NCT06644235

Pain and Comfort in Diabetic Foot Ulcer Care

The Impact of Cold Application on Pain and Comfort During the Process of Diabetic Foot Care

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Mardin Artuklu University · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to reveal the effect of cold application of 0.9% NaCl solution used during diabetic foot ulcer (DFU) care on the pain and comfort levels of patients. In this direction; - Cold application has no effect on pain and comfort levels in DFU care. - Cold application has an effect on pain and comfort levels in DFU care. Hypotheses were created. In order to reveal the effect of cold application, 0.9% NaCl was compared to the intervention group (+4ͦ C and +8ͦ C); NaCl ( sodium chloride) compared to the control group (+18ͦ C and +24ͦ C).

Detailed description

Diabetic foot ulcer (DFU) prevalence is increasing in parallel with the increasing number of patients with diabetes mellitus (DM). Patients experience pain due to debridement, which is frequently used in DFU care. Therefore, it is seen that nonpharmacological strategies are needed in pain management, unlike pharmacological methods. For this purpose, this single-blind randomized controlled study attempted to provide more information to the literature for supportive care in DFU care. 68 DFU patients were included in the study. After being randomly assigned to the groups, the care solution was applied cold or hot according to the procedure in the DFU care performed in the outpatient clinic. Data were collected before (10 min before), during and after (10 min after) the procedure. Kruskal Wallis, One Way ANOVA, Post Hoc pairwise comparison tests and corrected Bonferroni were used in the analyses.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
OTHER	Cold Application	Before DFU care, the patient was given an appropriate position and the materials (forceps, scalpel, sponge, pad, bandage, etc.) and the temperature of the 0.9% NaCl solution kept in the refrigerator for 24 hours were measured with an infrared thermometer (+4°C to +8°C) and taken to the treatment area. The solution was transferred to a 50 mL syringe in a sterile manner. The solution was instilled into the wound simultaneously with wound care (5-15 min).

Timeline

• Start date: 2023-11-01
• Primary completion: 2024-07-01
• Completion: 2024-07-01
• First posted: 2024-10-16
• Last updated: 2024-10-17

Locations

1 site across 1 country: Turkey (Türkiye)