The Impact of Cold Application on Pain and Comfort During the Process of Diabetic Foot Care
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 68
- Locations
- 2
- Primary Endpoint
- Pain
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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.
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
- SINBAD score(45 minutes (Time to collect data from each patient))
Investigators
HEDİYE UTLİ
Assistant Professor
Mardin Artuklu University