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Search / Trial NCT06886633

The Effect of Breathing Exercise and Pressurized Cold Application on Pain and Anxiety During Sharp Debridement

Launched by HARRAN UNIVERSITY · Mar 19, 2025

Trial Information

Current as of September 17, 2025

Enrolling by invitation

Keywords

Debridement Pain Anxiety Breathing Exercise Pressurized Cold Application

ClinConnect Summary

This study is testing two simple, non-drug ways to reduce pain and anxiety during sharp wound cleaning (debridement) of diabetic foot ulcers. Participants are randomly placed into one of three groups: a breathing exercise group, a pressurized cold therapy group, or a control group with no extra treatment. The researchers will compare pain levels (on a 0–10 scale) and anxiety levels (using a standard anxiety questionnaire) before, during, and after the debridement to see if these methods help.

Who can join? Adults 18 and older with a diabetic foot ulcer who can learn and do the breathing exercises (if taught) and who do not have breathing conditions like asthma or COPD, are not taking medicines that suppress anxiety, do not have dementia, and do not have ear, nose, or throat problems that would interfere with breathing exercises. The trial is taking place at Hasan Kalyoncu University in Gaziantep, Turkey, and aims to enroll about 78 participants. Recruitment is ongoing by invitation, with an expected completion around October 2025. Results aren’t available yet; if effective, these approaches could improve care during wound cleaning and potentially reduce medication use and costs.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Volunteer to participate in the study
  • Those aged 18 and over,
  • Those who were included in the breathing exercise group before the research and who could perform breathing exercises correctly if taught and demonstrated.
  • Do not have a disease that affects breathing such as Asthma, COPD, Heart failure,
  • Not taking any medication that suppresses anxiety symptoms,
  • Do not have a diagnosed disease such as Alzheimer's or Dementia that would hinder communication,
  • Patients included in the breathing exercise group should not have ear, nose or throat problems that may prevent them from performing breathing exercises.
  • Exclusion Criteria:
  • Those who give up being a research participant at any stage of the research,
  • Illiterate
  • Having a diagnosed disease that affects breathing such as Asthma, COPD, Heart failure,
  • Taking any medication that suppresses anxiety symptoms,
  • Cold intolerance or allergy to cold

About Harran University

Harran University is a distinguished academic institution committed to advancing healthcare through innovative research and clinical trials. With a focus on enhancing patient outcomes, the university leverages its multidisciplinary expertise to conduct rigorous scientific investigations. Harran University fosters collaboration among researchers, clinicians, and industry partners to explore novel therapeutic approaches and improve clinical practices. Through its dedication to ethical standards and patient safety, Harran University aims to contribute significantly to the body of medical knowledge and the development of effective treatments.

Locations

Gaziantep, Turkey

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported