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NCT07119983
Effect of Stress Ball Applied During Surgical Debridement/Dressing on Pain, Distress, and Physiological Parameters in Patients With Diabetic Foot Ulcers
NA trial testing Stress ball in Diabetic Foot Ulcer Associated With Type II Diabetes Mellitus in 84 participants. Currently enrolling.
1 July 2026
Quick facts
| Lead sponsor | Cukurova University |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | supportive care |
| Enrollment | 84 |
| Start date | 1 November 2025 |
| Primary completion | 1 July 2026 |
| Estimated completion | 1 July 2026 |
| Sites | 1 location across Turkey (Türkiye) |
Drugs / interventions tested
- Stress ball
Conditions studied
- Diabetic Foot Ulcer Associated With Type II Diabetes Mellitus — all drugs for Diabetic Foot Ulcer Associated With Type II Diabetes Mellitus →
Sponsor
Cukurova University
Who can join
18 and older, any sex, with Diabetic Foot Ulcer Associated With Type II Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07119983
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07119983 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Cukurova University
- Last refreshed: 4 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07119983.
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