Benign Prostatic HyperplasiaAEEP-MUSICNCT07255118
Music Intervention During AEEP: A Prospective Randomized Controlled Trial
A study testing Music intervention in people with Benign Prostatic Hyperplasia and Anxiety, run by İrfan Şafak Barlas at 1 site in Turkey (Türkiye).
Trial summary
This prospective randomized controlled study investigates the effect of perioperative music listening on anxiety and postoperative pain in patients undergoing Anatomical Endoscopic Enucleation of the Prostate (AEEP) for benign prostatic hyperplasia. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia, Anxiety, Postoperative Pain Management
- What is being tested?
- Music intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 1 Mar 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 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male patients aged ≥40 years
- patients who underwent surgery under regional anesthesia without sedation
- patients who did not benefit from medical treatment for BPO
- preoperative International Prostate Symptom Score (IPSS) >19
- preoperative maximum urine flow rate (Qmax) <15 mL/sec
- post-voiding residual volume (PVR) >50 mL.
Who cannot join
- patients with urethral stricture
- patients who underwent urological treatments other than laser enucleation of the prostate
- patients with urinary tract infections and/or hematuria
- patients with urinary system malignancy
- patients with a history of previous prostate surgery
- patients with neurogenic bladder
- patients with hearing impairment
- patients with psychiatric disorders or those using medications prescribed by a psychiatrist.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Acibadem Ankara Hospital
Ankara, Ankara, 06550
About this study
Official title: Effect of Music Intervention on Anxiety and Pain After Anatomical Endoscopic Enucleation of the Prostate: A Prospective Randomized Controlled Trial
This prospective randomized controlled study investigates the effect of perioperative music listening on anxiety and postoperative pain in patients undergoing Anatomical Endoscopic Enucleation of the Prostate (AEEP) for benign prostatic hyperplasia. A total of 135 patients were randomized into two parallel groups: 67 patients listened to relaxing instrumental music during the perioperative period, while 68 patients received standard care without music. Anxiety was assessed using the State Anxiety Inventory (SAI) immediately before surgery and 2 hours postoperatively, and pain was evaluated using the Visual Analog Scale (VAS) at the postoperative 2nd hour. The study aims to determine whether a simple, non-pharmacological behavioral intervention can improve perioperative patient comfort and recovery outcomes in endoscopic prostate surgery.
Read the detailed description
Benign prostatic hyperplasia (BPH) is one of the most common urological conditions in aging men, often requiring surgical intervention when medical therapy fails. Anatomical Endoscopic Enucleation of the Prostate (AEEP) has emerged as an effective and tissue-preserving surgical approach for managing BPH. Despite the minimally invasive nature of AEEP, perioperative anxiety and postoperative pain remain important determinants of patient comfort, satisfaction, and overall recovery.
Music listening is a simple, inexpensive, and non-pharmacological behavioral intervention that has been shown in various surgical disciplines to reduce anxiety, modulate pain perception, and improve patient experience. However, its potential benefits during AEEP have not been previously explored.
In this prospective randomized controlled trial, we evaluated the effect of perioperative music exposure on anxiety and acute postoperative pain among patients undergoing AEEP. A total of 135 male patients scheduled for AEEP were enrolled and randomized into two groups:
Music Group (n = 67): Patients listened to standardized relaxing instrumental music via headphones starting immediately before anesthesia induction and continuing during the procedure.
Control Group (n = 68): Patients received routine perioperative care without exposure to music.
Perioperative anxiety was measured using the State Anxiety Inventory (SAI) at two predefined time points: immediately before surgery and at the postoperative 2nd hour. Postoperative pain intensity was assessed using the Visual Analog Scale (VAS) 2 hours after the procedure. All surgical and anesthetic techniques were standardized across groups to minimize variability.
This study aims to determine whether perioperative music listening can serve as an effective adjunctive intervention to improve psychological well-being and reduce pain in patients undergoing AEEP. Findings from this research may support the integration of music into perioperative care pathways, offering a safe and easily applicable strategy to enhance patient-centered outcomes in endoscopic prostate surgery.
- Being tested
- Music intervention
- Keywords
- AEEP, Music type, Postopertive comfort, State Anxiety Inventory, Visual Analog Scale
- Medical subject headings
- Prostatic Hyperplasia, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music interventionBehavioural
Patients listened to relaxing instrumental music beginning immediately before anesthesia induction and continuing throughout the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Music Group | Experimental | Participants undergoing AEEP who listened to standardized relaxing instrumental music via headphones during the perioperative period. Receives: Behavioral: Music intervention |
| Control Group (No Music) | No intervention | Participants undergoing AEEP who received standard perioperative care without exposure to music. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in State Anxiety Inventory (SAI) Score
Perioperative anxiety will be measured using the State Anxiety Inventory (SAI) at two time points: immediately before surgery (baseline) and at 2 hours postoperatively. The outcome represents the change in SAI score between these two assessments.
Measured: From baseline (immediately before surgery) to postoperative 2nd hour.
Secondary outcomes (1)
Postoperative Pain Score Assessed by Visual Analog Scale (VAS)
Pain intensity will be evaluated using a 0-10 Visual Analog Scale (VAS) at the postoperative 2nd hour.
Measured: Postoperative 2nd hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start1 Sep 2023
- Primary completion1 Jan 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Benign Prostatic HyperplasiaStudies 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
- Model description
- Participants were randomly assigned to one of two parallel groups: a music intervention group receiving perioperative music listening via headphones, and a control group receiving standard perioperative care without music. Each participant received only the intervention allocated to his assigned group, and outcomes were compared between the two independent groups.
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- İrfan Şafak Barlas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, İrfan Şafak Barlas, Acibadem University
- Investigators
- Irfan Safak Barlas, Urology Specialist, Principal investigator, Acibadem Ankara Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07255118
- Sponsor's protocol ID
- 2023-10/425
- Acronym
- AEEP-MUSIC
- Status last verified
- Jan 2025
- First submitted
- 20 Nov 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the study is single-center, minimal-risk, and the dataset contains sensitive clinical information that cannot be fully de-identified in a reliable manner.
Publications
Barlas IS, Yilmaz M, Aybal HC, Duvarci M, Guven S, Tunc L. Effect of music intervention on anxiety and pain after anatomical endoscopic enucleation of the prostate: a prospective randomized controlled trial. BMC Urol. 2026 Jun 11. doi: 10.1186/s12894-026-02223-0. Online ahead of print.
PubMed 42271365
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Music Intervention on Anxiety and Pain After Anatomical Endoscopic Enucleation of the Prostate: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07255118
- Acronym / sponsor ID
- AEEP-MUSIC / 2023-10/425
- Keywords
- AEEP, Music type, Postopertive comfort, State Anxiety Inventory, Visual Analog Scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- İrfan Şafak BarlasUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 28 Nov 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.
This prospective randomized controlled study investigates the effect of perioperative music listening on anxiety and postoperative pain in patients undergoing Anatomical Endoscopic Enucleation of the Prostate (AEEP) for benign prostatic hyperplasia. A total of 135 patients were randomized into two parallel groups: 67 patients listened to relaxing instrumental music during the perioperative period, while 68 patients received standard care without music. Anxiety was assessed using the State Anxiety Inventory (SAI) immediately before surgery and 2 hours postoperatively, and pain was evaluated using the Visual Analog Scale (VAS) at the postoperative 2nd hour. The study aims to determine whether a simple, non-pharmacological behavioral intervention can improve perioperative patient comfort and recovery outcomes in endoscopic prostate surgery.
Detailed description
Benign prostatic hyperplasia (BPH) is one of the most common urological conditions in aging men, often requiring surgical intervention when medical therapy fails. Anatomical Endoscopic Enucleation of the Prostate (AEEP) has emerged as an effective and tissue-preserving surgical approach for managing BPH. Despite the minimally invasive nature of AEEP, perioperative anxiety and postoperative pain remain important determinants of patient comfort, satisfaction, and overall recovery.
Music listening is a simple, inexpensive, and non-pharmacological behavioral intervention that has been shown in various surgical disciplines to reduce anxiety, modulate pain perception, and improve patient experience. However, its potential benefits during AEEP have not been previously explored.
In this prospective randomized controlled trial, we evaluated the effect of perioperative music exposure on anxiety and acute postoperative pain among patients undergoing AEEP. A total of 135 male patients scheduled for AEEP were enrolled and randomized into two groups:
Music Group (n = 67): Patients listened to standardized relaxing instrumental music via headphones starting immediately before anesthesia induction and continuing during the procedure.
Control Group (n = 68): Patients received routine perioperative care without exposure to music.
Perioperative anxiety was measured using the State Anxiety Inventory (SAI) at two predefined time points: immediately before surgery and at the postoperative 2nd hour. Postoperative pain intensity was assessed using the Visual Analog Scale (VAS) 2 hours after the procedure. All surgical and anesthetic techniques were standardized across groups to minimize variability.
This study aims to determine whether perioperative music listening can serve as an effective adjunctive intervention to improve psychological well-being and reduce pain in patients undergoing AEEP. Findings from this research may support the integration of music into perioperative care pathways, offering a safe and easily applicable strategy to enhance patient-centered outcomes in endoscopic prostate surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to one of two parallel groups: a music intervention group receiving perioperative music listening via headphones, and a control group receiving standard perioperative care without music. Each participant received only the intervention allocated to his assigned group, and outcomes were compared between the two independent groups.
| Arm | Type | Receives |
|---|---|---|
| Music Group | Experimental | Behavioral: Music interventionParticipants undergoing AEEP who listened to standardized relaxing instrumental music via headphones during the perioperative period. |
| Control Group (No Music) | No intervention | –Participants undergoing AEEP who received standard perioperative care without exposure to music. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- male patients aged ≥40 years
- patients who underwent surgery under regional anesthesia without sedation
- patients who did not benefit from medical treatment for BPO
- preoperative International Prostate Symptom Score (IPSS) >19
- preoperative maximum urine flow rate (Qmax) <15 mL/sec
Key exclusion criteria (8 listed)
- patients with urethral stricture
- patients who underwent urological treatments other than laser enucleation of the prostate
- patients with urinary tract infections and/or hematuria
- patients with urinary system malignancy
- patients with a history of previous prostate surgery
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 interventionPatients listened to relaxing instrumental music beginning immediately before anesthesia induction and continuing throughout the procedure. | Behavioural | Music Group |
Primary outcome
Change in State Anxiety Inventory (SAI) Score
Time frame: From baseline (immediately before surgery) to postoperative 2nd hour.
Perioperative anxiety will be measured using the State Anxiety Inventory (SAI) at two time points: immediately before surgery (baseline) and at 2 hours postoperatively. The outcome represents the change in SAI score between these two assessments.
1 secondary outcome
Postoperative Pain Score Assessed by Visual Analog Scale (VAS)
Time frame: Postoperative 2nd hour.
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 28 Nov 2025.
- Derived from this study: PubMed 42271365Barlas IS, Yilmaz M, Aybal HC, Duvarci M, Guven S, Tunc L. Effect of music intervention on anxiety and pain after anatomical endoscopic enucleation of the prostate: a prospective randomized controlled trial. BMC Urol. 2026 Jun 11. doi: 10.1186/s12894-026-02223-0. Online ahead of print.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the study is single-center, minimal-risk, and the dataset contains sensitive clinical information that cannot be fully de-identified in a reliable manner.
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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.
Irfan Safak Barlas, Urology Specialist principal investigator
Acibadem Ankara Hospital
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 Benign Prostatic Hyperplasia and Anxiety, run by İrfan Şafak Barlas 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 6 inclusion and 8 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 28 Nov 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?
Change in State Anxiety Inventory (SAI) Score (time frame: From baseline (immediately before surgery) to postoperative 2nd hour.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07255118, which also lists 1 linked publication.
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 28 Nov 2025; AzTrials last refreshed its copy on 30 Oct 2026.