Effect On Paın And Anxıety Of Stress Ball Use Durıng Sharp Debrıdement

NCT06316115 | Recruiting

• 1 other identifier: HRRU-KMY-FA-01
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot Ulcer

Keywords

diabetic food ulcer; stress ball; pain; anxciety

Outcome Measures

Primary Outcomes (1)

• Introductory Information Form

  Introductory information formula section by examining studies conducted with products diagnosed with diabetic foot ulcers. Promotional information regime; People's birth year, education level, employment status, income level, place of residence, year of diabetes diagnosis, etc. A total of 13 questions will be asked about.

  at enrollment

Secondary Outcomes (1)

• Meggit-Wagner classification of diabetic foot

  baseline

Other Outcomes (2)

• Visual Comparison Scale

  immediately before and after the procedure

• State Anxiety scale (STAI)

  immediately before and after the procedure

Study Arms (2)

Wound debridement of patients with diabetic foot ulcers

NO INTERVENTION

No Intervention: 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

Patients with diabetic foot ulcers using stress balls during wound debridement

EXPERIMENTAL

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.

Other: In Patıents Wıth Dıabetıc Foot Ulcer, Effect On Paın And Anxıety Of Stress Ball Use Durıng Sharp Debrıdement

Interventions

In Patıents Wıth Dıabetıc Foot Ulcer, Effect On Paın And Anxıety Of Stress Ball Use Durıng Sharp Debrıdement OTHER

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.

Patients with diabetic foot ulcers using stress balls during wound debridement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Harran University: lead

Study Sites (1)

Harran Universitesi

Sanliurfa, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• Bagcivan G, Ozen N, Bayrak D, Cinar FI. Does Being A Cancer Patient or Family Caregiver of A Cancer Patient Affect Stem Cell Donation Awareness? Asia Pac J Oncol Nurs. 2019 Jul 3;7(1):36-43. doi: 10.4103/apjon.apjon_22_19. eCollection 2020 Jan-Mar.

  PMID: 31879682 RESULT

• 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.

  PMID: 37318078 RESULT

• Aslan F, Tosun B, Altinok Ersoy N, Ozen N. The effect of a stress ball on pain and anxiety during sharp debridement in patients with diabetic foot ulcers: A randomized controlled, single-blind study. J Tissue Viability. 2025 May;34(2):100861. doi: 10.1016/j.jtv.2025.100861. Epub 2025 Jan 26.

  PMID: 39892227 DERIVED

MeSH Terms

Conditions

Diabetic Foot; Pain

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Fatma ASLAN

  Harran Universty

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fatma ASLAN

CONTACT

+905427760715; fatmaaslan62@gmail.com

BETÜL TOSUN

CONTACT

+905053652121; tosunbetul@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 18, 2024
• Study Start: December 12, 2023
• Primary Completion: March 10, 2024
• Study Completion: April 10, 2024
• Last Updated: March 18, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)