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Objective: To evaluate the effects of different types of music (instrumental Turkish music and Western music without lyrics) played during wound care on pain, anxiety, and patient satisfaction among individuals with venous ulcers.
Methods: In this randomized controlled trial, 97 patients with venous ulcers were assigned to three groups: Western Music (n=32), Turkish Music (n=32), and Control (n=33). Patients in the music groups listened to their assigned music during routine wound dressing, while all patients received individualized, evidence-based care. Pain and anxiety were measured with VAS and STAI before, during, and after dressing, and patient satisfaction was assessed with VAS post-procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Turkish music | Experimental | Music Intervention |
|
| Western music | Experimental | Music Intervention |
|
| control group | No Intervention | control group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Turkish Music Intervention | Other | The music intervention was prepared by a music therapy specialist. Patients in the intervention groups listened only to the music portion of the therapy via a USB player. The music was played continuously and repeatedly in the outpatient clinic for approximately 30-60 minutes (for patients whose dressing lasted at least 30-45 minutes) at a moderate volume of 20-45 dB (sufficient to avoid interfering with speech or communication). To enhance the effectiveness of music therapy, the listening experience was structured with gradual variations in tempo and dynamics. Major tonal sequences were preferred to stimulate neural activity. The selected pieces included instrumental Western Classical music and Turkish music (Nihavend makam), starting at a tempo of 60 bpm (Adagio) and gradually increasing to 100 bpm (Andante). Examples include W.A. Mozart's Flute and Horn Concertos for Western Classical music, and instrumental compositions in the Nihavend makam for Turkish music. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity measured by the Visual Analog Scale (VAS) | Pain intensity will be assessed using a 0-10 cm Visual Analog Scale (VAS), where higher scores indicate more severe pain. | Immediately before wound dressing; Periprocedural period; Immediately after wound dressing |
| State anxiety level measured by the State Anxiety Inventory (STAI-S) score | State anxiety will be assessed using the State Anxiety Inventory (STAI-S), a 20-item validated self-report scale that measures situational (state) anxiety. Scores range from 20 to 80, with higher scores indicating greater anxiety levels. | Before the wound dressing procedure; Immediately after the wound dressing procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| İzmir Katip Çelebi Üniversitesi | Izmir | Turkey (Türkiye) |
De-identified individual participant data (IPD) underlying the primary outcome results will be shared.
Beginning 1 year and ending 2 years after the publication of results
Data will be made available upon reasonable request to the corresponding author. Requests must include a research proposal and will be reviewed for scientific merit and ethical compatibility.
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|
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| Western Music Intervention | Other | The music intervention was prepared by a music therapy specialist. Patients in the intervention groups listened only to the music portion of the therapy via a USB player. The music was played continuously and repeatedly in the outpatient clinic for approximately 30-60 minutes (for patients whose dressing lasted at least 30-45 minutes) at a moderate volume of 20-45 dB (sufficient to avoid interfering with speech or communication).[22] To enhance the effectiveness of music therapy, the listening experience was structured with gradual variations in tempo and dynamics. Major tonal sequences were preferred to stimulate neural activity. The selected pieces included instrumental Western Classical music and Turkish music (Nihavend makam), starting at a tempo of 60 bpm (Adagio) and gradually increasing to 100 bpm (Andante). Examples include W.A. Mozart's Flute and Horn Concertos for Western Classical music, and instrumental compositions in the Nihavend makam for Turkish music. |
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|
| ID | Term |
|---|---|
| D014647 | Varicose Ulcer |
| D010146 | Pain |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D009147 | Music Therapy |
| ID | Term |
|---|---|
| D026421 | Sensory Art Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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