At a glance
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Relaxation Intervention in Patients With Diabetic Foot Ulcer: A Pilot Randomized Controlled Trial With a Nested Qualitative Study
In Brief
A clinical study evaluating Muscle Relaxation with Guided Imagery and Neutral Guided Imagery for Diabetes Mellitus and Diabetic Foot Ulcer. Completed, enrolled 54 participants across 2 sites.
Detailed Summary
Diabetic foot ulcers (DFU) are one of the most serious complications of diabetes and can lead to amputations in 85% of cases, resulting in physical, psychological, family, social and economic consequences. Psychological interventions can contribute to the improvement of wound healing and, relaxation, in particular, seems to contribute to faster wound healing. More research is needed to assess the effectiveness of different types of intervention on different types of wounds, in particular on chronic wounds such as DFU. This is a Pilot Randomised Controlled Study of a Psychological Intervention that aims to evaluate the feasibility and acceptability of a muscle relaxation intervention with guided imagery (experimental group - EG) compared to a neutral guided imagery placebo (active control group - ACG) and a group that does not receive any psychological intervention (passive control group - PCG), to inform a future definitive Randomised Controlled Study (RCT) that tests its effectiveness. This study will also examine, qualitatively, the perspectives of patients with DFU on the relaxation intervention, in order to check its acceptability and applicability; as well as the perspectives of health professionals on this adjuvant therapy, its applicability and integration into the care system of multidisciplinary diabetic foot consultations. Participants have a diagnosis of Diabetes Mellitus and Diabetic Foot; one or two chronic ulcers active at the time of assessment; and clinical levels of stress or anxiety or depression. Participants will be randomized by the three conditions - EG, ACG and PCG - and assessed on the day of the first consultation or nursing treatment for chronic DFU (T0), two months later (T1), and six months later (T2; follow-up). Two weeks after T1, an interview will be conducted with patients with DFU that benefited from the relaxation sessions and to the health professionals who provided them the DFU care. The results of the present study will contribute for a better understanding of DFU progression, healing, prevention of re-ulceration and future amputations and, consequently, for the improvement of patients' quality of life.
Study Details
Timeline
Interventions
Relaxation intervention session begins with diaphragmatic breathing, followed by Jacobson's progressive muscle relaxation, which involves the contraction and subsequent relaxation of the 16 muscle groups of the body (forearm, arm, upper forehead, eye, mouth, jaw and throat, neck, shoulder, chest, stomach, thigh, leg and foot). The contraction is performed for 7 seconds while the relaxation lasts for about 40 to 50 seconds. The relaxation of the foot muscle group is only performed on the healthy foot, because dressing and bandages may bandage the foot with the DFU, which together with the typical joint stiffness of the diabetic foot, make it difficult to perform. After muscle relaxation, begins the guided imagery focused on DFU healing. The patient is instructed to think about his/her current state of health and to imagine the DFU as a dark area and the healing relaxation as a light associated to pleasant sensations, which will focus on the foot with DFU to heal it.
This placebo consists on neutral guided imagery focused on themes of the patient's daily life before having DFU. Each session has a theme associated with the patient's life - family, work, friends and leisure. Initially, the patient is asked to think about an event related to the theme of the session of his/her choice, be it positive or negative, which occurred before patient has the current DFU. Then, questions are asked which allow a more detailed reconstruction of the event and the patient is asked to imagine according only to the instructions given. When the whole episode is remembered, the patient is asked to tell what he or she imagined/remembered in each of the questions given.