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

NCT07119983 | Recruiting

• 1 other identifier: Stress Ball
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetic Foot Ulcer Associated With Type II Diabetes Mellitus

Keywords

Diabetic foot ulcer; sharp debridement; pain; anxiety; stress ball; nursing care

Outcome Measures

Primary Outcomes (7)

• Pain assessment

  Visual Analogue Scale -VAS: The scale was developed by Price and colleagues in 1983 for use in assessing subjectively perceived pain. Eti-Aslan noted in his study that the VAS is more sensitive and better defined in assessing acute pain. It is a 10 cm (100 mm) ruler with the word "painlessness" written on one end and "the most severe pain" written on the other. Participants were asked to indicate the intensity of pain they were currently experiencing, explaining that "0" on the scale means "I feel no pain" and that increasing numbers indicate increased pain intensity. "10" means "I feel the most severe pain." A higher score on the scale indicates increased pain.

  Before the Procedure, during the Procedure (10th minute), and baseline, after an average of 20-30 minutes

• Anxiety Assesment (The Distress Thermometer)

  The Distress Thermometer was first developed by Roth and colleagues for use in identifying non-pathological distress in patients undergoing cancer treatment after answering the necessary questions. The distress level is rated from 0 to 10. The practitioner expresses the distress experienced using the numbers on the thermometer. A score of zero indicates no distress, while a score of 10 indicates the highest level of distress. The green zone encompasses scores from 0 to 3. Individuals experiencing distress within this range are capable of managing their distress. The yellow zone encompasses scores from 4 to 6. A distress score in this range indicates that the individual is unable to manage their distress and requires intervention to return them to the green zone. The red zone encompasses scores from 7 to 10. Individuals experiencing distress within this range require urgent and comprehensive intervention.

  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)

  Heart rate, systolic and diastolic blood pressure, oxygen saturation, and respiratory rate will be recorded before, during, and after debridement. Systolic and diastolic blood pressure will be measured for patients in the study and control groups using the ERKA adult aneroid blood pressure monitor, while oxygen saturation and heart rate will be measured using the Masimo SET® Pulse Oximetry. Both devices will be calibrated before data collection.

  Before the Procedure, during the Procedure (10th minute), and baseline, after an average of 20-30 minutes

• Physiological Parameter: heart rate

  Heart rate will be measured using the Masimo SET® Pulse Oximetry. Devices will be calibrated before data collection.

  Before the Procedure, during the Procedure (10th minute), and baseline, after an average of 20-30 minutes

• Physiological Parameters: systolic and diastolic blood pressure

  Systolic and diastolic blood pressure will be measured for patients in the study and control groups using the ERKA adult aneroid blood pressure monitor

  Before the Procedure, during the Procedure (10th minute), and baseline, after an average of 20-30 minutes

• Physiological Parameter: oxygen saturation

  Oxygen saturation will be measured using the Masimo SET® Pulse Oximetry. Device will be calibrated before data collection.

  Before the Procedure, during the Procedure (10th minute), and baseline, after an average of 20-30 minutes

• Physiological Parameter: respiratory rate

  Respiratory rate will be monitored for one minute, with each inspiration and expiration counted as a breath.

  Before the Procedure, during the Procedure (10th minute), and baseline, after an average of 20-30 minutes

Other Outcomes (1)

• Meggitt-Wagner classification

  in recruitment

Study Arms (2)

Stress ball

EXPERIMENTAL

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

Behavioral: Stress ball

Control Group

NO INTERVENTION

Routine care

Interventions

Stress ball BEHAVIORAL

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Tarsus University

Mersin, Tarsus, 33400, Turkey (Türkiye)

RECRUITING

Related Publications (10)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 33919683 BACKGROUND

• 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.

  PMID: 36578870 BACKGROUND

MeSH Terms

Conditions

Diabetic Foot; Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• DERYA GEZER, Asisstant Professor

  Tarsus University

  STUDY CHAIR

• EZGİ MUTLUAY YAYLA, Asisstant Professor

  Tarsus University

  STUDY DIRECTOR

• DUDU ALPTEKİN, Dr

  CUKUROVA UNİVERSİTY

  STUDY DIRECTOR

Central Study Contacts

Derya GEZER, Asisstant Professor

CONTACT

+905076990081; deryasahhin@hotmail.com

Ezgi Mutluay YAYLA, Asisstant Professor

CONTACT

ezgiyayla@tarsus.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This study is a randomized controlled experimental design aimed at evaluating the effects of stress ball use on pain, anxiety, distress, and physiological parameters during surgical debridement in individuals with diabetic foot ulcers.

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: August 13, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR

Locations

TU (1)