NCT07119983Recruiting
Effect of Stress Ball Applied During Surgical Debridement/Dressing on Pain, Distress, and Physiological Parameters in Patients With Diabetic Foot Ulcers
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
Source: ClinicalTrials.gov · Last updated 15 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 84 (estimated)
- First submitted
- 28 Jul 2025
- Start date
- 1 Nov 2025
- Primary completion date
- 1 Jan 2027
- Lead sponsor
- Cukurova University
- Diseases
- Type 2 diabetes
- NCT number
- NCT07119983
What you commit to
- Study type: Interventional
- Planned participants: 84
- From 1 Nov 2025 to the primary completion date, 1 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients who have a diagnosed psychiatric or mental illness,
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tarsus University Coordinator of this site? Confirm its status | Mersin | Turkey (Türkiye) | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.