Pain and Comfort in Diabetic Foot Ulcer Care

Not Applicable

Completed

• Conditions: Diabetes Mellitus

• Registration Number: NCT06644235
• Lead Sponsor: Mardin Artuklu University

Brief 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.

Study Timeline

• Study Start: 2023-11-01
• Primary Completion: 2024-07-01
• Study Completion: 2024-07-01
• Status Verified: 2024-10
• Study First Submitted: 2024-10-14
• Study First Submitted QC: 2024-10-14
• Study First Posted: 2024-10-16
• Last Update Submitted: 2024-10-16
• Last Update Posted: 2024-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• Patients over the age of 18 with a diabetic foot wound diagnosed with diabetes mellitus,
• No cognitive impairment,
• No hearing, understanding or speaking problems,
• VAS>3 points,
• Patients who consent to participate in the study

Exclusion Criteria

• Patients who have been decided to have an intervention to reduce pain before the procedure (such as local anesthesia, nerve blockade, opioid analgesics, etc.) -Patients with VAS <3 points,
• Patients with arterial or venous ulcers other than DFU

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain	45 minutes (Time to collect data from each patient)	Pain level was expressed through VAS pain scale; value of "0 = no pain", "1-3 = mild pain", "4-6 = moderate pain", "7-9 = severe pain" and "10 = unbearable pain". While evaluating the pain, the patient marked the facial expression corresponding to his pain.
Comfort	45 minutes (Time to collect data from each patient)	Comfort was measured using the General Comfort Scale Short Form (GCS-SF). The 28-item six-point Likert scale is scored between 28 and 168. It is accepted that the comfort level increases as the score increases.

Secondary Outcome Measures

Name	Time	Method
SINBAD score	45 minutes (Time to collect data from each patient)	The diabetic foot wound assessment (SINBAD) score is a scoring system that evaluates diabetic wounds in 6 categories (1. zone; 2. ischemia, 3. neuropathy, 4. bacterial infection, 5. ulcer area, 6. depth). It is an easy, fast and simple classification that is used by giving 0 or 1 points to each category, with a maximum of 6 points.

Trial Locations

Locations (1)

Health Sciences University Gazi Yaşargil Training and Research Hospital; 🇹🇷 Diyarbakır, Turkey