DebridementNCT06825325
Effect of Music During Wound Debridement
A study testing Music Listening in people with Debridement, run by Afyonkarahisar Health Sciences University.
Trial summary
This randomized controlled intervention study aims to investigate the effect of music played before the debridement on patients' anxiety, pain, and sense of safety. The study will be carried out with two groups: The control and the intervention groups with 100 participants for each group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Debridement
- What is being tested?
- Music Listening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 26 Feb 2025to 26 Feb 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or above,
- Visiting the hospital due to diabetic foot,
- Requiring wound debridement,
- Having wound debridement at least once before,
- Without hearing/speech impairment,
- Without a diagnosis of psychiatric disorders,
- Without any professional training in music,
- and volunteered to participate.
Who cannot join
- Patients under 18 years of age,
- Visiting the hospital for other wound causes,
- Having debridement before and after toe amputation,
- Having wound debridement for the first time
- With hearing/speech impairment,
- With a diagnosis of psychiatric disorders,
- With any kind of professional training in music,
- and not willing to participate in the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Music on Pain Relief, Anxiety Reduction, and Feelings of Safety in Patients Undergoing Wound Debridement
This randomized controlled intervention study aims to investigate the effect of music played before the debridement on patients' anxiety, pain, and sense of safety.
The study will be carried out with two groups: The control and the intervention groups with 100 participants for each group. While the control group participants will receive standard care, the intervention group participants will listen to selection of Sufi music before the debridement in addition to standard care.
Read the detailed description
Diabetes Mellitus (DM) is a chronic metabolic disease characterized by hyperglycemia caused by impaired insulin release, insulin action or both of these factors. The International Diabetes Federation Diabetes Atlas reports present global epidemiologic and diabetes-related impact data. According to the global findings of IDF 2021, 537 million adults (aged 20-79) are living with diabetes, representing 1 in 10 people. This number is projected to increase to 643 million by 2030 and 783 million by 2045.
Diabetes, which is becoming more and more common day by day, has many complications. One of the most important and most common chronic complications is "diabetic foot". The World Health Organization (WHO) recommends grouping all foot complications of diabetes, including the ankle, under the name "diabetic foot". The risk of a person with diabetes being admitted to hospital with a foot wound at any point in their life is approximately 35%. Foot ulcers in diabetics are recognized as an important health problem worldwide. Although diabetic foot ulcers are a preventable complication with preventive measures, when they develop, the treatment process is difficult and costly, and it is a major problem that causes limb loss and increased morbidity and mortality.
Debridement, which is a treatment method in diabetic foot wounds, basically contributes to rapid wound healing by turning the chronic wound into an acute wound. Debridement stimulates the tissue and removes the biofilm layer, foreign body and foreign material from the wound. In addition, debridement allows detailed evaluation of the wound and, if necessary, appropriate wound culture. The types of debridement in the literature are surgical, sharp, mechanical, biological, enzymatic and autolytic debridement. Sharp debridement is the removal of all unwanted components from the wound area with a scalpel, scissors or similar cutting instruments. It is an effective method that can be applied at the patient's bedside or in outpatient clinics, does not take time and can be defined as minor surgical intervention.
Debridement should be performed by a clinician specialized in the wound. One of the common problems encountered during sharp debridement in patients with diabetic foot is pain. Pain is included in our nursing diagnoses and can be managed by nurses. Unresolved pain in wound patients significantly affects wound healing, patient compliance with treatment and quality of life. Although sharp debridement is performed at the patient's bedside or in the outpatient clinic and does not require hospitalization, it causes the patient to experience anxiety. In addition, if the pain and anxiety experienced cannot be controlled, it causes a delay in the healing process.
In healthcare, all procedures are designed to restore patients' health, but the essential need for a sense of safety is often overlooked. It is the responsibility of healthcare professionals to foster a sense of safety in patients. When patients feel safety, it leads to numerous positive outcomes, such as improved healthcare delivery, increased patient satisfaction, and enhanced trust in the treatment process.
Traditional and complementary treatments refer to methods that support health needs outside of modern medicine, shaped by various cultures, religions, and beliefs. These treatments are classified into five categories, encompassing over 200 different approaches. One category, body-mind interventions, includes practices such as music, painting, dance, praying, and hypnosis. Music, as part of body-mind interventions, is processed by the temporal lobe and auditory center in the brain. It triggers physiological responses through the limbic system, which can reduce pain intensity by boosting endorphin release.
The literature review revealed a gap in research regarding the impact of music on patients' sense of safety. While numerous studies have explored music's effects on pain management, anxiety, and various diseases, no studies were found specifically examining the role of music in promoting a sense of safety. In Chittoria's study, patients listened to music during dressing and wound debridement as part of an additional intervention, for 10 minutes, three times a day. The results showed a slight reduction in blood pressure and pulse rate when debridement and dressing were performed with music. However, no studies were identified that assessed the combined effects of music on pain, anxiety, and the sense of safety in patients undergoing wound debridement. Understanding these interactions could offer healthcare professionals valuable insights, allowing them to manage pain, anxiety, and security more effectively and consciously.
- Conditions
- Debridement
- Being tested
- Music Listening
- Keywords
- Debridement, Music, Pain, Anxiety, Sense of Safety
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music ListeningOther
Selection of Sufi music will be played to the patients before the wound debridement.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Patients in the control group will not be allowed to listen to music. These patients will receive standard health care in the Diabetic Foot and Wound Care Clinic. |
| Intervention Group- Listening to Sufi Music | Experimental | Patients in this group will listen to Sufi music for 15 minutes before the wound debridement in addition to standard health care in the Diabetic Foot and Wound Care Clinic. Music will be played to the patients with the help of Mp3 player and headphones. Disposable headphone covers will be used for the headphones and the covers will be changed for each patient. Receives: Other: Music Listening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating Scale-Pain (NRS-P)
The Numerical Rating Scale-Pain (NRS-P) is a one-dimensional tool that uses 11 numbers, ranging from 0 to 10, to assess pain intensity. The patient selects the number that most accurately reflects the severity of their pain, with 0 representing "no pain" and 10 indicating "the worst (unbearable) pain". The NRS-P is widely recognized as an effective method for measuring pain intensity, and it is generally considered more valid and reliable than other pain assessment scales.
Measured: 15 minutes before the procedure and 5 minutes after the procedure
Numerical Rating Scale-Anxiety (NRS-A)
The Numerical Rating Scale-Anxiety (NRS-A) has been widely used in research to assess anxiety levels, with its reliability and validity well-established. This scale, which ranges from 0 to 10, measures anxiety from "No Stress" (0) to "Very Bad Stress" (10). A higher score indicates a greater level of anxiety. The scale categorizes raw anxiety scores as follows: 0-no anxiety, 1-3-slightly anxious, 4-6-moderately anxious, 7-9-very or extremely anxious, and 10-the worst imaginable or extremely anxious.
Measured: 15 minutes before the procedure and 5 minutes after the procedure
Secondary outcomes (1)
Safety Feeling Scale
Safety Feeling Scale, developed by Dabaghi et al. in 2023, is designed to assess the sense of security among hospitalized adult patients. It includes four sub-dimensions: effective care (5 items), trust in the healthcare team (3 items), emotional enrichment (2 items), and hygienic facilities (2 items), totaling 12 items. The scale uses a five-point Likert scale for responses:
- Strongly disagree
- Disagree
- Undecided
- Agree
- Strongly agree Raw scale scores range from 12 to 60, with higher scores indicating a stronger sense of safety experienced by the patient in the hospital.
Measured: 15 minutes before the procedure and 5 minutes after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start26 Feb 2025 (estimated)
- Primary completion26 Feb 2026 (estimated)
- Study completion26 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DebridementStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serpil Uyar, Afyonkarahisar Health Sciences University
- Investigators
- Serpil UYAR, Asst. Prof., Principal investigator, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06825325
- Sponsor's protocol ID
- 2024/505
- Status last verified
- Feb 2025
- First submitted
- 9 Feb 2025
- Last updated
- 19 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Music on Pain Relief, Anxiety Reduction, and Feelings of Safety in Patients Undergoing Wound Debridement
- ClinicalTrials.gov ID
- NCT06825325
- Acronym / sponsor ID
- 2024/505
- Conditions
- Debridement
- Keywords
- Debridement, Music, Pain, Anxiety, Sense of Safety
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 26 Feb 2025 (estimated)
- Primary completion
- 26 Feb 2026 (estimated)
- Study completion
- 26 Feb 2026 (estimated)
- First posted
- 13 Feb 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.
This randomized controlled intervention study aims to investigate the effect of music played before the debridement on patients' anxiety, pain, and sense of safety.
The study will be carried out with two groups: The control and the intervention groups with 100 participants for each group. While the control group participants will receive standard care, the intervention group participants will listen to selection of Sufi music before the debridement in addition to standard care.
Detailed description
Diabetes Mellitus (DM) is a chronic metabolic disease characterized by hyperglycemia caused by impaired insulin release, insulin action or both of these factors. The International Diabetes Federation Diabetes Atlas reports present global epidemiologic and diabetes-related impact data. According to the global findings of IDF 2021, 537 million adults (aged 20-79) are living with diabetes, representing 1 in 10 people. This number is projected to increase to 643 million by 2030 and 783 million by 2045.
Diabetes, which is becoming more and more common day by day, has many complications. One of the most important and most common chronic complications is "diabetic foot". The World Health Organization (WHO) recommends grouping all foot complications of diabetes, including the ankle, under the name "diabetic foot". The risk of a person with diabetes being admitted to hospital with a foot wound at any point in their life is approximately 35%. Foot ulcers in diabetics are recognized as an important health problem worldwide. Although diabetic foot ulcers are a preventable complication with preventive measures, when they develop, the treatment process is difficult and costly, and it is a major problem that causes limb loss and increased morbidity and mortality.
Debridement, which is a treatment method in diabetic foot wounds, basically contributes to rapid wound healing by turning the chronic wound into an acute wound. Debridement stimulates the tissue and removes the biofilm layer, foreign body and foreign material from the wound. In addition, debridement allows detailed evaluation of the wound and, if necessary, appropriate wound culture. The types of debridement in the literature are surgical, sharp, mechanical, biological, enzymatic and autolytic debridement. Sharp debridement is the removal of all unwanted components from the wound area with a scalpel, scissors or similar cutting instruments. It is an effective method that can be applied at the patient's bedside or in outpatient clinics, does not take time and can be defined as minor surgical intervention.
Debridement should be performed by a clinician specialized in the wound. One of the common problems encountered during sharp debridement in patients with diabetic foot is pain. Pain is included in our nursing diagnoses and can be managed by nurses. Unresolved pain in wound patients significantly affects wound healing, patient compliance with treatment and quality of life. Although sharp debridement is performed at the patient's bedside or in the outpatient clinic and does not require hospitalization, it causes the patient to experience anxiety. In addition, if the pain and anxiety experienced cannot be controlled, it causes a delay in the healing process.
In healthcare, all procedures are designed to restore patients' health, but the essential need for a sense of safety is often overlooked. It is the responsibility of healthcare professionals to foster a sense of safety in patients. When patients feel safety, it leads to numerous positive outcomes, such as improved healthcare delivery, increased patient satisfaction, and enhanced trust in the treatment process.
Traditional and complementary treatments refer to methods that support health needs outside of modern medicine, shaped by various cultures, religions, and beliefs. These treatments are classified into five categories, encompassing over 200 different approaches. One category, body-mind interventions, includes practices such as music, painting, dance, praying, and hypnosis. Music, as part of body-mind interventions, is processed by the temporal lobe and auditory center in the brain. It triggers physiological responses through the limbic system, which can reduce pain intensity by boosting endorphin release.
The literature review revealed a gap in research regarding the impact of music on patients' sense of safety. While numerous studies have explored music's effects on pain management, anxiety, and various diseases, no studies were found specifically examining the role of music in promoting a sense of safety. In Chittoria's study, patients listened to music during dressing and wound debridement as part of an additional intervention, for 10 minutes, three times a day. The results showed a slight reduction in blood pressure and pulse rate when debridement and dressing were performed with music. However, no studies were identified that assessed the combined effects of music on pain, anxiety, and the sense of safety in patients undergoing wound debridement. Understanding these interactions could offer healthcare professionals valuable insights, allowing them to manage pain, anxiety, and security more effectively and consciously.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Patients in the control group will not be allowed to listen to music. These patients will receive standard health care in the Diabetic Foot and Wound Care Clinic. |
| Intervention Group- Listening to Sufi Music | Experimental | Other: Music ListeningPatients in this group will listen to Sufi music for 15 minutes before the wound debridement in addition to standard health care in the Diabetic Foot and Wound Care Clinic. Music will be played to the patients with the help of Mp3 player and headphones. Disposable headphone covers will be used for the headphones and the covers will be changed for each patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 years of age or above,
- Visiting the hospital due to diabetic foot,
- Requiring wound debridement,
- Having wound debridement at least once before,
- Without hearing/speech impairment,
Key exclusion criteria (8 listed)
- Patients under 18 years of age,
- Visiting the hospital for other wound causes,
- Having debridement before and after toe amputation,
- Having wound debridement for the first time
- With hearing/speech impairment,
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 |
|---|---|---|
| Music ListeningSelection of Sufi music will be played to the patients before the wound debridement. | Other | Intervention Group- Listening to Sufi Music |
Primary outcome
Numerical Rating Scale-Pain (NRS-P)
Time frame: 15 minutes before the procedure and 5 minutes after the procedure
The Numerical Rating Scale-Pain (NRS-P) is a one-dimensional tool that uses 11 numbers, ranging from 0 to 10, to assess pain intensity. The patient selects the number that most accurately reflects the severity of their pain, with 0 representing "no pain" and 10 indicating "the worst (unbearable) pain". The NRS-P is widely recognized as an effective method for measuring pain intensity, and it is generally considered more valid and reliable than other pain assessment scales.
Numerical Rating Scale-Anxiety (NRS-A)
Time frame: 15 minutes before the procedure and 5 minutes after the procedure
The Numerical Rating Scale-Anxiety (NRS-A) has been widely used in research to assess anxiety levels, with its reliability and validity well-established. This scale, which ranges from 0 to 10, measures anxiety from "No Stress" (0) to "Very Bad Stress" (10). A higher score indicates a greater level of anxiety. The scale categorizes raw anxiety scores as follows: 0-no anxiety, 1-3-slightly anxious, 4-6-moderately anxious, 7-9-very or extremely anxious, and 10-the worst imaginable or extremely anxious.
1 secondary outcome
Safety Feeling Scale
Time frame: 15 minutes before the procedure and 5 minutes after the procedure
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 19 Feb 2025.
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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.
Serpil UYAR, Asst. Prof. principal investigator
Afyonkarahisar Health Sciences University
Questions about this trial
What is this clinical trial studying?
A study testing Music Listening in people with Debridement, run by Afyonkarahisar Health Sciences University.
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 8 inclusion and 8 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: opening soon, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Serpil UYAR, Asst. Prof. (+905055266016, serpilrayu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Rating Scale-Pain (NRS-P) (time frame: 15 minutes before the procedure and 5 minutes after the procedure). 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?
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 19 Feb 2025.