IA Trial Radar | ||
|---|---|---|
O estudo clínico NCT06635434 para Dor, Câncer Pediátrico está ativo, não recrutando. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui. | ||
Um estudo corresponde aos critérios do filtro
Visualização em cartões
An English/Spanish Mobile Augmented Reality Pain Assessment App for Hispanic/Latino Pediatric Cancer Patients
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT06635434 procura avaliar a viabilidade do dispositivo para Dor, Câncer Pediátrico. Este é um ensaio intervencionista de Fase I inicial. Seu status atual é: ativo, não recrutando. O estudo começou em 5 de fevereiro de 2023 e pretende incluir 16 participantes. Coordenado por ALTality, Inc. e deve ser concluído em 30 de novembro de 2024. Essas informações foram atualizadas no ClinicalTrials.gov em 26 de outubro de 2024.
Resumo
In this SBIR, ALTality, Inc. ("SpellBound") will assess the feasibility of a dual English/Spanish language augmented reality(AR)-enabled tool for assessing inpatient postoperative pain/nausea/vomiting in Hispanic/Latino children and adolescents with cancer in collaboration with bilingual Spanish-speaking anesthesiologists at the MD Anderson Cancer Center. If successful, the AR app will be an immediately implementable and commercially viable method of providing Hispanic/Latino pediatric cancer patients with limited English proficiency an adjunctive tool to overcome infrastructural barriers to receiving translation services in acute care settings that put them at higher risk of under and/or overtreatment of pain by prescription opioids and future prescription opioid dependency and misuse, at no cost to them or their families.
Título oficial
Feasibility of a Dual English/Spanish Mobile Augmented Reality Pain Assessment App to Reduce Postoperative Prescription Opioid Use in Hispanic/Latino Pediatric and Adolescent Cancer Patients
Condições
DorCâncer PediátricoPublicações
Artigos científicos e trabalhos de pesquisa publicados sobre este estudo clínico:- Kamaladevi RK, Elakkumanan LB, Regmi S. Smart Anesthesia-Another Way of Communication During Emergence from Anesthesia Using a Smartphone. Anesth Analg. 2016 Aug;123(2):518. doi: 10.1213/ANE.0000000000001400. No abstract available.
- Gaither JR, Leventhal JM, Ryan SA, Camenga DR. National Trends in Hospitalizations for Opioid Poisonings Among Children and Adolescents, 1997 to 2012. JAMA Pediatr. 2016 Dec 1;170(12):1195-1201. doi: 10.1001/jamapediatrics.2016.2154.
Outros IDs do estudo
Número NCT
Data de início (real)
2023-02-05
Última atualização postada
2024-10-26
Data de conclusão (estimada)
2024-11-30
Inscrição (estimada)
16
Tipo de estudo
Intervencionista
FASE
Fase I inicial
Status
Ativo, não recrutando
Propósito principal
Viabilidade do dispositivo
Alocação do design
N/A
Modelo de intervenção
Grupo único
Cegamento (Mascaramento)
Nenhum (Estudo aberto)
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
ExperimentalAugmented reality-enabled pain assessment deployed on a mobile Age-stratified (age 7-11 and age 12-17 years old) augmented reality app to evaluate for pain and opioid-related adverse events with equivalent English and Spanish text, audio, and narration | AR Pain Assessment Age-stratified (age 7-11 and age 12-17 years old) augmented reality app to evaluate for pain and opioid-related adverse events with equivalent English and Spanish text, audio, and narration |
Desfecho primário
Desfecho secundário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Primary; Percent of enrolled patients who activated/used the app during the PACU stay | Feasibility measured as activation/usage of the app recorded by the device ID for each patient | immediately after the intervention/procedure/surgery |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Total time spent playing on the AR app during the PACU stay | Length of time (minutes) of app usage recorded by the device ID for each patient | immediately after the intervention/procedure/surgery |
Recorded responses about pain assessment from the app | Pain scale score in English or Spanish through the app | immediately after the intervention/procedure/surgery |
Recorded responses about nausea/vomit assessment from the app | Baxter animated retching scale score in English or Spanish through the app | immediately after the intervention/procedure/surgery |
Inpatient opioid consumption | Calculated as morphine equivalent dose of all opioids given | immediately after the intervention/procedure/surgery |
Length of stay | Total time (minutes) spent in the PACU after surgery | immediately after the intervention/procedure/surgery |
Quality of life survey | PedsQL survey administered to child and/or adult caregiver stratified by age | immediately after the intervention/procedure/surgery |
Rate of opioid prescription | The percentage of patients with opioid prescriptions at the time of discharge from the electronic health record | immediately after the intervention/procedure/surgery |
Patient/caregiver satisfaction survey | Asked to the patient/caregiver by the study team - 1) How satisfied were you with regards to your pain management in PACU?, 2) How satisfied were you with regards to your nausea management in PACU?, 3) How satisfied were you with the use of the AR app to help assess your pain and nausea? | immediately after the intervention/procedure/surgery |
Critérios de elegibilidade
Idades elegíveis
Criança
Idade mínima
7 Years
Sexos elegíveis
Todos
- ages 7-17 years old
- child able to provide assent, and a legal guardian able to provide informed consent
- current diagnosis of pediatric cancer
- undergoing surgery for cancer treatment requiring postoperative inpatient hospitalization
- prescribed or expected to be prescribed opioids during inpatient perioperative period
- sufficient mental capacity to comprehend and interact with the game in English or Spanish.
- the inability to play with the SpellBound app from English or Spanish instructions
- daily opioid use within 30 days prior to surgery
- any concerns from the treatment team.
ALTality, Inc.Centro de Câncer MD AndersonSem dados de contato.
1 Locais do estudo em 1 países
Texas
MD Anderson Cancer Center, Houston, Texas, 77054, United States