Using a stress ball during surgical debridement for diabetic foot ulcers
Official title: 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
Run by Cukurova University · NCT07119983 · Data updated 2026-11-12
This will test whether squeezing a stress ball during sharp debridement can reduce pain, anxiety, and stress-related heart and breathing changes in adults with diabetic foot ulcers.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 84 (estimated) |
| Sponsor | Cukurova University Academic / other |
| Locations | 1 site (Mersin, Tarsus) |
| Status | Recruiting |
| Started | November 1, 2025 |
| Main results expected | January 1, 2027 |
| Study ends | July 1, 2027 |
| Registry record updated | September 15, 2026 |
| Trial ID | NCT07119983 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with Type II diabetes hospitalized for their first surgical debridement of a diabetic foot ulcer who are literate in Turkish, able to squeeze a stress ball, and have baseline pain of at least 1 on the VAS.
✕Probably not a fit
Patients with hand injuries or weakness, sensory or communication impairments, diagnosed psychiatric illness, regular opioid or chronic pain treatment, or those who receive other pain-reduction interventions before debridement are excluded and unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study enrolls adult inpatients with Type II diabetes undergoing their first surgical sharp debridement for a diabetic foot ulcer. Participants who meet inclusion criteria will be given a stress ball to squeeze during the debridement while pain, self-reported distress, and physiological markers (heart rate, respiratory rate, blood pressure) are recorded. Patients who have used other pain-reduction interventions prior to debridement are excluded to isolate the effect of the stress ball. Data collected at Tarsus University will be analyzed to see if this distraction method reduces pain, anxiety, and immediate stress responses.
Why it matters
Potential benefit: If effective, this inexpensive, non-drug technique could reduce pain and anxiety during debridement, improve patient comfort and cooperation, and simplify nursing care.
How similar studies have gone: Similar distraction techniques and handheld devices have shown modest reductions in procedural pain and anxiety in other clinical settings, but applying a stress ball during sharp debridement for diabetic foot ulcers is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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 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 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.
Where it's running
-
Tarsus University
Mersin, Tarsus, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: Derya GEZER, Asisstant Professor
- Email: deryasahhin@hotmail.com
- Phone: +905076990081
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.