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

NCT06886633 | Enrolling By Invitation

• 1 other identifier: Hasan Kalyoncu University
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

In our planned study, it is envisaged that patients who receive breathing exercises and pressurized cold application will experience a decrease in the level of pain they feel during the debridement process, a decrease in their anxiety levels, and an improvement in their vital signs, and that these study findings will constitute an important data source to reduce the pain and anxiety that occurs during the debridement process.

Conditions

Diabetic Foot Ulcer

Keywords

Debridement; pain; anxiety; Breathing Exercise; Pressurized Cold Application

Outcome Measures

Primary Outcomes (2)

• State Anxiety Scale

  The State Anxiety Inventory (STAI-I) was developed by Spielberger in 1970, adapted to Turkish by Öner N et al. and its validity and reliability study was conducted. The anxiety level is scored as "(1) not at all, (2) a little, (3) a lot and (4) completely" in the STAI-I. Items 3, 4, 6, 7, 9, 12, 13, 14, 17, and 18 in the inventory are positive for 40 (increase total anxiety), and items 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20 are positive (decrease total score). The total score of the reverse statements is subtracted from the total score obtained for direct statements. In scoring, a score between 1 (or -1) and 4 (or -4) is expected for each item according to its positive or negative feature, and 50 is added to the total score to be obtained. The highest score is 80, the lowest score is 20. The higher the total anxiety score, the more anxiety the person has.

  Breathing exercises will be performed 5 minutes before starting the debridement process. The exercise will last approximately 15-20 minutes, and the State Anxiety Scale will be administered before and 5 minutes after debridement process.

• Visual Analog Scale

  The Turkish validity and reliability of this scale, which was developed by Price et al. (1994) to assess the severity of pain, was conducted by Eti Aslan (2004) by assessing the presence of pain in patients in the postoperative period. The scale is graded from 0 to 10, with 0 = no pain, and 10 = unbearable pain.

  The patient will be applied compressive cold 10 minutes before the debridement process. A visual comparison scale will be applied to the patient before, during and 5 minutes after debridement process

Study Arms (3)

Breathing Exercise Group

EXPERIMENTAL

Volunteering to participate in the study, Being 18 years of age or older, Not having a disease that affects breathing such as asthma, COPD, heart failure, Not taking any medication that suppresses anxiety symptoms, Not having a disease that prevents communication such as Alzheimer's or dementia, Not having problems with the ear, nose or throat,

Behavioral: Breathing exercise

Pressurized Cold Application Group

EXPERIMENTAL

Volunteering to participate in the study, Being 18 years of age or older, Not having a disease that affects breathing such as asthma, COPD, heart failure, Not taking any medication that suppresses anxiety symptoms, Not having a disease that prevents communication such as Alzheimer's or dementia, Not having problems with the ear, nose or throat,

Device: Experimental: Pressurized Cold Application Group

control group

NO INTERVENTION

Volunteering to participate in the study, Being 18 years of age or older, Not having a disease that affects breathing such as asthma, COPD, heart failure, Not taking any medication that suppresses anxiety symptoms, Not having a disease that prevents communication such as Alzheimer's or dementia, Not having problems with the ear, nose or throat,

Interventions

Breathing exercise BEHAVIORAL

Patients participating in the breathing exercise group will be trained to apply the breathing exercise at least 1 hour before starting the debridement process. 5 minutes before starting the debridement procedure, the researcher will start breathing exercises in the patient's room. The exercise duration will be approximately 15-20 minutes, and the environment will be quiet, at room temperature and well ventilated during the exercise. The gel part of the pressurized cold therapy bandage will be removed and kept in the refrigerator for at least 2 hours to make it ready for application. The cold gel pack removed from the freezer section of the refrigerator will be placed inside the pressurized cold therapy bandage before application. Pressurized cold will be applied to the patient 10 minutes before starting the debridement procedure.

Breathing Exercise Group

Experimental: Pressurized Cold Application Group DEVICE

The gel part of the pressure cold therapy bandage will be removed and kept in the refrigerator for at least 2 hours to make it ready for application, and the cold gel pack taken from the freezer section of the refrigerator before application will be placed inside the pressure cold therapy bandage. Pressure cold will be applied to the patient 10 minutes before starting the debridement procedure. The patient will be assessed and recorded by a nurse independent of the research on the State Anxiety Scale before and after debridement, and the Visual Comparison Scale before, during and after debridement.

Pressurized Cold Application Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Harran University: lead

Study Sites (1)

Hasan Kalyoncu University

Gaziantep, Gaziantep, 27000, Turkey (Türkiye)

Location

Related Publications (3)

• Chen CT, Tung HH, Chen YC, Wang JL, Tsai SH, Huang YT, Hsu TF. Cold application for pain and anxiety reduction following chest tube removal: A systematic review and meta-analysis. J Clin Nurs. 2023 Feb;32(3-4):574-583. doi: 10.1111/jocn.16315. Epub 2022 Apr 6.

  PMID: 35388557 BACKGROUND

• Hu L, Hua Y, Wang L, Mao Z, Jia X, Lei Z, Chang D, Cheng W. Effect of Short-term Deep Breathing Exercises on Perioperative Anxiety and Pain in Pediatric Orthopedic Patients: A Randomized Controlled Trial. J Perianesth Nurs. 2025 Feb;40(1):69-75. doi: 10.1016/j.jopan.2024.03.009. Epub 2024 Jul 9.

  PMID: 38980240 BACKGROUND

• Dayya D, O'Neill OJ, Huedo-Medina TB, Habib N, Moore J, Iyer K. Debridement of Diabetic Foot Ulcers. Adv Wound Care (New Rochelle). 2022 Dec;11(12):666-686. doi: 10.1089/wound.2021.0016. Epub 2021 Dec 21.

  PMID: 34376065 BACKGROUND

MeSH Terms

Conditions

Diabetic Foot; Pain; Anxiety Disorders

Interventions

Breathing Exercises

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; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: March 20, 2025
• Study Start: March 1, 2025
• Primary Completion: October 15, 2025
• Study Completion: October 30, 2025
• Last Updated: March 20, 2025

Record last verified: 2025-03

Locations

TU (1)