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

Not Applicable

Not yet recruiting

• Conditions: Diabetic Foot Ulcer Associated With Type II Diabetes Mellitus

• Registration Number: NCT07119983
• Lead Sponsor: Cukurova University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-07-28
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-08
• Last Update Submitted: 2025-08-08
• Study First Posted: 2025-08-13
• Last Update Posted: 2025-08-13
• Study Start: 2025-09-01
• Primary Completion: 2026-07-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 84

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain assessment	Before the Procedure, during the Procedure (10th minute), and baseline, after an average of 20-30 minutes	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.
Anxiety Assesment (The Distress Thermometer)	Before the Procedure and baseline, after an average of 20-30 minutes	The Distress Thermometer was first developed by Roth and colleagues for use in identifying non-pathological distress in patients undergoing cancer treatment after answering the necessary questions. The distress level is rated from 0 to 10. The practitioner expresses the distress experienced using the numbers on the thermometer. A score of zero indicates no distress, while a score of 10 indicates the highest level of distress. The green zone encompasses scores from 0 to 3. Individuals experiencing distress within this range are capable of managing their distress. The yellow zone encompasses scores from 4 to 6. A distress score in this range indicates that the individual is unable to manage their distress and requires intervention to return them to the green zone. The red zone encompasses scores from 7 to 10. Individuals experiencing distress within this range require urgent and comprehensive intervention.
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	Heart rate, systolic and diastolic blood pressure, oxygen saturation, and respiratory rate will be recorded before, during, and after debridement. Systolic and diastolic blood pressure will be measured for patients in the study and control groups using the ERKA adult aneroid blood pressure monitor, while oxygen saturation and heart rate will be measured using the Masimo SET® Pulse Oximetry. Both devices will be calibrated before data collection.
Physiological Parameter: heart rate	Before the Procedure, during the Procedure (10th minute), and baseline, after an average of 20-30 minutes	Heart rate will be measured using the Masimo SET® Pulse Oximetry. Devices will be calibrated before data collection.
Physiological Parameters: systolic and diastolic blood pressure	Before the Procedure, during the Procedure (10th minute), and baseline, after an average of 20-30 minutes	Systolic and diastolic blood pressure will be measured for patients in the study and control groups using the ERKA adult aneroid blood pressure monitor
Physiological Parameter: oxygen saturation	Before the Procedure, during the Procedure (10th minute), and baseline, after an average of 20-30 minutes	Oxygen saturation will be measured using the Masimo SET® Pulse Oximetry. Device will be calibrated before data collection.
Physiological Parameter: respiratory rate	Before the Procedure, during the Procedure (10th minute), and baseline, after an average of 20-30 minutes	Respiratory rate will be monitored for one minute, with each inspiration and expiration counted as a breath.

Trial Locations

Locations (1)

Tarsus University; 🇹🇷 Mersin, Tarsus, Turkey