Music InterventionNCT07916454
The Effect of Music on Pain During Drain Removal
A study testing Music intervention in people with Music Intervention, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial summary
This research was conducted as a randomized controlled experimental study to examine the effect of music listening during drain removal on pain in patients undergoing total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Music Intervention
- What is being tested?
- Music intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Mar 2024to 15 Oct 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 and over,
- Who do not have any psychiatric disorders,
- Who can speak and read Turkish,
- Who do not have visual or hearing impairments and
- Who volunteered to participate in the study were included.
Who cannot join
- The patient's voluntary withdrawal from the study,
- Removing the ear headphones during the procedure,
- The patient's early discharge during the implementation phase of the research,
- The patient's inability to participate in the procedures due to changes in health status,
- Administration of a painkiller to the patient other than paracetamol 2*1 (intravenous) and dexketoprofen ampoules 2*1 (intravenous),
- The patient's transfer to another clinic.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Yildirim Beyazit University, Faculty of Health Sciences, Department of Nursing
Ankara
About this study
Official title: The Effect of Music on Pain During Drain Removal in Patients Undergoing Total Knee Arthroplasty
This research was conducted as a randomized controlled experimental study to examine the effect of music listening during drain removal on pain in patients undergoing total knee arthroplasty. The study was carried out between March 19, 2024, and October 15, 2025, in the orthopedics and traumatology clinic of a state hospital in Türkiye. The sample consisted of 60 adult patients. Patients were randomly divided into intervention and control groups. Patients in the intervention group were played the Acemaşiran Maqam of Turkish Classical MP3 music, prepared by the group of Turkish Music Research and Promotion (TÜMATA) in Türkiye, via headphones for a total of 30 minutes, starting 15 minutes before and continuing for 15 minutes after drain removal. Patients in the control group received no intervention. Before the drain removal procedure, the "Patient Demographic Characteristic Form" including the sociodemographic characteristics of the patients and the VAS pain scale were completed by the researcher through face-to-face interviews. Pain levels of patients were re-evaluated using the Visual Analog Scale (VAS) pain scale immediately after, and 15 minutes after drain removal. The study expected that patients in the intervention group will have more favorable pain scores compared to the control group. It is believed that the results of this research will contribute to the literature.
Read the detailed description
This research was conducted as a randomized controlled experimental study to examine the effect of music listening during drain removal on pain in patients undergoing total knee arthroplasty. The study was carried out between March 19, 2024, and October 15, 2025, in the orthopedics and traumatology clinic of a state hospital in Türkiye. Written permission was obtained from the Clinical Research Ethics Committee of a state university in Türkiye to conduct the research (Decision No: 2023-KAEK-30). The sample size was calculated using the group*time interaction (mixed ANOVA) module in repeated measures in the G-Power Version 3.1.9.6 program (Franz Faul, Germany). It was determined that a minimum of 44 patients (22 in each group) were required to determine the change before, after, and at 15 minutes in the intervention and control groups with 95% power, 0.05 type I error, and at least f=0.25 (moderate) effect size. To increase the power of the study, a total of 60 patients were included, with 30 in the intervention group and 30 in the control group. The study sample consisted of patients who volunteered and provided written consent. Patients who met the inclusion criteria and agreed to participate in the study were randomly assigned to the intervention and control groups. In the randomization process, participants were given sealed envelopes containing the names of the intervention and control groups, and the patient was asked to choose between the two envelopes. The patients were assigned to either the intervention or control group according to their choice. First, the researcher had the patients complete a "Patient Demographic Characteristic Form" containing sociodemographic characteristics (age, gender, marital status, education level, etc.) and the VAS pain scale through face-to-face interviews. The patients' drains were removed by their physician on the second postoperative day according to the procedure. Patients undergoing total knee arthroplasty received routine pain relief treatment with paracetamol vial 2*1 (intravenous) (08:00-20:00) and dexketoprofen ampoule 2*1 (intravenous) (12:00-24:00). Drain removal was performed after the patients received their paracetamol vial (intravenous) treatment in the morning. Fifteen minutes before drain removal in the intervention group, the researcher played the Acemaşiran maqam of Turkish Classical Music, MP3 through headphones, prepared by the group of Turkish Music Research and Promotion (TÜMATA), which is known in the literature (Özdemir et al., 2019; Çelebi et al., 2020) to have positive effects on pain and physiological parameters and provides relaxation. The ear headphones were disinfected with a 70% alcohol solution before being used between patients. Music was listened for a total of 30 minutes, continuing before 15 minutes and after 15 minutes of drain removal (Yarahmadi et al., 2018). Pain levels were assessed again using the VAS pain scale immediately after, and 15 minutes after drain removal. Patients in the control group received no intervention. Pain levels in the control group were also assessed using the VAS pain scale 15 minutes before, immediately after, and 15 minutes after drain removal. Pain assessment of all patients was performed by another nurse independent of the study to avoid bias.
- Conditions
- Music Intervention
- Being tested
- Music intervention
- Keywords
- Nursing, Pain, Music, Total knee arthroplasty
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music interventionOther
Also called Music
Fifteen minutes before drain removal in the intervention group, the researcher played the music MP3 through headphones. The ear headphones were disinfected with a 70% alcohol solution before being used between patients. Music was played for a total of 30 minutes, continuing before 15 minutes and after 15 minutes of drain removal.
| Study group | Role | What they receive |
|---|---|---|
| Music Intervention | Experimental | Patients in this group were given 30 minutes of music via MP3 headphones, starting 15 minutes before drain removal and continuing for 15 minutes after. Pain levels in the intervention group were assessed using the VAS pain scale 15 minutes before, immediately after, and 15 minutes after drain removal. Receives: Other: Music intervention |
| Control | No intervention | Patients in the control group received no intervention. Pain levels in the control group were also assessed using the VAS pain scale 15 minutes before, immediately after, and 15 minutes after drain removal. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain during drain removal in patients undergoing Total Knee Arthroplasty
In this study, a Visual Analog Scale (VAS) was used to assess patients' pain. This scale includes a 10 cm ruler. Patients were asked to rate the pain they felt during the procedure on a scale of 1 to 10. Patients gave a score of "0" if they felt no pain and "10" if they felt unbearable pain. Patients were asked to rate the pain they felt on the VAS scale 15 minutes before, immediately after, and 15 minutes after the drain removal. At the end of the study, the scale results will be compared and evaluated for both groups.
Measured: 7 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start19 Mar 2024
- Primary completion19 Apr 2024
- Study completion15 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Music InterventionStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This research is a randomized controlled experimental study. The study was conducted on adult patients who underwent total knee arthroplasty at the orthopedics and traumatology clinic of a state hospital in Türkiye, and who met the research criteria and volunteered to participate. Data were collected between March 19, 2024, and October 15, 2025. Data were collected using a "Patient Demographic Characteristic Form" and the VAS pain scale. The researcher informed the volunteer patients about the study and obtained their written informed consent. Drain removal was performed by the patient's own physician, and music was listened by the researcher. After the procedure was completed, the patients' pain levels were scored on a scale by a nurse independent of the research to avoid bias.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ebru Erek Kazan, Study director, Ankara Yildirim Beyazit University, Faculty of Health Sciences, Department of Nursing, Esenboga Campus, Cubuk/Ankara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07916454
- Sponsor's protocol ID
- 2026-01
- Status last verified
- Oct 2026
- First submitted
- 30 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Music on Pain During Drain Removal in Patients Undergoing Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT07916454
- Acronym / sponsor ID
- 2026-01
- Conditions
- Music Intervention
- Keywords
- Nursing, Pain, Music, Total knee arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 19 Mar 2024 (actual)
- Primary completion
- 19 Apr 2024 (actual)
- Study completion
- 15 Oct 2025 (actual)
- First posted
- 4 Nov 2026 (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.
This research was conducted as a randomized controlled experimental study to examine the effect of music listening during drain removal on pain in patients undergoing total knee arthroplasty. The study was carried out between March 19, 2024, and October 15, 2025, in the orthopedics and traumatology clinic of a state hospital in Türkiye. The sample consisted of 60 adult patients. Patients were randomly divided into intervention and control groups. Patients in the intervention group were played the Acemaşiran Maqam of Turkish Classical MP3 music, prepared by the group of Turkish Music Research and Promotion (TÜMATA) in Türkiye, via headphones for a total of 30 minutes, starting 15 minutes before and continuing for 15 minutes after drain removal. Patients in the control group received no intervention. Before the drain removal procedure, the "Patient Demographic Characteristic Form" including the sociodemographic characteristics of the patients and the VAS pain scale were completed by the researcher through face-to-face interviews. Pain levels of patients were re-evaluated using the Visual Analog Scale (VAS) pain scale immediately after, and 15 minutes after drain removal. The study expected that patients in the intervention group will have more favorable pain scores compared to the control group. It is believed that the results of this research will contribute to the literature.
Detailed description
This research was conducted as a randomized controlled experimental study to examine the effect of music listening during drain removal on pain in patients undergoing total knee arthroplasty. The study was carried out between March 19, 2024, and October 15, 2025, in the orthopedics and traumatology clinic of a state hospital in Türkiye. Written permission was obtained from the Clinical Research Ethics Committee of a state university in Türkiye to conduct the research (Decision No: 2023-KAEK-30). The sample size was calculated using the group*time interaction (mixed ANOVA) module in repeated measures in the G-Power Version 3.1.9.6 program (Franz Faul, Germany). It was determined that a minimum of 44 patients (22 in each group) were required to determine the change before, after, and at 15 minutes in the intervention and control groups with 95% power, 0.05 type I error, and at least f=0.25 (moderate) effect size. To increase the power of the study, a total of 60 patients were included, with 30 in the intervention group and 30 in the control group. The study sample consisted of patients who volunteered and provided written consent. Patients who met the inclusion criteria and agreed to participate in the study were randomly assigned to the intervention and control groups. In the randomization process, participants were given sealed envelopes containing the names of the intervention and control groups, and the patient was asked to choose between the two envelopes. The patients were assigned to either the intervention or control group according to their choice. First, the researcher had the patients complete a "Patient Demographic Characteristic Form" containing sociodemographic characteristics (age, gender, marital status, education level, etc.) and the VAS pain scale through face-to-face interviews. The patients' drains were removed by their physician on the second postoperative day according to the procedure. Patients undergoing total knee arthroplasty received routine pain relief treatment with paracetamol vial 2*1 (intravenous) (08:00-20:00) and dexketoprofen ampoule 2*1 (intravenous) (12:00-24:00). Drain removal was performed after the patients received their paracetamol vial (intravenous) treatment in the morning. Fifteen minutes before drain removal in the intervention group, the researcher played the Acemaşiran maqam of Turkish Classical Music, MP3 through headphones, prepared by the group of Turkish Music Research and Promotion (TÜMATA), which is known in the literature (Özdemir et al., 2019; Çelebi et al., 2020) to have positive effects on pain and physiological parameters and provides relaxation. The ear headphones were disinfected with a 70% alcohol solution before being used between patients. Music was listened for a total of 30 minutes, continuing before 15 minutes and after 15 minutes of drain removal (Yarahmadi et al., 2018). Pain levels were assessed again using the VAS pain scale immediately after, and 15 minutes after drain removal. Patients in the control group received no intervention. Pain levels in the control group were also assessed using the VAS pain scale 15 minutes before, immediately after, and 15 minutes after drain removal. Pain assessment of all patients was performed by another nurse independent of the study to avoid bias.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This research is a randomized controlled experimental study. The study was conducted on adult patients who underwent total knee arthroplasty at the orthopedics and traumatology clinic of a state hospital in Türkiye, and who met the research criteria and volunteered to participate. Data were collected between March 19, 2024, and October 15, 2025. Data were collected using a "Patient Demographic Characteristic Form" and the VAS pain scale. The researcher informed the volunteer patients about the study and obtained their written informed consent. Drain removal was performed by the patient's own physician, and music was listened by the researcher. After the procedure was completed, the patients' pain levels were scored on a scale by a nurse independent of the research to avoid bias.
| Arm | Type | Receives |
|---|---|---|
| Music Intervention | Experimental | Other: Music interventionPatients in this group were given 30 minutes of music via MP3 headphones, starting 15 minutes before drain removal and continuing for 15 minutes after. Pain levels in the intervention group were assessed using the VAS pain scale 15 minutes before, immediately after, and 15 minutes after drain removal. |
| Control | No intervention | –Patients in the control group received no intervention. Pain levels in the control group were also assessed using the VAS pain scale 15 minutes before, immediately after, and 15 minutes after drain removal. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 18 and over,
- Who do not have any psychiatric disorders,
- Who can speak and read Turkish,
- Who do not have visual or hearing impairments and
- Who volunteered to participate in the study were included.
Key exclusion criteria (6 listed)
- The patient's voluntary withdrawal from the study,
- Removing the ear headphones during the procedure,
- The patient's early discharge during the implementation phase of the research,
- The patient's inability to participate in the procedures due to changes in health status,
- Administration of a painkiller to the patient other than paracetamol 2*1 (intravenous) and dexketoprofen ampoules 2*1 (intravenous),
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 |
|---|---|---|
| Music interventionAlso: MusicFifteen minutes before drain removal in the intervention group, the researcher played the music MP3 through headphones. The ear headphones were disinfected with a 70% alcohol solution before being used between patients. Music was played for a total of 30 minutes, continuing before 15 minutes and after 15 minutes of drain removal. | Other | Music Intervention |
Primary outcome
Pain during drain removal in patients undergoing Total Knee Arthroplasty
Time frame: 7 month
In this study, a Visual Analog Scale (VAS) was used to assess patients' pain. This scale includes a 10 cm ruler. Patients were asked to rate the pain they felt during the procedure on a scale of 1 to 10. Patients gave a score of "0" if they felt no pain and "10" if they felt unbearable pain. Patients were asked to rate the pain they felt on the VAS scale 15 minutes before, immediately after, and 15 minutes after the drain removal. At the end of the study, the scale results will be compared and evaluated for both groups.
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 6 Nov 2026.
- Individual participant dataSharing planned: No
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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.
Ebru Erek Kazan study director
Ankara Yildirim Beyazit University, Faculty of Health Sciences, Department of Nursing, Esenboga Campus, Cubuk/Ankara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music intervention in people with Music Intervention, run by Ankara Yildirim Beyazıt 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 5 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 6 Nov 2026. 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 during drain removal in patients undergoing Total Knee Arthroplasty (time frame: 7 month). 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 6 Nov 2026.