Clinical trial NCT06644235: Pain and Comfort in Diabetic Foot Ulcer Care
Official title: The Impact of Cold Application on Pain and Comfort During the Process of Diabetic Foot Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: diabetic foot ulser
pain
cold application
comfort
Lead sponsor: Mardin Artuklu University
Sponsor class: OTHER
First posted: 2024-10-16
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Pain
timeFrame: 45 minutes (Time to collect data from each patient)
measure: Comfort
timeFrame: 45 minutes (Time to collect data from each patient)
Secondary outcomes:
measure: SINBAD score
timeFrame: 45 minutes (Time to collect data from each patient)
Other outcomes:
Locations:
city: Diyarbakır
country: Turkey
facility: Health Sciences University Gazi Yaşargil Training and Research Hospital
Study officials:
affiliation: Şırnak Üniversitesi
name: Mensure Turan, PhD
role: PRINCIPAL_INVESTIGATOR
References: