An interventional study of Stress ball in Diabetic Foot Ulcer Associated With Type II Diabetes Mellitus, sponsored by Cukurova University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Cukurova University · Not applicable, Interventional, and Supportive care
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.
1,077 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's planned enrollment of 84 is above the median of 60 across 847 interventional studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →Cukurova University is the lead sponsor of 259 studies on the registry; 50 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The effects of stress balls on pain, distress and physiological parameters during surgical debridement in patients with diabetic foot ulcers will be investigated.
Behavioral: Stress ball
Routine care
The effects of stress balls on pain, distress and physiological parameters during surgical debridement in patients with diabetic foot ulcers will be investigated.
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.
Time frame: Before the Procedure, during the Procedure (10th minute), and baseline, after an average of 20-30 minutes
Anxiety Assesment (The Distress Thermometer)
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.
Time frame: 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)
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.
Time frame: Before the Procedure, during the Procedure (10th minute), and baseline, after an average of 20-30 minutes
Physiological Parameter: heart rate
Heart rate will be measured using the Masimo SET® Pulse Oximetry. Devices will be calibrated before data collection.
Time frame: Before the Procedure, during the Procedure (10th minute), and baseline, after an average of 20-30 minutes
Physiological Parameters: systolic and diastolic blood pressure
Systolic and diastolic blood pressure will be measured for patients in the study and control groups using the ERKA adult aneroid blood pressure monitor
Time frame: Before the Procedure, during the Procedure (10th minute), and baseline, after an average of 20-30 minutes
Physiological Parameter: oxygen saturation
Oxygen saturation will be measured using the Masimo SET® Pulse Oximetry. Device will be calibrated before data collection.
Time frame: Before the Procedure, during the Procedure (10th minute), and baseline, after an average of 20-30 minutes
Physiological Parameter: respiratory rate
Respiratory rate will be monitored for one minute, with each inspiration and expiration counted as a breath.
Time frame: Before the Procedure, during the Procedure (10th minute), and baseline, after an average of 20-30 minutes
Meggitt-Wagner classification
Meggitt-Wagner Classification of Diabetic Foot: The Meggitt-Wagner classification was developed by Meggitt in 1976 and revised by Wagner in 1981. This classification system, which grades the wound into six categories from stage 0 to stage 5 based on the depth of the wound and the presence of osteomyelitis and gangrene, is evaluated based on observational findings, excluding ulcer depth. Findings of ischemia and infection are limited and do not include the presence of neuropathy. However, evaluation of these factors is known to have a positive impact on the healing process of diabetic foot ulcers.
Time frame: in recruitment
Plan to share: Yes — Results regarding the effects of stress ball use on pain, anxiety, and hemodynamic parameters surgical debridement in individuals with diabetic foot ulcers will be shared. However, your personal information will not be shared.
Supporting information: Clinical study report
Started Nov 2025 (actual). Primary completion is estimated for Jan 2027, 14 months after the start.
Of 240 non-industry interventional studies with no phase under Diabetic Foot, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 37. This study's planned 14 months is below that.
Counting every sponsor, half of 343 studies reached it within 22 months; a quarter within 9 and three quarters within 39.
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