Relaxation intervention to improve diabetic foot ulcer healing: protocol for a pilot study with a nested qualitative study

Relaxation Intervention for Diabetic Foot Ulcer Healing

Study Overview

A pilot study was conducted to assess the feasibility and acceptability of a relaxation intervention for diabetic foot ulcer (DFU) healing. The study compared progressive muscle relaxation with guided imagery (experimental group) to a neutral guided imagery placebo (active control group) and a group that did not receive any psychological intervention (passive control group). The aim was to inform a future definitive trial to test its effectiveness. The study also included a qualitative examination of patients and health professionals’ perspectives regarding the relaxation intervention.

Participant Criteria

Participants had a diagnosis of diabetes and diabetic foot disease, one or two active hard-to-heal ulcers, and clinical levels of stress, anxiety, or depression.

Key Outcomes

The study assessed rates of eligibility, recruitment, refusal, adherence to the study protocol, participation in follow-up, and patient satisfaction with the relaxation intervention as primary outcomes. Secondary outcomes included DFU healing, patients’ quality of life, stress levels, emotional distress, adherence to DFU care, and physiological measures such as arterial pressure and heart rate.

Conclusion

The pilot study provided insights into the benefits of relaxation techniques for patients’ quality of life and DFU healing.

Declaration of Interest

The study was conducted at the Psychology Research Centre, University of Minho, Portugal, and supported by the Foundation for Science and Technology. The authors have no conflicts of interest to declare.

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