Immersive Virtual Reality Intervention for Non-Opioid Pain Management: A Randomized Controlled Trial
15 de novembro de 2018 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Real)
140
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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California
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Los Angeles, California, Estados Unidos, 90048
- Cedars-Sinai Medical Center
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 110 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 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.
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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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Comparador Falso: '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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Pain Intensity Ratings (NRS)
Prazo: Approximately every 3-4 hours for the period 48 hours pre and post intervention
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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)
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Length of Stay) LOS
Prazo: Count of Days in Hospital Stay up to 20
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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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Brennan Spiegel, MD, MSHS, Cedars-Sinai Medical Center
Publicações e links úteis
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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
16 de novembro de 2016
Conclusão Primária (Real)
17 de julho de 2017
Conclusão do estudo (Real)
17 de agosto de 2017
Datas de inscrição no estudo
Enviado pela primeira vez
30 de agosto de 2016
Enviado pela primeira vez que atendeu aos critérios de CQ
1 de setembro de 2016
Primeira postagem (Estimativa)
2 de setembro de 2016
Atualizações de registro de estudo
Última Atualização Postada (Real)
20 de novembro de 2018
Última atualização enviada que atendeu aos critérios de controle de qualidade
15 de novembro de 2018
Última verificação
1 de novembro de 2018
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- Pro00045641
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
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