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

Detalhes bibliográficos
Autor(a) principal: Pereira, M. Graça
Data de Publicação: 2022
Outros Autores: Vilaça, Margarida, Carvalho, Eugénia
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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spelling 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
instname_str Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação
instacron_str RCAAP
institution RCAAP
reponame_str Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
collection Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
repository.name.fl_str_mv Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação
repository.mail.fl_str_mv
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