Effectiveness of two stress reduction interventions in patients with chronic diabetic foot ulcers (PSY-DFU): protocol for a longitudinal RCT with a nested qualitative study involving family caregivers
Autor(a) principal: | |
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Data de Publicação: | 2022 |
Outros Autores: | , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
Texto Completo: | https://hdl.handle.net/1822/78788 |
Resumo: | Diabetic foot ulcer (DFU) is the leading cause of lower-limb amputations, with a significant impact on patients, families, and society. Since DFU medical treatments represent a major socioeconomic burden, cost-effective interventions are needed. This trial aims to assess the effectiveness of a muscle relaxation intervention compared to a hypnosis intervention versus active and passive control groups on DFU healing, physiological indicators of healing prognosis, and quality of life (QoL) in clinically distressed patients with a chronic DFU. A multicenter, randomized controlled trial with three assessment moments (baseline, two months post-intervention, and four months follow-up) will be conducted. Approximately 170 patients will be randomized and allocated to either treatment or control groups. Primary outcomes will be DFU healing, physiological indicators of healing prognosis, and QoL. Secondary outcomes will include perceived stress, psychological morbidity, and DFU representations. The efficacy of sessions on DFU healing will be qualitatively assessed in 12 patients allocated to the treatment and active control groups, as well as their family caregivers. This study will provide evidence regarding the effectiveness of two psychological interventions for the DFU healing process and the QoL of patients, with direct clinical relevance regarding DFU treatment and recurrence |
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Effectiveness of two stress reduction interventions in patients with chronic diabetic foot ulcers (PSY-DFU): protocol for a longitudinal RCT with a nested qualitative study involving family caregiversDiabetic foot ulcerClinical distressMuscular relaxationHypnosisPhysiological indicators of healing prognosisQuality of lifeRCTProtocol studyCiências Sociais::PsicologiaScience & TechnologyDiabetic foot ulcer (DFU) is the leading cause of lower-limb amputations, with a significant impact on patients, families, and society. Since DFU medical treatments represent a major socioeconomic burden, cost-effective interventions are needed. This trial aims to assess the effectiveness of a muscle relaxation intervention compared to a hypnosis intervention versus active and passive control groups on DFU healing, physiological indicators of healing prognosis, and quality of life (QoL) in clinically distressed patients with a chronic DFU. A multicenter, randomized controlled trial with three assessment moments (baseline, two months post-intervention, and four months follow-up) will be conducted. Approximately 170 patients will be randomized and allocated to either treatment or control groups. Primary outcomes will be DFU healing, physiological indicators of healing prognosis, and QoL. Secondary outcomes will include perceived stress, psychological morbidity, and DFU representations. The efficacy of sessions on DFU healing will be qualitatively assessed in 12 patients allocated to the treatment and active control groups, as well as their family caregivers. This study will provide evidence regarding the effectiveness of two psychological interventions for the DFU healing process and the QoL of patients, with direct clinical relevance regarding DFU treatment and recurrenceThis study was conducted at the Psychology Research Centre (CIPsi/UM) School of Psychology, the University of Minho, supported by the Foundation for Science and Technology (FCT) through the Portuguese State Budget UIDB/01662/2020, UIDB/04539/2020, UIDP/04539/2020 and LA/P/0058/2020, and an FCT grant (PTDC/PSI-GER/28163/2017) assigned to the first and last authors.MDPIUniversidade do MinhoPereira, M. GraçaVilaça, MargaridaCarvalho, Eugénia20222022-01-01T00:00:00Zinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleapplication/pdfhttps://hdl.handle.net/1822/78788engPereira, M.G.; Vilaça, M.; Carvalho, E. Effectiveness of Two Stress Reduction Interventions in Patients with Chronic Diabetic Foot Ulcers (PSY-DFU): Protocol for a Longitudinal RCT with a Nested Qualitative Study Involving Family Caregivers. Int. J. Environ. Res. Public Health 2022, 19, 8556. https://doi.org/10.3390/ijerph191485561660-460110.3390/ijerph1914855635886419https://www.mdpi.com/1660-4601/19/14/8556info:eu-repo/semantics/openAccessreponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãoinstacron:RCAAP2023-07-21T12:00:29Zoai:repositorium.sdum.uminho.pt:1822/78788Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-19T18:50:22.467673Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãofalse |
dc.title.none.fl_str_mv |
Effectiveness of two stress reduction interventions in patients with chronic diabetic foot ulcers (PSY-DFU): protocol for a longitudinal RCT with a nested qualitative study involving family caregivers |
title |
Effectiveness of two stress reduction interventions in patients with chronic diabetic foot ulcers (PSY-DFU): protocol for a longitudinal RCT with a nested qualitative study involving family caregivers |
spellingShingle |
Effectiveness of two stress reduction interventions in patients with chronic diabetic foot ulcers (PSY-DFU): protocol for a longitudinal RCT with a nested qualitative study involving family caregivers Pereira, M. Graça Diabetic foot ulcer Clinical distress Muscular relaxation Hypnosis Physiological indicators of healing prognosis Quality of life RCT Protocol study Ciências Sociais::Psicologia Science & Technology |
title_short |
Effectiveness of two stress reduction interventions in patients with chronic diabetic foot ulcers (PSY-DFU): protocol for a longitudinal RCT with a nested qualitative study involving family caregivers |
title_full |
Effectiveness of two stress reduction interventions in patients with chronic diabetic foot ulcers (PSY-DFU): protocol for a longitudinal RCT with a nested qualitative study involving family caregivers |
title_fullStr |
Effectiveness of two stress reduction interventions in patients with chronic diabetic foot ulcers (PSY-DFU): protocol for a longitudinal RCT with a nested qualitative study involving family caregivers |
title_full_unstemmed |
Effectiveness of two stress reduction interventions in patients with chronic diabetic foot ulcers (PSY-DFU): protocol for a longitudinal RCT with a nested qualitative study involving family caregivers |
title_sort |
Effectiveness of two stress reduction interventions in patients with chronic diabetic foot ulcers (PSY-DFU): protocol for a longitudinal RCT with a nested qualitative study involving family caregivers |
author |
Pereira, M. Graça |
author_facet |
Pereira, M. Graça Vilaça, Margarida Carvalho, Eugénia |
author_role |
author |
author2 |
Vilaça, Margarida Carvalho, Eugénia |
author2_role |
author author |
dc.contributor.none.fl_str_mv |
Universidade do Minho |
dc.contributor.author.fl_str_mv |
Pereira, M. Graça Vilaça, Margarida Carvalho, Eugénia |
dc.subject.por.fl_str_mv |
Diabetic foot ulcer Clinical distress Muscular relaxation Hypnosis Physiological indicators of healing prognosis Quality of life RCT Protocol study Ciências Sociais::Psicologia Science & Technology |
topic |
Diabetic foot ulcer Clinical distress Muscular relaxation Hypnosis Physiological indicators of healing prognosis Quality of life RCT Protocol study Ciências Sociais::Psicologia Science & Technology |
description |
Diabetic foot ulcer (DFU) is the leading cause of lower-limb amputations, with a significant impact on patients, families, and society. Since DFU medical treatments represent a major socioeconomic burden, cost-effective interventions are needed. This trial aims to assess the effectiveness of a muscle relaxation intervention compared to a hypnosis intervention versus active and passive control groups on DFU healing, physiological indicators of healing prognosis, and quality of life (QoL) in clinically distressed patients with a chronic DFU. A multicenter, randomized controlled trial with three assessment moments (baseline, two months post-intervention, and four months follow-up) will be conducted. Approximately 170 patients will be randomized and allocated to either treatment or control groups. Primary outcomes will be DFU healing, physiological indicators of healing prognosis, and QoL. Secondary outcomes will include perceived stress, psychological morbidity, and DFU representations. The efficacy of sessions on DFU healing will be qualitatively assessed in 12 patients allocated to the treatment and active control groups, as well as their family caregivers. This study will provide evidence regarding the effectiveness of two psychological interventions for the DFU healing process and the QoL of patients, with direct clinical relevance regarding DFU treatment and recurrence |
publishDate |
2022 |
dc.date.none.fl_str_mv |
2022 2022-01-01T00:00:00Z |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
https://hdl.handle.net/1822/78788 |
url |
https://hdl.handle.net/1822/78788 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.relation.none.fl_str_mv |
Pereira, M.G.; Vilaça, M.; Carvalho, E. Effectiveness of Two Stress Reduction Interventions in Patients with Chronic Diabetic Foot Ulcers (PSY-DFU): Protocol for a Longitudinal RCT with a Nested Qualitative Study Involving Family Caregivers. Int. J. Environ. Res. Public Health 2022, 19, 8556. https://doi.org/10.3390/ijerph19148556 1660-4601 10.3390/ijerph19148556 35886419 https://www.mdpi.com/1660-4601/19/14/8556 |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
application/pdf |
dc.publisher.none.fl_str_mv |
MDPI |
publisher.none.fl_str_mv |
MDPI |
dc.source.none.fl_str_mv |
reponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação instacron:RCAAP |
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Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação |
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RCAAP |
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RCAAP |
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Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
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Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
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Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação |
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1799132271754608640 |