Relaxation Training for People With Chronic Obstructive Pulmonary Disease (COPD)
28 de julho de 2017 atualizado por: Fondazione Don Carlo Gnocchi Onlus
A Quick Relaxation Training for People With Chronic Obstructive Pulmonary Disease (COPD)
People with Chronic Obstructive Pulmonary Disease (COPD) suffer from dyspnoea, which may be exacerbated by psychological outcomes including anxiety and depression.
Previous studies suggest that relaxation techniques may have positive effects on pulmonary rehabilitation.
The main aim of this study is to explore both the respiratory and psychological impact of a quick, one-session, relaxation training for people with Chronic Obstructive Pulmonary Disease (COPD).
Visão geral do estudo
Status
Concluído
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
39
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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Milan, Itália, 20148
- Paolo Banfi
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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 e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Written Informed Consent;
- Chronic Obstructive Pulmonary Disease (COPD) diagnosis confirmed by a specialized physician;
- basal FEV1/FVC <70%, using the standards established by Global Initiative For Chronic Obstructive Lung Disease (GOLD);
- Modified British Medical Research Council Questionnaire (mMRC) ≥ 2;
- COPD Assessment Test (CAT) ≥ 10.
Exclusion Criteria:
- Pregnancy;
- psychiatric disturbances;
- oncological diseases;
- comorbid states that determine an immunosuppressive condition.
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: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Guided Relaxation Technique
Forced Vital Capacity (FVC), Forced Expiratory Volume in the First Second (FEV1), FEV1/FVC, Heart Rate Variability (HRV), airway resistance (kPa/l/s), before and after an 11 minutes, one-session, guided relaxation technique Following 30-40 minutes questionnaire, 5 minutes heart rate (HR) and oxygen saturation (SpO2) recording, 11 minutes relaxation technique (listening via headphone to audio recording.
In the meanwhile, heart rate and saturation are recording) to be completed by second heart rate (HR) and oxygen saturation (SpO2) recording.
Entire procedure 60-80 minutes.
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Outros nomes:
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Comparador Falso: Documentary movie
Forced Vital Capacity (FVC), Forced Expiratory Volume in the First Second (FEV1), FEV1/FVC, Heart Rate Variability (HRV), airway resistance (kPa/l/s), before and after an 11 minutes documentary movie. Following 30-40 minutes questionnaire, 5 minutes heart rate (HR) and oxygen saturation (SpO2) recording, 11 minutes documentary movie (listening via headphone. In the meanwhile, heart rate and saturation are recording) to be completed by second heart rate (HR) and oxygen saturation (SpO2) recording. Entire procedure 60-80 minutes. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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Differences in patients' state of dyspnea, before and after the treatment, as assessed by the Borg Scale (BORG)
Prazo: Baseline and following filling in all the psychological tests and the session of relaxation technique/documentary movie (60-80 minutes elapsed time)
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Baseline and following filling in all the psychological tests and the session of relaxation technique/documentary movie (60-80 minutes elapsed time)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Changes in Heart Rate Variability (HRV), before, during and after the treatment
Prazo: It is recorded for 5 minutes before, during and after the session of relaxation technique/documentary movie (60-80 minutes elapsed time)
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It is recorded for 5 minutes before, during and after the session of relaxation technique/documentary movie (60-80 minutes elapsed time)
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Changes in oxygen saturation (SpO2), before, during and after the treatment
Prazo: It is recorded for 5 minutes before, during and after the session of relaxation technique/documentary movie (60-80 minutes elapsed time)
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It is recorded for 5 minutes before, during and after the session of relaxation technique/documentary movie (60-80 minutes elapsed time)
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Changes in airway resistance (kPa/l/s) before and after the treatment
Prazo: Baseline and following filling in all the psychological tests and the session of relaxation technique/documentary movie (60-80 minutes elapsed time)
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Baseline and following filling in all the psychological tests and the session of relaxation technique/documentary movie (60-80 minutes elapsed time)
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Changes in subjective feelings of anxiety, before and after the treatment, as measured by the State Trait Anxiety Inventory (STAI-Y1)
Prazo: Before the session of relaxation training/documentary movie and after it (60-80 minutes elapsed time)
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Before the session of relaxation training/documentary movie and after it (60-80 minutes elapsed time)
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Changes in the intensity of subjective feelings, before and after the treatment, as assessed by a Visual Analogue Scale (VAS)
Prazo: Before the session of relaxation training/documentary movie and after it (60-80 minutes elapsed time)
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Before the session of relaxation training/documentary movie and after it (60-80 minutes elapsed time)
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Changes in the intensity of positive and negative affects, before and after the treatment, as assessed by the Positive and Negative Affective Schedule (PANAS)
Prazo: Before the session of relaxation training/documentary movie and after it (60-80 minutes elapsed time)
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Before the session of relaxation training/documentary movie and after it (60-80 minutes elapsed time)
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Presence and intensity of the possible subjective experience of engaging just-manageable challenges by tackling a series of goals, continuously processing feedback about progress, and adjusting action based on this feedback, after the treatment
Prazo: After the session of relaxation training/documentary movie (60-80 minutes after the baseline)
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Presence and intensity of the possible state of flow experience, as assessed by a short form of the Flow State Scale, called Short Flow State Scale -2 (FSS-2)
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After the session of relaxation training/documentary movie (60-80 minutes after the baseline)
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Differences in Forced Vital Capacity (FVC), before and after the treatment
Prazo: Baseline and following filling in all the psychological tests and the session of relaxation technique/documentary movie (60-80 minutes elapsed time)
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Baseline and following filling in all the psychological tests and the session of relaxation technique/documentary movie (60-80 minutes elapsed time)
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Differences in Forced Expiratory Volume in The First Second (FEV1), before and after the treatment
Prazo: Baseline and following filling in all the psychological tests and the session of relaxation technique/documentary movie (60-80 minutes elapsed time)
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Baseline and following filling in all the psychological tests and the session of relaxation technique/documentary movie (60-80 minutes elapsed time)
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
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
1 de janeiro de 2016
Conclusão Primária (Real)
1 de março de 2016
Conclusão do estudo (Real)
1 de julho de 2016
Datas de inscrição no estudo
Enviado pela primeira vez
23 de fevereiro de 2016
Enviado pela primeira vez que atendeu aos critérios de CQ
29 de fevereiro de 2016
Primeira postagem (Estimativa)
4 de março de 2016
Atualizações de registro de estudo
Última Atualização Postada (Real)
31 de julho de 2017
Última atualização enviada que atendeu aos critérios de controle de qualidade
28 de julho de 2017
Última verificação
1 de fevereiro de 2016
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- FDG_COPDRELAX_01
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Indeciso
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