Laboratory-based Hypnosis Intervention on Pain Responsivity in Adolescents With Sickle Cell Disease
2 de novembro de 2020 atualizado por: Sarah R. Martin, University of California, Los Angeles
The purpose of this study is to test the effects of a laboratory-based hypnosis session compared to an attention control condition on peripheral blood flow, autonomic stress responses, and acute pain responses in adolescents (ages 12-21) with sickle cell disease, and examine how perceived disease-related stigma may affect these responses.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
25
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, 90095
- University of California, Los Angeles
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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
12 anos a 21 anos (Filho, Adulto)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- A diagnosis of sickle cell disease
- Age 12-21 years old
- Fluent in English (the intervention will be delivered in English)
- Participant is cognitively able to provide informed signed consent or assent
- Participant is cognitively able to follow instructions
Exclusion Criteria:
- Under 12 years of age or over 21 years of age
- Not fluent in English
- Pain medication prescription has changed or if they have been hospitalized for a vaso-occlusive episode within 30 days of study participation.
- Diagnosis of a condition (e.g., neurological disorder affecting peripheral sensation, skin abnormality over the stimulus site, obstructive sleep apnea, diabetes, ischemic heart disease) or cognitive impairment that may affect data integrity or the ability to complete study procedures.
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: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Ativo: Attention Control
Participants will listen to a 30-minute historical story.
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A 30-minute historical story read by a research clinician.
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Experimental: Hypnosis
Participants will receive a 30-minute hypnosis session
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A 30-minute Hypnosis session with a trained clinician focused on relaxation and hypnotic suggestions for pain relief and reduced stress responses.
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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 peripheral blood flow before and during the intervention
Prazo: Beginning 15 minutes prior to the intervention (hypnosis or attention control) and continuing during 30 minutes of the intervention
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Peripheral blood flow will be measured using continuous readings of oxygen saturation, pulse rate, and pulse waveform from the thumb and change in blood flow will be assessed by comparing levels of blood flow during the pre-intervention period (15 minutes prior to intervention to a minute before the start of intervention) from blood flow during the intervention period (from the start of the intervention until 30 minutes after the start of the intervention).
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Beginning 15 minutes prior to the intervention (hypnosis or attention control) and continuing during 30 minutes of the intervention
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in pain threshold temperature
Prazo: 12 minutes before the start of the intervention and 15 minutes after the start of the intervention.
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Pain threshold temperature will be determined by when participants report they first feel pain and change in pain threshold temperature will be assessed by comparing pain threshold temperature during the pre-intervention period (12 minutes before the start of the intervention) from pain threshold temperature during the intervention period (15 minutes after the start of the intervention).
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12 minutes before the start of the intervention and 15 minutes after the start of the intervention.
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Change in pain tolerance temperature
Prazo: 9 minutes before the start of the intervention and 18 minutes after the start of the intervention.
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Pain tolerance temperature will be determined by when participants report they can no longer tolerate the pain and change in pain tolerance temperature will be assessed by comparing pain tolerance temperature during the pre-intervention period (9 minutes before the start of the intervention) from pain tolerance temperature during the intervention period (18 minutes after the start of the intervention).
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9 minutes before the start of the intervention and 18 minutes after the start of the intervention.
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Change in heat pulse pain intensity ratings
Prazo: 5 minutes before the start of the intervention and 21 minutes after the start of the intervention.
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Heat pulse pain intensity ratings will be determined by participants' self-report of heat pulse pain intensity (rated on a 0-10 scale, with 0 being no pain and 10 being worst pain), and change in heat pulse pain intensity will be assessed by comparing pain tolerance temperature during the pre-intervention period (5 minutes before the start of the intervention) from heat pulse pain intensity during the intervention period (21 minutes after the start of the intervention).
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5 minutes before the start of the intervention and 21 minutes after the start of the intervention.
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Change in the effect of the intervention on peripheral blood flow at different levels of disease-related stigma
Prazo: 15 minutes prior to the start of the intervention to a minute before the start of the intervention and from the start of the intervention to 30 minutes after the start of the intervention
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Stigma will be assessed via a questionnaire completed prior to the start of the laboratory session and will be compared to the change in effect, which is assessed by comparing levels of blood flow during the pre-intervention period (15 minutes prior to intervention to a minute before the start of intervention) from blood flow during the intervention period (from the start of the intervention until 30 minutes after the start of the intervention).
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15 minutes prior to the start of the intervention to a minute before the start of the intervention and from the start of the intervention to 30 minutes after the start of the intervention
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Change in the effect of the intervention on pain threshold temperature at different levels of disease-related stigma
Prazo: 12 minutes before the start of the intervention and 15 minutes after the start of the intervention
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Stigma will be assessed via a questionnaire completed prior to the start of the laboratory session and will be compared to the change in effect, which is assessed by comparing pain threshold collected 12 minutes before the start of the intervention and 15 minutes after the start of the intervention.
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12 minutes before the start of the intervention and 15 minutes after the start of the intervention
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Change in the effect of the intervention on pain tolerance temperature at different levels of disease-related stigma
Prazo: 9 minutes before the start of the intervention and 18 minutes after the start of the intervention.
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Stigma will be assessed via a questionnaire completed prior to the start of the laboratory session and will be compared to the change in effect, which is assessed by comparing pain tolerance collected 9 minutes before the start of the intervention and 18 minutes after the start of the intervention.
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9 minutes before the start of the intervention and 18 minutes after the start of the intervention.
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Change in the effect of the intervention on heat pulse pain intensity ratings at different levels of disease-related stigma
Prazo: 5 minutes before the start of the intervention and 21 minutes after the start of the intervention.
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Stigma will be assessed via a questionnaire completed prior to the start of the laboratory session and will be compared to the change in effect, which is assessed by comparing pain intensity collected 5 minutes before the start of the intervention and 21 minutes after the start of the intervention.
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5 minutes before the start of the intervention and 21 minutes after the start of the intervention.
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in the effect of the intervention on Skin Conductance Response (SCR)
Prazo: 12-5 minutes prior to the start of the intervention and 15-21 minutes after the start of the intervention
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Skin Conductance Response (SCR) will be measured using continuous readings of electrical properties of the skin on the index finger and change in SCR will be assessed by comparing levels of SCR during the pre-intervention period (12-5 minutes prior to intervention to the start of intervention) from SCR during the intervention period (15-21 minutes after the start of the intervention).
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12-5 minutes prior to the start of the intervention and 15-21 minutes after the start of the intervention
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Change in the effect of the intervention on Heart Rate Variability
Prazo: 12-5 minutes prior to the start of the intervention and 15-21 minutes after the start of the intervention
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Heart Rate Variability (HRV) will be measured using continuous readings of heartbeat intervals and change in HRV will be assessed by comparing HRV during the pre-intervention period (12-5 minutes prior to intervention to the start of intervention) from HRV during the intervention period (15-21 minutes after the start of the intervention).
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12-5 minutes prior to the start of the intervention and 15-21 minutes after the start of the intervention
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Cadeira de estudo: Lonnie K Zeltzer, MD, UCLA Pediatric Pain and Palliative Care Program
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 março de 2018
Conclusão Primária (Real)
30 de junho de 2020
Conclusão do estudo (Real)
1 de novembro de 2020
Datas de inscrição no estudo
Enviado pela primeira vez
1 de dezembro de 2016
Enviado pela primeira vez que atendeu aos critérios de CQ
6 de dezembro de 2016
Primeira postagem (Estimativa)
9 de dezembro de 2016
Atualizações de registro de estudo
Última Atualização Postada (Real)
4 de novembro de 2020
Última atualização enviada que atendeu aos critérios de controle de qualidade
2 de novembro de 2020
Última verificação
1 de novembro de 2020
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- F32sarahmartin2
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