Pain and Comfort in Diabetic Foot Ulcer Care

NCT06644235 | Completed

• 1 other identifier: 2023/109-4
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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).

Conditions

Diabetes Mellitus

Keywords

diabetic foot ulser; pain; cold application; comfort

Outcome Measures

Primary Outcomes (2)

• Pain

  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.

  45 minutes (Time to collect data from each patient)

• Comfort

  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.

  45 minutes (Time to collect data from each patient)

Secondary Outcomes (1)

• SINBAD score

  45 minutes (Time to collect data from each patient)

Study Arms (2)

Cold Application Group

EXPERIMENTAL

Measurements were taken from the participants in the intervention group in DFU care before (sociodemographic data, the Site, Ischemia, Neuropathy, Bacterial Infection, and Depth (SINBAD) score, score, HbA1c level, pain and comfort levels), during (pain) and after (pain and comfort) cold application.

Other: Cold Application

Control Group

NO INTERVENTION

The solution was used at room temperature (+18°C to +24°C) as used in routine care without any intervention in DFU care.

Interventions

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).

Cold Application Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mardin Artuklu University: lead

Study Sites (1)

Health Sciences University Gazi Yaşargil Training and Research Hospital

Diyarbakır, 21010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus; Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Mensure Turan, PhD

  Şırnak Üniversitesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 14, 2024
• First Posted: October 16, 2024
• Study Start: November 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: October 17, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)