Venous Leg UlcerMUPAWNCT07287254
The Effect of Different Types of Music on Pain and Anxiety During Wound Care Procedures in Patients With Venous Ulcers
A study testing Turkish Music Intervention and Western Music Intervention in people with Venous Leg Ulcer and Pain, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Venous Leg Ulcer, Pain, Anxiety
- What is being tested?
- Turkish Music Intervention and Western Music Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 May 2023to 20 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- No cognitive deficits; fully oriented to time, place, and person
- Turkish-speaking
- No formal music education
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Different Types of Music on Pain and Anxiety During Wound Care Procedures in Patients With Venous Ulcers: A Randomized Controlled Trial
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
- Being tested
- Turkish Music Intervention, Western Music Intervention
- Keywords
- Music Therapy, Pain, Anxiety, Venous Leg Ulcer, Wound Dressing, Nursing Intervention
- Medical subject headings
- Varicose Ulcer, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Turkish Music InterventionOther
Also called music therapy
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.
Western Music InterventionOther
Also called Music therapy
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.
| Study group | Role | What they receive |
|---|---|---|
| Turkish music | Experimental | Music Intervention Receives: Other: Turkish Music Intervention |
| Western music | Experimental | Music Intervention Receives: Other: Western Music Intervention |
| control group | No intervention | control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Before the wound dressing procedure; Immediately after the wound dressing procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start2 May 2023
- Primary completion20 Sep 2024
- Study completion20 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Leg UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülay OYUR ÇELİK, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07287254
- Sponsor's protocol ID
- 0553
- Acronym
- MUPAW
- Status last verified
- Dec 2025
- First submitted
- 21 Nov 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) underlying the primary outcome results will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Types of Music on Pain and Anxiety During Wound Care Procedures in Patients With Venous Ulcers: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07287254
- Acronym / sponsor ID
- MUPAW / 0553
- Conditions
- Venous Leg Ulcer, Pain, Anxiety
- Keywords
- Music Therapy, Pain, Anxiety, Venous Leg Ulcer, Wound Dressing, Nursing Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 2 May 2023 (actual)
- Primary completion
- 20 Sep 2024 (actual)
- Study completion
- 20 Sep 2024 (actual)
- First posted
- 17 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Turkish music | Experimental | Other: Turkish Music InterventionMusic Intervention |
| Western music | Experimental | Other: Western Music InterventionMusic Intervention |
| control group | No intervention | –control group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Turkish Music InterventionAlso: music therapyThe 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. | Other | Turkish music |
| Western Music InterventionAlso: Music therapyThe 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. | Other | Western music |
Primary outcome
Pain intensity measured by the Visual Analog Scale (VAS)
Time frame: Immediately before wound dressing; Periprocedural period; Immediately after wound dressing
Pain intensity will be assessed using a 0-10 cm Visual Analog Scale (VAS), where higher scores indicate more severe pain.
State anxiety level measured by the State Anxiety Inventory (STAI-S) score
Time frame: Before the wound dressing procedure; Immediately after the wound dressing procedure
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) underlying the primary outcome results will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Turkish Music Intervention and Western Music Intervention in people with Venous Leg Ulcer and Pain, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
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 9 inclusion and 6 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: finished, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity measured by the Visual Analog Scale (VAS) (time frame: Immediately before wound dressing; Periprocedural period; Immediately after wound dressing). 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 17 Dec 2025.