REducing Anxiety in CHildren Undergoing Procedures (REACH-UP!)
Reducing Anxiety in Children Undergoing Procedures
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Description: The study is a quality improvement project and designed as a small pilot randomized control trial. Participants will be randomly assigned to either Group 1 (no intervention) or Group 2 (iPad intervention) via a number generator.
Children randomized to Group 1 receive the standard of care with observation and scoring of the mYPAS-SF occurring at three time points (T1 pre-operative holding area-patient room which is private, T2 induction of anesthesia, T3 awakening from sedation post procedure).
Children randomized to Group 2 will be observed at the same time points (T1, T2, T3) but will additionally interact with an iPad that has a selection of 3 games downloaded (3 games for children ages 4-7 and 3 games for children ages 8-12). The iPad is introduced in between T1 and T2 and then resumed at T3 until discharge from the clinical unit.
Process: Following IRB approval, the steps of the study are:
- . Subjects meeting inclusion criteria (age, first sedated procedure, English speaking) will be identified through daily review of scheduled patient lists by study team members. (CPU Nurse Champions, PI).
- . Potential subjects will be approached in a private area when they arrive for the procedure to make sure they meet the eligibility criteria. Information concerning the study will be presented by the CPU Nurse Champion, PI or Research Assistant.
- . If the family is interested in participating in the study, further explanation and consent and assent (as appropriate) will be obtained by the PI or the Research Assistant from the parent and the child.
- . A demographic questionnaire will be completed following project consenting and enrollment for both groups.
- . The mYPAS-SF (screening tool that requires a 30 second observation at three distinct time points) will be completed for both groups.
- . The iPad will be given to participants randomized to Group 2 T1- Child observed in the private holding room area (observation occurs after getting settled in the private room prior to the procedure)
T2-Child observed prior to the induction of anesthesia (observation occurs just prior to the administration of anesthesia).
T3-Child observed upon return to private holding area and awakening from anesthesia (observation occurs when child awakens from the anesthesia).
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Virginia
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Richmond, Virginia, Estados Unidos, 23298
- Virginia Commonwealth University Health System
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Children admitted for a sedated procedure
- Must be first sedated procedure
- English speaking
- ages 4-12
Exclusion Criteria:
- Non English speaking
- Children younger than 4 and older than 12 years
- Children with developmental disabilities
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Sem intervenção: Control or Group 1
This group receives standard of care for the child receiving a sedated procedure.
There is no intervention for this group.
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Experimental: Intervention group or Group 2
This group receives an iPad with downloaded games to play while waiting for the sedation/procedure and then resume play upon return to the recovery area and awakening.
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iPad with downloaded games will be given to children randomized to group 2 for use during their time in the peri-operative unit
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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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Change in Anxiety Scores With the Addition of the iPad Intervention-Comparing Group 1 to Group 2
Prazo: Immediately following enrollment, immediately before anesthesia, and post-op assessed up to 10 minutes
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The Modified Yale Preoperative Anxiety Scale- Short form (mYPAS-SF) Ratings produce 4 mYPAS scores (1 for each time point) Areas scored: Activity (1,2,3, or 4) Vocalizations (1,2,3,4,5,or 6) Emotional Expressivity (1,2,3, or 4) State of Apparent arousal (1,2,3, or 4) Scoring: Each score is calculated by dividing each item rating by the highest possible rating (i.e., 6 for the "vocalizations" item and 4 for all other items), adding all the produced values, dividing by 5, and multiplying by 100. This calculation produces a score ranging from 23.33 to 100, with higher values indicating higher anxiety. Comparison of scores between Group 1 and Group 2 to see if changes in anxiety scores occurred with the addition of the iPad. All data will be gathered with review at the close of the study which is anticipated to occur in 5/20/2017. |
Immediately following enrollment, immediately before anesthesia, and post-op assessed up to 10 minutes
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Debbie Shockey, DNP, Virginia Commonwealth University
Publicações e links úteis
Publicações Gerais
- Jenkins BN, Fortier MA, Kaplan SH, Mayes LC, Kain ZN. Development of a short version of the modified Yale Preoperative Anxiety Scale. Anesth Analg. 2014 Sep;119(3):643-650. doi: 10.1213/ANE.0000000000000350.
- Kain ZN, Mayes LC, Cicchetti DV, Bagnall AL, Finley JD, Hofstadter MB. The Yale Preoperative Anxiety Scale: how does it compare with a "gold standard"? Anesth Analg. 1997 Oct;85(4):783-8. doi: 10.1097/00000539-199710000-00012.
- Kain ZN, Caldwell-Andrews AA, Mayes LC, Weinberg ME, Wang SM, MacLaren JE, Blount RL. Family-centered preparation for surgery improves perioperative outcomes in children: a randomized controlled trial. Anesthesiology. 2007 Jan;106(1):65-74. doi: 10.1097/00000542-200701000-00013.
- Banchs RJ, Lerman J. Preoperative anxiety management, emergence delirium, and postoperative behavior. Anesthesiol Clin. 2014 Mar;32(1):1-23. doi: 10.1016/j.anclin.2013.10.011.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- HM200008056
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
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