Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Immersive Virtual Reality Intervention for Non-Opioid Pain Management: A Randomized Controlled Trial

15 november 2018 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

140

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.

Studie Locaties

  • Verenigde Staten
    • California
      • Los Angeles, California, Verenigde Staten, 90048
        • Cedars-Sinai Medical Center

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

18 jaar tot 110 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

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: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Apparaat: Virtual Reality
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.
Sham-vergelijker: '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.
Apparaat: Health and Wellness Channel
Relaxing content broadcast passively on the patient in-room television channel.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Pain Intensity Ratings (NRS)
Tijdsspanne: 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.
Approximately every 3-4 hours for the period 48 hours pre and post intervention
Morphine Milligram Equivalents (MME)
Tijdsspanne: assessed at 48 hours before intervention and 48 hours after intervention
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.
assessed at 48 hours before intervention and 48 hours after intervention

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Length of Stay) LOS
Tijdsspanne: 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.
Count of Days in Hospital Stay up to 20

Medewerkers en onderzoekers

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

Sponsor

Cedars-Sinai Medical Center

Onderzoekers

  • Hoofdonderzoeker: Brennan Spiegel, MD, MSHS, Cedars-Sinai Medical Center

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

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 (Werkelijk)

16 november 2016

Primaire voltooiing (Werkelijk)

17 juli 2017

Studie voltooiing (Werkelijk)

17 augustus 2017

Studieregistratiedata

Eerst ingediend

30 augustus 2016

Eerst ingediend dat voldeed aan de QC-criteria

1 september 2016

Eerst geplaatst (Schatting)

2 september 2016

Updates van studierecords

Laatste update geplaatst (Werkelijk)

20 november 2018

Laatste update ingediend die voldeed aan QC-criteria

15 november 2018

Laatst geverifieerd

1 november 2018

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • Pro00045641

Plan Individuele Deelnemersgegevens (IPD)

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

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 .

Klinische onderzoeken op Virtual Reality

Zoek naar vergelijkbare onderzoeken

Sponsors en medewerkers

Medische omstandigheden

Geneesmiddelinterventies

CROs by country

CROs in Bangladesh

Voorwaarden

Zeldzame ziekten

Geneesmiddelinterventies

Voedingssupplementen

Sponsor / medewerkers

Locaties

3
Abonneren