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

M. Graça Pereira, Margarida Vilaça and Eugenia Carvalho
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M. Graça Pereira: Psychology Research Centre (CIPsi), School of Psychology, University of Minho, 4710-057 Braga, Portugal
Margarida Vilaça: Psychology Research Centre (CIPsi), School of Psychology, University of Minho, 4710-057 Braga, Portugal
Eugenia Carvalho: Center for Neuroscience and Cell Biology, University of Coimbra, 3004-504 Coimbra, Portugal

IJERPH, 2022, vol. 19, issue 14, 1-14

Abstract: 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.

Keywords: diabetic foot ulcer; clinical distress; muscular relaxation; hypnosis; physiological indicators of healing prognosis; quality of life; RCT; protocol study (search for similar items in EconPapers)
JEL-codes: I I1 I3 Q Q5 (search for similar items in EconPapers)
Date: 2022
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