Clinical Hypnosis in Pediatric Crohn's Disease
Palavras-chave
Resumo
datas
Última verificação: | 04/30/2020 |
Enviado pela primeira vez: | 01/02/2019 |
Inscrição estimada enviada: | 01/14/2019 |
Postado pela primeira vez: | 01/17/2019 |
Última atualização enviada: | 05/26/2020 |
Última atualização postada: | 05/27/2020 |
Data real de início do estudo: | 02/13/2019 |
Data Estimada de Conclusão Primária: | 09/29/2019 |
Data Estimada de Conclusão do Estudo: | 04/30/2020 |
Condição ou doença
Intervenção / tratamento
Behavioral: Hypnosis Intervention
Fase
Grupos de Armas
Braço | Intervenção / tratamento |
---|---|
Experimental: Hypnosis Intervention The intervention is clinical hypnosis--a single in-person session followed by instructions to listen to audio recordings at home. The sessions consist of the provider's voice guiding the participant into a relaxed and focused state and providing therapeutic suggestions--for example, to replace discomfort with a more pleasant sensation, to ease anxiety, and to increase energy. | Behavioral: Hypnosis Intervention See information in arm/group description. Four different audio recordings are provided electronically, each approximately 20 minutes in length. Participants are encouraged to listen to one daily. |
No Intervention: Waitlist Control This group will serve as a control comparison and be offered the intervention after control data collection is complete. |
Critério de eleição
Idades qualificadas para estudar | 12 Years Para 12 Years |
Sexos elegíveis para estudo | All |
Aceita Voluntários Saudáveis | sim |
Critério | Inclusion Criteria: - Patients diagnosed with Crohn's disease at least 3 months prior to enrollment - Inactive, mild, or moderate disease activity by Improve Care Now Physician's Global Assessment (ICN PGA) at most recent GI clinic visit - Ages 12-18 years at time of enrollment - English-speaking and with the normal cognitive development required to understand the verbal instructions/suggestions provided in the hypnosis session/audio recordings and to understand and complete the written surveys - Has daily access to an electronic device (ex. smartphone, computer) that can receive text messages or e-mail, on which online surveys can be completed, and on which the participant can access and listen to audio recordings. Exclusion Criteria: - Patients diagnosed with Crohn's disease less than 3 months prior to enrollment - Severe disease activity per ICN PGA at most recent GI clinic visit - Age < 12 years or > 18 years - Non-English speaking or having a cognitive disability that precludes understanding the verbal instructions/suggestions provided in the hypnosis session/audio recordings and the completion of written surveys - Lacks daily access to an electronic device (ex. smartphone, computer) that can receive text messages or e-mail, on which online surveys can be completed, and on which the participant can access and listen to audio recordings. |
Resultado
Medidas de Resultado Primário
1. IMPACT-III [Change from baseline to 8 weeks.]
2. Modified Cantril Ladder [Change from baseline to 8 weeks.]
3. PedsQL 4.0 Generic Core Scale, Parent Proxy [Change from baseline to 8 weeks.]
Medidas de Resultado Secundário
1. PROMIS Pediatric Anxiety, short form [Change from baseline to 8 weeks.]
2. PROMIS Pediatric Depressive Symptoms, short form [Change from baseline to 8 weeks.]
3. PROMIS Pediatric Sleep Disturbance, short form [Change from baseline to 8 weeks.]
4. Pain Beliefs Questionnaire, short form [Change from baseline to 8 weeks.]
5. Abdominal Pain Intensity [Change from baseline to 8 weeks.]
6. Healthcare utilization [Change from baseline to 8 weeks.]
7. School absences [Change from baseline to 8 weeks.]
8. Abdominal Pain Frequency [Change from baseline to 8 weeks.]
Outras medidas de resultado
1. IMPACT-III [Change from baseline to secondary time point at 16 weeks.]
2. PedsQL 4.0 Generic Core Scale, Parent Proxy [Change from baseline to secondary time point at 16 weeks.]
3. Modified Cantril Ladder [change over time monitored weekly for 8 weeks then at secondary time point at 16 weeks]