RecruitingNot ApplicableNCT07119983

Effect of Stress Ball Applied During Surgical Debridement/Dressing on Pain, Distress, and Physiological Parameters in Patients With Diabetic Foot Ulcers

Effect of Stress Ball Applied During Surgical Debridement/Dressing on Pain, Distress, and Physiological Parameters in Patients With Diabetic Foot Ulcers: A Randomized Controlled Trial


Sponsor

Cukurova University

Enrollment

84 participants

Start Date

Nov 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Diabetes mellitus (DM) is a common metabolic disease characterized by hyperglycemia, resulting from a deficiency or insufficiency of insulin. Diabetic foot ulcers (DFU), a late complication of diabetes, develop as a result of peripheral neuropathy, peripheral arterial disease, and trauma, negatively impacting individuals' quality of life and increasing the rate of hospitalization and amputation. While sharp debridement, one of the most effective methods in the management of diabetic foot ulcers, accelerates healing, it often causes pain and anxiety, which negatively impacts the treatment process. The physiological effects of anxiety include increased respiratory and heart rates, increased blood pressure, and prolonged procedure times. These effects can reduce patient compliance and complicate nursing care. Non-pharmacological interventions offer important alternatives for pain and anxiety management. One such method, the use of a stress ball, is based on a distraction technique and is used to reduce individuals' emotional and physiological stress levels. The literature has demonstrated the positive effects of stress balls during endoscopy, biopsy, and skin procedures. However, there is insufficient evidence regarding the use of stress balls during sharp debridement. Therefore, this study aimed to evaluate the effects of stress balls on pain, distress, and physiological parameters during surgical debridement in patients with diabetic foot ulcers. The results of this study are expected to contribute to nursing care.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether using a stress ball during wound cleaning and dressing changes (surgical debridement) can help reduce pain and anxiety in hospitalized patients. Wound debridement can be a painful and stressful procedure, and the study looks at whether this simple, non-drug method provides relief. **You may be eligible if...** - You are 18 or older and literate in Turkish - You are in the hospital and undergoing surgical wound debridement for the first time - You have a pain score of at least 1 out of 10 before the procedure - You have agreed to participate and signed the consent form **You may NOT be eligible if...** - You have a diagnosed psychiatric or mental illness - You regularly take pain medications - You have had a previous debridement procedure - You are unable to use your hands to hold a stress ball Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALStress ball

The effects of stress balls on pain, distress and physiological parameters during surgical debridement in patients with diabetic foot ulcers will be investigated.


Locations(1)

Tarsus University

Mersin, Tarsus, Turkey (Türkiye)

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NCT07119983