Clinical trial NCT06316115: Effect On Paın And Anxıety Of Stress Ball Use Durıng Sharp Debrıdement
Official title: In Patıents Wıth Dıabetıc Foot Ulcer, Effect On Paın And Anxıety Of Stress Ball Use Durıng Sharp Debrıdement
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetic Foot Ulcer
Keywords: diabetic food ulcer
stress ball
pain
anxciety
Lead sponsor: Harran University
Sponsor class: OTHER
First posted: 2024-03-18
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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 S91.3 and S91.8 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 patient's 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 G\*Power 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 0.70 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 patient's pain and anxiety will be evaluated by a nurse independent of the research before and after the debridement procedure.

Control Group: The patient's 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 \<0.05.

Eligibility criteria: Inclusion Criteria:

* Being 18 years or older,
* Being an inpatient in the endocrinology clinic,
* Volunteer,
* No communication problems (No hearing, understanding and speaking problems),
* Being a patient diagnosed with diabetic foot ulcer,
* The physician decided to apply sharp debridement,
* Having pain according to the Visual Comparison Scale before the sharp debridement procedure,
* Not having a health problem with the hand that would prevent him from using the ball

Exclusion Criteria:

* No pain according to the Visual Comparison Scale,
* Before performing sharp debridement, an intervention decision was taken to reduce pain (local anesthesia).
* administered, nerve blockade, opioid analgesics, etc.) excluded.

Primary outcomes:
measure: Introductory Information Form
timeFrame: at enrollment
Secondary outcomes:
measure: Meggit-Wagner classification of diabetic foot
timeFrame: baseline
Other outcomes:
measure: Visual Comparison Scale
timeFrame: immediately before and after the procedure
measure: State Anxiety scale (STAI)
timeFrame: immediately before and after the procedure
Locations:
city: Şanlıurfa
country: Turkey
facility: Harran Universitesi
Study officials:
affiliation: Harran Universty
name: Fatma ASLAN
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Ozen N, Berse S, Tosun B. Effects of using a stress ball on anxiety and depression in patients undergoing hemodialysis: A prospective, balanced, single-blind, crossover study. Hemodial Int. 2023 Oct;27(4):411-418. doi: 10.1111/hdi.13102. Epub 2023 Jun 15.