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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Pain assessment [Срок оценки: Before the Procedure, during the Procedure (10th minute), and baseline, after an average of 20-30 minutes]
• Anxiety Assesment (The Distress Thermometer) [Срок оценки: Before the Procedure and baseline, after an average of 20-30 minutes]
• Physiological Parameters (heart rate, systolic and diastolic blood pressure, oxygen saturation and respiratory rate) [Срок оценки: Before the Procedure, during the Procedure (10th minute), and baseline, after an average of 20-30 minutes]
• Physiological Parameter: heart rate [Срок оценки: Before the Procedure, during the Procedure (10th minute), and baseline, after an average of 20-30 minutes]
• Physiological Parameters: systolic and diastolic blood pressure [Срок оценки: Before the Procedure, during the Procedure (10th minute), and baseline, after an average of 20-30 minutes]
• Physiological Parameter: oxygen saturation [Срок оценки: Before the Procedure, during the Procedure (10th minute), and baseline, after an average of 20-30 minutes]
• Physiological Parameter: respiratory rate [Срок оценки: Before the Procedure, during the Procedure (10th minute), and baseline, after an average of 20-30 minutes]

Критерии участия

Критерии включения

• Patients who agree to participate in the study and sign the Informed Consent
• Form will be included in the study.
• They are over 18 years of age,
• They are literate in Turkish,
• They are undergoing surgical debridement for the first time,
• They are receiving inpatient treatment in the ward, and
• They have pain ≥1 on the Visual Analog Scale (VAS) before the procedure.

Критерии исключения

• Patients who have a diagnosed psychiatric or mental illness,
• Regular painkiller use and chronic pain,
• Visual, hearing, perception, or communication problems,
• Physically impaired (such as an open wound on the hand or lack of muscle strength to squeeze a stress ball),
• Decided to undergo an intervention to reduce pain before debridement (such as local anesthesia, nerve blockade, opioid analgesics, etc.),
• Used non-pharmacological methods to reduce pain before the procedure will not be included in the study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр

• Tarsus University — Mersin

Публикации

• Purcell A, Buckley T, King J, Moyle W, Marshall AP. Topical Analgesic and Local Anesthetic Agents for Pain Associated with Chronic Leg Ulcers: A Systematic Review. Adv Skin Wound Care. 2020 May;33(5):240-251. doi: 10.1097/01.ASW.0000658572.14692.fb. PMID 32304447
• Hajimohammadi K, Parizad N, Bagheri M, Faraji N, Goli R. Maggot therapy, alginate dressing, and surgical sharp debridement: Unique path to save unresponsive diabetic foot ulcer. Int J Surg Case Rep. 2023 Oct;111:108907. doi: 10.1016/j.ijscr.2023.108907. Epub 2023 Oct 4. PMID 37804682
• Shamloul G, Khachemoune A. Reappraisal and updated review of maggot debridement therapy in chronic lower extremity ulcers. Int J Dermatol. 2023 Jul;62(7):962-968. doi: 10.1111/ijd.16619. Epub 2023 Mar 7. PMID 36880424
• McDermott K, Fang M, Boulton AJM, Selvin E, Hicks CW. Etiology, Epidemiology, and Disparities in the Burden of Diabetic Foot Ulcers. Diabetes Care. 2023 Jan 1;46(1):209-221. doi: 10.2337/dci22-0043. PMID 36548709
• Jia H, Wang X, Cheng J. Knowledge, Attitudes, and Practices Associated With Diabetic Foot Prevention Among Rural Adults With Diabetes in North China. Front Public Health. 2022 May 20;10:876105. doi: 10.3389/fpubh.2022.876105. eCollection 2022. PMID 35669753
• Alshammari L, O'Halloran P, McSorley O, Doherty J, Noble H. The effectiveness of foot care educational interventions for people living with diabetes mellitus: An umbrella review. J Tissue Viability. 2023 Aug;32(3):406-416. doi: 10.1016/j.jtv.2023.06.001. Epub 2023 Jun 16. PMID 37369610
• van Netten JJ, Raspovic A, Lavery LA, Monteiro-Soares M, Paton J, Rasmussen A, Sacco ICN, Bus SA. Prevention of foot ulcers in persons with diabetes at risk of ulceration: A systematic review and meta-analysis. Diabetes Metab Res Rev. 2024 Mar;40(3):e3652. doi: 10.1002/dmrr.3652. Epub 2023 May 27. PMID 37243880
• Aslan F, Tosun B, Altinok Ersoy N, Ozen N. The effect of a stress ball on pain and anxiety during sharp debridement in patients with diabetic foot ulcers: A randomized controlled, single-blind study. J Tissue Viability. 2025 May;34(2):100861. doi: 10.1016/j.jtv.2025.100861. Epub 2025 Jan 26. PMID 39892227

Идентификаторы

NCT: NCT07119983 · Stress Ball

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗