CataractNCT07767643
Personalized Music for Anxiety During Cataract Surgery
A study testing Structured Personalized Music Intervention in people with Cataract and Anxiety, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial evaluated the effect of a personalized music intervention on anxiety and pain in patients undergoing cataract surgery under local anesthesia. A total of 100 patients were randomly assigned to an intervention group or a control group. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- What is being tested?
- Structured Personalized Music Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Sep 2023to 6 May 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 40-75 years
- Able to read and write
- Able to speak and understand Turkish
- No psychiatric or neurological diagnosis that could affect pain or anxiety
- Willing to participate in the study
Who cannot join
- Communication problems
- Communication impairment
- Chronic pain
- Psychiatric disorder
- Substance or alcohol dependence
- History of ear infection
Show all 9Show fewer
- Previous ocular surgery other than cataract surgery
- Mature cataract, traumatic cataract, or other conditions considered likely to prolong surgery or increase the risk of complications
- Complicated diabetes mellitus (polyneuropathy, diabetic retinopathy, or nephropathy) or HbA1c ≥8% (uncontrolled diabetes)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Music Selected According to Patients' Musical Preferences on Anxiety and Pain During Cataract Surgery
This randomized controlled trial evaluated the effect of a personalized music intervention on anxiety and pain in patients undergoing cataract surgery under local anesthesia. A total of 100 patients were randomly assigned to an intervention group or a control group. Patients in the intervention group received a structured personalized music intervention during surgery based on their musical preferences, while patients in the control group received standard care. Anxiety was assessed before and immediately after surgery using the State-Trait Anxiety Inventory-State (STAI-S), and pain was assessed immediately after surgery and two hours after surgery using the Visual Analog Scale (VAS). The study aimed to determine whether personalized music provided during cataract surgery could reduce patients' anxiety and pain compared with standard care.
- Being tested
- Structured Personalized Music Intervention
- Keywords
- Cataract Surgery, Personalized Music, Music Intervention, Anxiety, Pain, Perioperative Nursing
- Medical subject headings
- Cataract, Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Personalized Music InterventionBehavioural
Participants received a structured personalized music intervention during cataract surgery. Music was individualized according to participant preferences using a structured assessment of music preferences. Instrumental music with a tempo of approximately 60-100 beats per minute was selected and delivered in the operating room for approximately 30 minutes during surgery, in addition to standard perioperative care.
| Study group | Role | What they receive |
|---|---|---|
| Personalized Music Intervention Group | Experimental | Participants assigned to this arm received a structured personalized music intervention during cataract surgery in addition to standard perioperative care. The music intervention was individualized based on participant preferences and delivered intraoperatively for approximately 30 minutes. Receives: Behavioral: Structured Personalized Music Intervention |
| Control Group | No intervention | Participants assigned to this arm received standard perioperative care for cataract surgery without the structured personalized music intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
State Anxiety Level Assessed Using the State-Trait Anxiety Inventory-State (STAI-S)
State anxiety was assessed using the 20-item State-Trait Anxiety Inventory-State (STAI-S), with total scores ranging from 20 to 80. Higher scores indicate greater levels of state anxiety. STAI-S was administered approximately 1 hour before surgery and immediately after surgery to evaluate perioperative state anxiety.
Measured: Approximately 1 hour before surgery and immediately after surgery
Secondary outcomes (1)
Pain Intensity Assessed Using the Visual Analog Scale (VAS)
Pain intensity was assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst possible pain), with higher scores indicating greater pain intensity. Pain was assessed immediately after surgery and 2 hours after surgery to evaluate postoperative pain.
Measured: Immediately after surgery and 2 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start11 Sep 2023
- Primary completion6 May 2024
- Study completion6 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- More trials run by Ege 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, kübra yiğit gökbel, Ege University
- Investigators
- Kübra Yigit Gökbel, MSc, Principal investigator, Ege University, Faculty of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07767643
- Sponsor's protocol ID
- 230071
- Status last verified
- Aug 2026
- First submitted
- 12 Aug 2026
- Last updated
- 19 Aug 2026
- 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 data sharing was not included in the original study protocol or informed consent process.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Music Selected According to Patients' Musical Preferences on Anxiety and Pain During Cataract Surgery
- ClinicalTrials.gov ID
- NCT07767643
- Acronym / sponsor ID
- 230071
- Keywords
- Cataract Surgery, Personalized Music, Music Intervention, Anxiety, Pain, Perioperative Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 11 Sep 2023 (actual)
- Primary completion
- 6 May 2024 (actual)
- Study completion
- 6 May 2024 (actual)
- First posted
- 17 Aug 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 randomized controlled trial evaluated the effect of a personalized music intervention on anxiety and pain in patients undergoing cataract surgery under local anesthesia. A total of 100 patients were randomly assigned to an intervention group or a control group. Patients in the intervention group received a structured personalized music intervention during surgery based on their musical preferences, while patients in the control group received standard care. Anxiety was assessed before and immediately after surgery using the State-Trait Anxiety Inventory-State (STAI-S), and pain was assessed immediately after surgery and two hours after surgery using the Visual Analog Scale (VAS). The study aimed to determine whether personalized music provided during cataract surgery could reduce patients' anxiety and pain compared with standard care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalized Music Intervention Group | Experimental | Behavioral: Structured Personalized Music InterventionParticipants assigned to this arm received a structured personalized music intervention during cataract surgery in addition to standard perioperative care. The music intervention was individualized based on participant preferences and delivered intraoperatively for approximately 30 minutes. |
| Control Group | No intervention | –Participants assigned to this arm received standard perioperative care for cataract surgery without the structured personalized music intervention. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 40-75 years
- Able to read and write
- Able to speak and understand Turkish
- No psychiatric or neurological diagnosis that could affect pain or anxiety
- Willing to participate in the study
Key exclusion criteria (9 listed)
- Communication problems
- Communication impairment
- Chronic pain
- Psychiatric disorder
- Substance or alcohol dependence
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 |
|---|---|---|
| Structured Personalized Music InterventionParticipants received a structured personalized music intervention during cataract surgery. Music was individualized according to participant preferences using a structured assessment of music preferences. Instrumental music with a tempo of approximately 60-100 beats per minute was selected and delivered in the operating room for approximately 30 minutes during surgery, in addition to standard perioperative care. | Behavioural | Personalized Music Intervention Group |
Primary outcome
State Anxiety Level Assessed Using the State-Trait Anxiety Inventory-State (STAI-S)
Time frame: Approximately 1 hour before surgery and immediately after surgery
State anxiety was assessed using the 20-item State-Trait Anxiety Inventory-State (STAI-S), with total scores ranging from 20 to 80. Higher scores indicate greater levels of state anxiety. STAI-S was administered approximately 1 hour before surgery and immediately after surgery to evaluate perioperative state anxiety.
1 secondary outcome
Pain Intensity Assessed Using the Visual Analog Scale (VAS)
Time frame: Immediately after surgery and 2 hours after surgery
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 19 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because data sharing was not included in the original study protocol or informed consent process.
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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.
Kübra Yigit Gökbel, MSc principal investigator
Ege University, Faculty of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Personalized Music Intervention in people with Cataract and Anxiety, run by Ege 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 9 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 19 Aug 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?
State Anxiety Level Assessed Using the State-Trait Anxiety Inventory-State (STAI-S) (time frame: Approximately 1 hour before surgery and immediately after surgery). 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 19 Aug 2026.