Clinical trial NCT06825325: Effect of Music During Wound Debridement
Official title: Effect of Music on Pain Relief, Anxiety Reduction, and Feelings of Safety in Patients Undergoing Wound Debridement
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Debridement
Keywords: Debridement
Music
Pain
Anxiety
Sense of Safety
Lead sponsor: Afyonkarahisar Health Sciences University
Sponsor class: OTHER
First posted: 2025-02-13
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Numerical Rating Scale-Pain (NRS-P)
timeFrame: 15 minutes before the procedure and 5 minutes after the procedure
measure: Numerical Rating Scale-Anxiety (NRS-A)
timeFrame: 15 minutes before the procedure and 5 minutes after the procedure
Secondary outcomes:
measure: Safety Feeling Scale
timeFrame: 15 minutes before the procedure and 5 minutes after the procedure
Other outcomes:
Locations:
Study officials:
affiliation: Afyonkarahisar Health Sciences University
name: Serpil UYAR, Asst. Prof.
role: PRINCIPAL_INVESTIGATOR
References: