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Completed

NCT Number: NCT06644235

Pain and Comfort in Diabetic Foot Ulcer Care

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).

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Neurologic Manifestations Nutritional and Metabolic Diseases Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Health Sciences University Gazi Yaşargil Training and Research Hospital

Diyarbakır, 21010, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cold Application

Other

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).

Primary outcomes

  1. Pain

    Time frame: 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.

  2. Comfort

    Time frame: 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 outcomes

  1. SINBAD score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mardin Artuklu University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 16, 2024
Registry last updated
Oct 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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