Effectiveness of Relaxation and Hypnosis Interventions in Distressed Patients With Chronic Diabetic Foot Ulcers: A Longitudinal Pilot Randomised Controlled Trial

Diabetic foot ulcer (DFU) healing is a complex and slow process that depends on several factors such as the patient's physical health. However, psychological factors such as distress, which are commonly reported by patients with DFU, may also influence DFU development and recurrence. This pilot randomised control trial (RCT) assesses the effectiveness of progressive muscle relaxation and hypnosis on DFU healing and quality of life (QoL) in distressed patients. Sixty-nine patients who received standard care treatment were randomly assigned to one of four groups: muscle relaxation (TG1), hypnosis (TG2), neutral sessions (active control: ACG), and no intervention (passive control: PCG). Primary outcomes were both DFU healing and QoL. Secondary outcomes were perceived stress, psychological morbidity, and illness (DFU) representations. Patients were assessed at baseline (T0), 2 months after the baseline (T1), and 4 months later (T2). Regarding primary outcomes, comparisons between groups showed significant differences only in DFU healing: TG1, TG2, and ACG reported more improvements than PCG at T1, while TG1 showed more improvements than TG2 and PCG at T2. Results for secondary outcomes revealed less threatening DFU representations in TG1 compared to TG2 and ACG, and more psychological morbidity in TG2 than TG1, both at T1. Within-group analysis in primary outcomes showed DFU healing and physical QoL improvement in all groups, DFU-related QoL improvement in all groups except PCG, and an increase in mental QoL only in TG2 and ACG. Regarding secondary outcomes, results showed a decrease in DFU's representations only in TG1, and a significant decrease in stress and psychological morbidity in TG1, TG2, and ACG. Results suggest that both stress-reduction interventions should be included in the multidisciplinary treatment and rehabilitation plan for distressed patients with DFU(s).