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

ClinicalTrials.gov IDNCT07119983

PhaseNA

Enrollment84

SponsorCukurova University

Age18 Years

SexALL

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Conditions studied

Diabetic Foot Ulcer Associated With Type II Diabetes Mellitus

About this study

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.

Interventions

Behavioral: 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.

Primary outcomes

Pain assessment (Before the Procedure, during the Procedure (10th minute), and baseline, after an average of 20-30 minutes)
Anxiety Assesment (The Distress Thermometer) (Before the Procedure and baseline, after an average of 20-30 minutes)
Physiological Parameters (heart rate, systolic and diastolic blood pressure, oxygen saturation and respiratory rate) (Before the Procedure, during the Procedure (10th minute), and baseline, after an average of 20-30 minutes)
Physiological Parameter: heart rate (Before the Procedure, during the Procedure (10th minute), and baseline, after an average of 20-30 minutes)
Physiological Parameters: systolic and diastolic blood pressure (Before the Procedure, during the Procedure (10th minute), and baseline, after an average of 20-30 minutes)
Physiological Parameter: oxygen saturation (Before the Procedure, during the Procedure (10th minute), and baseline, after an average of 20-30 minutes)
Physiological Parameter: respiratory rate (Before the Procedure, during the Procedure (10th minute), and baseline, after an average of 20-30 minutes)

Eligibility information

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.

Study locations

Tarsus University, Mersin, Tarsus 33400 Turkey (Türkiye)

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.