Effect of Stress Ball Applied During Surgical Debridement/Dressing on Pain, Distress, and Physiological Parameters in Patients With Diabetic Foot Ulcers
NCT ID: NCT07119983
Last Updated: 2025-12-04
Study Results
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Basic Information
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RECRUITING
NA
84 participants
INTERVENTIONAL
2025-11-01
2026-07-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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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.
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.
Control Group
Routine care
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Cukurova University
OTHER
Responsible Party
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Derya Gezer
Assistant Professor
Principal Investigators
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DERYA GEZER, Asisstant Professor
Role: STUDY_CHAIR
Tarsus University
EZGİ MUTLUAY YAYLA, Asisstant Professor
Role: STUDY_DIRECTOR
Tarsus University
DUDU ALPTEKİN, Dr
Role: STUDY_DIRECTOR
CUKUROVA UNİVERSİTY
Locations
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Tarsus University
Mersin, Tarsus, Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
Sriubolmas N, Panbangred W, Sriurairatana S, Meevootisom V. Localization and characterization of inclusion bodies in recombinant Escherichia coli cells overproducing penicillin G acylase. Appl Microbiol Biotechnol. 1997 Apr;47(4):373-8. doi: 10.1007/s002530050943.
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.
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.
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.
Najafi B, Mishra R. Harnessing Digital Health Technologies to Remotely Manage Diabetic Foot Syndrome: A Narrative Review. Medicina (Kaunas). 2021 Apr 14;57(4):377. doi: 10.3390/medicina57040377.
Yang L, Rong GC, Wu QN. Diabetic foot ulcer: Challenges and future. World J Diabetes. 2022 Dec 15;13(12):1014-1034. doi: 10.4239/wjd.v13.i12.1014.
Other Identifiers
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Stress Ball
Identifier Type: -
Identifier Source: org_study_id
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