Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06334679
Status:
RECRUITING
Last Update Posted:
2024-03-28
First Post:
2024-03-08
Brief Title:
The Effect of Cold Gel Pack Application on Itching in Burn Patients in the Maturation Stage
Sponsor:
Marmara University
Organization:
Marmara University
Study Overview
Official Title:
The Effect of Cold Gel Pack Application on Itching in Burn Patients in the Maturation Stage A Randomized Controlled Study
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Burn is a serious trauma that causes acute damage to the skin and subcutaneous tissues due to the effect of heat electricity radiation physical and chemical substances It has been reported that the incidence of itching is high in burn patients during the maturation stage of wound healing The literature suggests that in managing the symptom of itching skin hydration support along with cold application methods can also be used The integrity of the skin the duration frequency characteristics areas of itching and identifying conditions that increase or decrease itching are important for managing itching This study is planned to be conducted with a randomized controlled design to examine the effect of applying cold gel packs to burn areas of burn patients during the maturation stage on itching This researchers hypothesis is that burn patients who applied cold gel packs to burn areas during the maturation phase had lower itching severity frequency duration intensity than those who did not
Detailed Description:
Patients will be assigned to one of two groups according to the block randomization list given a sequence number according to the date and time of admission In addition to the clinical routine application cold gel pack application will be applied to the patients in Group 1 and the clinical routine application will continue for those in Group 2 To collect data the Patient Diagnosis Form developed by the researcher in line with literature information the Visual Analog Scale for Itching the Bates-Jensen Wound Assessment Tool and the 12-Item Itching Severity Scale whose validity and reliability analysis has been conducted will be used Calculation of the sample size of the study was made with the GPower v317 computer program In the study of Joo et al a total of 26 patient samples were used to represent the universe assuming that the difference in two independent groups was considered statistically significant according to the itching degree averages of burn patients α 005 significance level and 95 power During the research process it was decided to include a total of 60 individuals in the sample with 30 patients in Group-1 Experiment and 30 patients in Group-2 Control taking into account possible losses
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None