Journal
INTERNATIONAL JOURNAL OF ENVIRONMENTAL RESEARCH AND PUBLIC HEALTH
Volume 19, Issue 14, Pages -Publisher
MDPI
DOI: 10.3390/ijerph19148556
Keywords
diabetic foot ulcer; clinical distress; muscular relaxation; hypnosis; physiological indicators of healing prognosis; quality of life; RCT; protocol study
Funding
- Foundation for Science and Technology (FCT) through the Portuguese State Budget [UIDB/01662/2020, UIDB/04539/2020, UIDP/04539/2020, LA/P/0058/2020]
- FCT grant [PTDC/PSI-GER/28163/2017]
- Fundação para a Ciência e a Tecnologia [PTDC/PSI-GER/28163/2017] Funding Source: FCT
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This study aims to assess the effectiveness of muscle relaxation intervention and hypnosis intervention on healing, physiological indicators, and quality of life in patients with chronic DFU. The study will involve a randomized controlled trial with multiple assessments. The findings will have direct clinical relevance for the treatment and recurrence of DFU.
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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