Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06316115
Status:
RECRUITING
Last Update Posted:
2024-03-18
First Post:
2024-03-01
Brief Title:
Effect On Paın And Anxıety Of Stress Ball Use Durıng Sharp Debrıdement
Sponsor:
Harran University
Organization:
Harran University
Study Overview
Official Title:
In Patıents Wıth Dıabetıc Foot Ulcer Effect On Paın And Anxıety Of Stress Ball Use Durıng Sharp Debrıdement
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:
Diabetic foot ulcer It is a disease used to describe a series of lower extremity complications that may occur together with infection ulceration or gangrene in individuals with diabetes and is coded as S913 and S918 in the International Classification of Diseases ICD Sharp debridement one of the treatments for diabetic foot ulcers is a short-term application performed with a sharp scalpel or scissors at the patients bed or in outpatient clinic conditions It should be performed by a skilled clinician with wound training To our knowledge no study has been found in the literature regarding the use of a stress ball as an intervention to prevent pain and anxiety during sharp debridement In line with this information this study will examine the effect of stress ball use on the pain and anxiety levels of patients with diabetic foot ulcers during wound debridement
Detailed Description:
The annual number of patients hospitalized with diabetic foot ulcer treatment is 543 and the sample calculation of the study was determined using the GPower program Since there was no previous study conducted in the same study group a study examining the effect of stress ball on pain in invasive procedures was taken as reference in the calculation of the sample In this study it was predicted that the difference between pain intensities would be evaluated with a t test and the effect value was predicted to be 070 with a 95 confidence interval and 80 power and it was calculated that 34 participants would be sufficient for the sample Considering possible losses from the study hospitalization death changing treatment center etc a total of 76 patients 38 in each group were aimed to be included in the study
As a data collection tool Introductory Information Form Meggit-Wagner Classification Visual Comparison Scale and State Anxiety Scale STAI will be used
Intervention Group Patients in this group participating in the study will be given a stress ball and asked to use it before the debridement procedure and each patient will be debrided by the same person throughout the procedure The patients pain and anxiety will be evaluated by a nurse independent of the research before and after the debridement procedure
Control Group The patients pain and anxiety will be evaluated by a nurse independent of the research before and during the debridement procedure without any intervention to the patients
Stress ball use Before starting the study the researchers explained to the patients theoretically how to use the stress ball and demonstrated it practically Then the patient was asked to use the ball and it was confirmed whether he was using it correctly Patients will be asked to count to three squeeze the ball once and then relax it inhale each time they squeeze the ball and exhale when they relax it The stress ball used is made of medium hardness and high quality silicone The balls will be provided by the researchers and given to the patients Patients will use the stress ball throughout the debridement procedure and will continue to use it until the procedure is completed Statistical significance level will be accepted as p 005
As a data collection tool Introductory Information Form Meggit-Wagner Classification Visual Comparison Scale and State Anxiety Scale STAI will be used
Intervention Group Patients in this group participating in the study will be given a stress ball and asked to use it before the debridement procedure and each patient will be debrided by the same person throughout the procedure The patients pain and anxiety will be evaluated by a nurse independent of the research before and after the debridement procedure
Control Group The patients pain and anxiety will be evaluated by a nurse independent of the research before and during the debridement procedure without any intervention to the patients
Stress ball use Before starting the study the researchers explained to the patients theoretically how to use the stress ball and demonstrated it practically Then the patient was asked to use the ball and it was confirmed whether he was using it correctly Patients will be asked to count to three squeeze the ball once and then relax it inhale each time they squeeze the ball and exhale when they relax it The stress ball used is made of medium hardness and high quality silicone The balls will be provided by the researchers and given to the patients Patients will use the stress ball throughout the debridement procedure and will continue to use it until the procedure is completed Statistical significance level will be accepted as p 005
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