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

Last updated: November 26, 2025
Sponsor: Cukurova University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes Mellitus, Type 2

Pain

Ulcers

Treatment

Stress ball

Clinical Study ID

NCT07119983
Stress Ball
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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

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 tosqueeze a stress ball),

  • Decided to undergo an intervention to reduce pain before debridement (such as localanesthesia, nerve blockade, opioid analgesics, etc.),

  • Used non-pharmacological methods to reduce pain before the procedure will not beincluded in the study.

Study Design

Total Participants: 84
Treatment Group(s): 1
Primary Treatment: Stress ball
Phase:
Study Start date:
November 01, 2025
Estimated Completion Date:
July 01, 2026

Connect with a study center

  • Tarsus University

    Mersin, Tarsus 33400
    Turkey

    Site Not Available

  • Tarsus University

    Mersin 304531, Tarsus 33400
    Turkey (Türkiye)

    Active - Recruiting

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