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

N/ARecruitingNCT07119983

Cukurova University84 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Diabetic Foot Ulcer Associated With Type II Diabetes Mellitus

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Pain assessment

Visual Analogue Scale -VAS: The scale was developed by Price and colleagues in 1983 for use in assessing subjectively perceived pain. Eti-Aslan noted in his study that the VAS is more sensitive and better defined in assessing acute pain. It is a 10 cm (100 mm) ruler with the word "painlessness" written on one end and "the most severe pain" written on the other. Participants were asked to indicate the intensity of pain they were currently experiencing, explaining that "0" on the scale means "I feel no pain" and that increasing numbers indicate increased pain intensity. "10" means "I feel the most severe pain." A higher score on the scale indicates increased pain.