria:
- Unable to consent to study due to cognitive difficulty
- Contact Isolation
- Current diagnosis of epilepsy, dementia, or other neurological disease that may prevent use of VR hardware and software
- Sensitivity to flashing light or motion
- Pregnancy, or a medical condition where the patient is prone to frequent nausea or dizziness
- Recent stroke
- Post-transplant patient, or pre-transplant patient with severe illness
- Patient on ventilator, BiPAP, or other breathing assistance equipment
- Injury to the eyes, face, neck, or arms that prevents comfortable use of VR hardware or software, or safe use of the hardware (e.g., open sores, wounds, or skin rash on face)
- Non-English speaking
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：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- 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 |
|---|---|
|
実験的：Virtual Reality
Patients will be allowed to use commercially-available VR equipment in their hospital rooms for up to 20 days, as needed to manage pain as an adjunct to opioid and non-opioid pain medication.
|
A menu of VR experiences, lasting from 3-30 minutes each.
For example, patients may watch a soothing virtual campfire, or fly over a scenic landscape, or play an interactive game.
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偽コンパレータ：'Health and Wellness Channel'
Patients will be allowed to watch relaxing television content in their hospital rooms for up to 20 days, as needed to manage pain as an adjunct to opioid and non-opioid pain medication.
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Relaxing content broadcast passively on the patient in-room television channel.
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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 |
|---|---|---|
|
Pain Intensity Ratings (NRS)
時間枠：Approximately every 3-4 hours for the period 48 hours pre and post intervention
|
The primary outcome was pain intensity collected via ecological momentary assessment in the course of usual care by hospital staff.
At three-to-four hour intervals during waking hours, subjects were asked by their assigned nurse to rate their pain using a standard 11-point numeric rating scale (NRS), where 0 is "no pain" and 10 is "worst imaginable pain."
Data are summarized as pre/post mean and in time-series.
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Approximately every 3-4 hours for the period 48 hours pre and post intervention
|
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Morphine Milligram Equivalents (MME)
時間枠：assessed at 48 hours before intervention and 48 hours after intervention
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Opioid usage was defined as mean total milligrams of morphine equivalent (MME), calculated by first multiplying the quantity of each prescribed medication by the strength of that medication (milligrams of given opioid per unit dispensed), and then multiplying this quantity-strength product by conversion factors derived from published sources to estimate the milligrams of morphine equivalent to the opioids dispensed in the prescription.
The mean pre-intervention MME for subjects in each arm was calculated by adding the morphine equivalents for each prescription dispensed during the 48 hours before intervention, while the post-intervention MME for subjects in each arm was calculated by adding the morphine equivalents for each prescription dispensed during the 48 hours after intervention.
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assessed at 48 hours before intervention and 48 hours after intervention
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Length of Stay) LOS
時間枠：Count of Days in Hospital Stay up to 20
|
defined as the number of days from the date of admission to date of hospital discharge.
Hour of admission was not available in these data, so patients admitted late on Day 0 (i.e., before midnight), and discharged the following calendar day (i.e., between 00:00 and 23:59), were counted as a 1-day hospital stay.
Patients who were admitted and discharged on the same calendar day were considered to have an LOS of 0.
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Count of Days in Hospital Stay up to 20
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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。
捜査官
- 主任研究者：Brennan Spiegel, MD, MSHS、Cedars-Sinai Medical Center
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
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 (実際)
2016年11月16日
一次修了 (実際)
2017年7月17日
研究の完了 (実際)
2017年8月17日
試験登録日
最初に提出
2016年8月30日
QC基準を満たした最初の提出物
2016年9月1日
最初の投稿 (見積もり)
2016年9月2日
学習記録の更新
投稿された最後の更新 (実際)
2018年11月20日
QC基準を満たした最後の更新が送信されました
2018年11月15日
最終確認日
2018年11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
- Pro00045641
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?
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。
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