The Effect of Different Types of Music on Pain and Anxiety During Wound Care Procedures in Patients With Venous Ulcers

NCT07287254 | Completed

• 1 other identifier: 0553
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Venous Leg Ulcer; Pain; Anxiety

Keywords

Music Therapy; Pain; Anxiety; Venous Leg Ulcer; Wound Dressing; Nursing Intervention

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

Turkish music

EXPERIMENTAL

Music Intervention

Other: Turkish Music Intervention

Western music

EXPERIMENTAL

Music Intervention

Other: Western Music Intervention

control group

NO INTERVENTION

control group

Interventions

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.

Also known as: music therapy

Turkish music

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.

Also known as: Music therapy

Western music

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients attending the outpatient clinic with venous leg ulcers (CEAP classification: C6 - active ulcers)
• Age between 18 and 65 years
• Absence of neuropathy
• Willingness to listen to music and voluntary participation
• Literacy (able to read and write)
• No visual or hearing impairments
• No cognitive deficits; fully oriented to time, place, and person
• Turkish-speaking
• No formal music education

You may not qualify if:

• Diagnosis of diabetes or diabetic foot
• Use of analgesic medications prior to or during routine wound care
• Individuals younger than 18 or older than 65 years
• Patients with psychiatric disorders
• Individuals with intellectual disabilities
• Patients with severe anxiety levels (STAI-S score 60-79 indicating severe anxiety)

Sponsors & Collaborators

• Izmir Katip Celebi University: lead

Study Sites (1)

İzmir Katip Çelebi Üniversitesi

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Varicose Ulcer; Pain; Anxiety Disorders

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof. Dr.

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 17, 2025
• Study Start: May 2, 2023
• Primary Completion: September 20, 2024
• Study Completion: September 20, 2024
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 1 year and ending 2 years after the publication of results
• Access Criteria: 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.

Locations

TU (1)