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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Turkey
Tarsus University
RECRUITING
Mersin
Contact Information
Primary
Derya GEZER, Asisstant Professor
deryasahhin@hotmail.com
+905076990081
Backup
Ezgi Mutluay YAYLA, Asisstant Professor
ezgiyayla@tarsus.edu.tr
Time Frame
Start Date: 2025-11-01
Estimated Completion Date: 2026-07-01
Participants
Target number of participants: 84
Treatments
Experimental: Stress ball
The effects of stress balls on pain, distress and physiological parameters during surgical debridement in patients with diabetic foot ulcers will be investigated.
No_intervention: Control Group
Routine care
Sponsors
Leads: Cukurova University

This content was sourced from clinicaltrials.gov