Effect of Music During Wound Debridement

NCT ID: NCT06825325

Last Updated: 2025-02-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-26
• Study Completion Date: 2026-02-26

Brief 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. 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.

Conditions

Debridement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Control Group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention Group- Listening to Sufi Music

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.

Group Type: EXPERIMENTAL

Music Listening

Intervention Type: OTHER

Selection of Sufi music will be played to the patients before the wound debridement.

Interventions

Music Listening

Selection of Sufi music will be played to the patients before the wound debridement.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Afyonkarahisar Health Sciences University

OTHER

Sponsor Role: lead

Responsible Party

Serpil Uyar

Asst. Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Serpil UYAR, Asst. Prof.

Role: PRINCIPAL_INVESTIGATOR

Afyonkarahisar Health Sciences University

Central Contacts

Serpil UYAR, Asst. Prof.

Role: CONTACT

serpilrayu@gmail.com

+905055266016

Other Identifiers

2024/505

Identifier Type: -

Identifier Source: org_study_id