Diabetic Foot UlcerNCT06886633
The Effect of Breathing Exercise and Pressurized Cold Application on Pain and Anxiety During Sharp Debridement
A study testing Breathing exercise and Experimental: Pressurized Cold Application Group in people with Diabetic Foot Ulcer, run by Harran University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- Breathing exercise and Experimental: Pressurized Cold Application Group
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2025to 30 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Hasan Kalyoncu University
Gaziantep, Gaziantep, 27000
About this study
Official title: The Effect of Breathing Exercise and Pressurized Cold Application on Pain and Anxiety During Sharp Debridement in Diabetic Foot Ulcers
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.
Read the detailed description
Approximately half of the diabetic population is at risk for developing foot ulcers. A prevalence study conducted in our country stated that more than 1 million of 7 million patients with diabetes developed diabetic foot ulcers (DAU) and nearly 500,000 patients had diabetic foot infections. Diabetic foot ulcers cause deterioration in the patient's quality of life, significant increase in treatment costs, lower extremity amputations and increased mortality. 50-70% of non-traumatic foot amputations are performed on diabetic foot patients .
When the literature is examined, it is seen that breathing exercises have been used to support the treatment of stress, fatigue and pain since human history. Breathing exercise is a method that ensures body-mind harmony. Conscious deep and slow breathing helps develop conscious control over relaxation and increases awareness. The distracting effect of breathing can be effective in relieving pain through many different mechanisms: Breathing exercises can relieve tension and muscle spasms in the body by reducing stress. Pain is often associated with stress, tension and anxiety. The rhythmic and regular movement of breathing can help calm the mind and become less sensitive to pain. It may increase the release of natural painkillers called endorphins. Deep breathing and relaxation can trigger the release of endorphins in the brain and reduce the perception of pain. There are studies that breathing exercise increases the pain threshold, reduces the level of anxiety by allowing the person to relax, and has healing effects on vital signs.
Cold application is used as an effective alternative treatment to relieve pain and is recommended because it reduces pain as a result of its effect on sensory nociceptors. Compression increases conductivity by ensuring full contact between ice and skin, and reduces blood flow and edema to the tissue by strengthening the effect of cold application in reducing tissue temperature. For this reason, it is stated that using cold and pressure together is a more effective method to reduce the level of pain than applying cold alone. It has been reported that pressurized cold application is an important application in reducing the level of pain in patients undergoing total knee prosthesis. There are studies showing that cold application reduces both the level of pain and the level of anxiety.
It has been reported that cold saline application and stress ball application to reduce pain and anxiety during wound debridement in patients with diabetic foot ulcers reduce the level of pain and anxiety during debridement. According to the literature, there are limited studies on reducing pain and anxiety during debridement in diabetic foot ulcer patients. 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. At the same time, it is thought that using it as an alternative to the use of medication to reduce the level of pain during the procedure will make a significant contribution to reducing treatment costs.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Breathing exercise, Experimental: Pressurized Cold Application Group
- Keywords
- Debridement, pain, anxiety, Breathing Exercise, Pressurized Cold Application
- Medical subject headings
- Diabetic Foot, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing exerciseBehavioural
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.
Experimental: Pressurized Cold Application GroupDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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, Receives: 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, Receives: 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, |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start1 Mar 2025
- Primary completion15 Oct 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harran University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Aslan, Harran University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06886633
- Sponsor's protocol ID
- Hasan Kalyoncu University
- Status last verified
- Mar 2025
- First submitted
- 23 Dec 2024
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35388557Hu 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.
PubMed 38980240Dayya 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.
PubMed 34376065
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Breathing Exercise and Pressurized Cold Application on Pain and Anxiety During Sharp Debridement in Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT06886633
- Acronym / sponsor ID
- Hasan Kalyoncu University
- Conditions
- Diabetic Foot Ulcer
- Keywords
- Debridement, pain, anxiety, Breathing Exercise, Pressurized Cold Application
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Harran UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 15 Oct 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 20 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Approximately half of the diabetic population is at risk for developing foot ulcers. A prevalence study conducted in our country stated that more than 1 million of 7 million patients with diabetes developed diabetic foot ulcers (DAU) and nearly 500,000 patients had diabetic foot infections. Diabetic foot ulcers cause deterioration in the patient's quality of life, significant increase in treatment costs, lower extremity amputations and increased mortality. 50-70% of non-traumatic foot amputations are performed on diabetic foot patients .
When the literature is examined, it is seen that breathing exercises have been used to support the treatment of stress, fatigue and pain since human history. Breathing exercise is a method that ensures body-mind harmony. Conscious deep and slow breathing helps develop conscious control over relaxation and increases awareness. The distracting effect of breathing can be effective in relieving pain through many different mechanisms: Breathing exercises can relieve tension and muscle spasms in the body by reducing stress. Pain is often associated with stress, tension and anxiety. The rhythmic and regular movement of breathing can help calm the mind and become less sensitive to pain. It may increase the release of natural painkillers called endorphins. Deep breathing and relaxation can trigger the release of endorphins in the brain and reduce the perception of pain. There are studies that breathing exercise increases the pain threshold, reduces the level of anxiety by allowing the person to relax, and has healing effects on vital signs.
Cold application is used as an effective alternative treatment to relieve pain and is recommended because it reduces pain as a result of its effect on sensory nociceptors. Compression increases conductivity by ensuring full contact between ice and skin, and reduces blood flow and edema to the tissue by strengthening the effect of cold application in reducing tissue temperature. For this reason, it is stated that using cold and pressure together is a more effective method to reduce the level of pain than applying cold alone. It has been reported that pressurized cold application is an important application in reducing the level of pain in patients undergoing total knee prosthesis. There are studies showing that cold application reduces both the level of pain and the level of anxiety.
It has been reported that cold saline application and stress ball application to reduce pain and anxiety during wound debridement in patients with diabetic foot ulcers reduce the level of pain and anxiety during debridement. According to the literature, there are limited studies on reducing pain and anxiety during debridement in diabetic foot ulcer patients. 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. At the same time, it is thought that using it as an alternative to the use of medication to reduce the level of pain during the procedure will make a significant contribution to reducing treatment costs.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Breathing Exercise Group | Experimental | Behavioral: Breathing exerciseVolunteering 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, |
| Pressurized Cold Application Group | Experimental | Device: Experimental: Pressurized Cold Application GroupVolunteering 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, |
| 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, |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breathing exercisePatients 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. | Behavioural | Breathing Exercise Group |
| Experimental: Pressurized Cold Application GroupThe 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. | Device | Pressurized Cold Application Group |
Primary outcome
State Anxiety Scale
Time frame: 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.
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.
Visual Analog Scale
Time frame: 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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Background: PubMed 35388557Chen 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.
- Background: PubMed 38980240Hu 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.
- Background: PubMed 34376065Dayya 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breathing exercise and Experimental: Pressurized Cold Application Group in people with Diabetic Foot Ulcer, run by Harran University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State Anxiety Scale (time frame: 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06886633, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.