Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07119983

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

Led by Cukurova University · Updated on 2025-12-04

84

Participants Needed

1

Research Sites

34 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients who agree to participate and sign the Informed Consent Form
  • Age 18 years or older
  • Literate in Turkish
  • Undergoing surgical debridement for the first time
  • Receiving inpatient treatment in the hospital ward
  • Have pain score of 1 or higher on the Visual Analog Scale before the procedure
Not Eligible

You will not qualify if you...

  • Diagnosed psychiatric or mental illness
  • Regular use of painkillers or chronic pain
  • Problems with vision, hearing, perception, or communication
  • Physical impairment such as open wound on hand or inability to squeeze a stress ball
  • Planned pain-reducing interventions before debridement (e.g., local anesthesia, nerve block, opioid analgesics)
  • Use of non-pharmacological pain relief methods before the procedure

AI-Screening

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Trial Site Locations

Total: 1 location

1

Tarsus University

Mersin, Tarsus, Turkey (Türkiye), 33400

Actively Recruiting

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Research Team

D

Derya GEZER, Asisstant Professor

CONTACT

E

Ezgi Mutluay YAYLA, Asisstant Professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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