Pain and Comfort in Diabetic Foot Ulcer Care

NCT ID: NCT06644235

Last Updated: 2024-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2024-07-01

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.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Cold Application Group

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.

Group Type: EXPERIMENTAL

Cold Application

Intervention Type: 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).

Control Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mardin Artuklu University

OTHER

Sponsor Role: lead

Responsible Party

HEDİYE UTLİ

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mensure Turan, PhD

Role: PRINCIPAL_INVESTIGATOR

Şırnak Üniversitesi

Locations

Health Sciences University Gazi Yaşargil Training and Research Hospital

Diyarbakır, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2023/109-4

Identifier Type: -

Identifier Source: org_study_id