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Recruiting NCT07119983

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

No phase Interventional Diabetic Foot Ulcer Associated With Type II Diabetes Mellitus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Stress ball.
Who it may be relevant to
Registry conditions: Diabetic Foot Ulcer Associated With Type II Diabetes Mellitus. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Behavioral 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.

Primary outcome measures

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

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Supportive care

Study locations

Turkey (Türkiye) · 1 center
  • Tarsus University — Mersin

Publications

  • 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

Identifiers

NCT: NCT07119983 · Stress Ball

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗