AzTrials
AzTrials

DebridementNCT06825325

Effect of Music During Wound Debridement

A study testing Music Listening in people with Debridement, run by Afyonkarahisar Health Sciences University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

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.

Serpil UYAR, Asst. Prof. contact

+905055266016

serpilrayu@gmail.com

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 groups in NCT06825325
Study groupRoleWhat they receive
Control GroupNo interventionPatients 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 MusicExperimentalPatients 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.

  1. 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

  2. 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)
  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.

  1. First posted13 Feb 2025
  2. Study start26 Feb 2025 (estimated)
  3. Primary completion26 Feb 2026 (estimated)
  4. Study completion26 Feb 2026 (estimated)

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in