CataractNCT06555770
Effects of Music and Stress Ball Application on Patients During Cataract Surgery
A study testing Music intervention and Stress ball in people with Cataract and Nursing Caries, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
Cataract is one of the leading causes of preventable blindness in the world and in Türkiye. Cataract surgery is one of the most frequently performed and most reliable surgeries for eye diseases. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract, Nursing Caries
- What is being tested?
- Music intervention and Stress ball
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Aug 2024to 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being 18 years of age or older
- Not having any hearing or perception problems,
- Absence of any condition preventing the use of a stress ball (e.g. Parkinson's disease, arthritis, fractures),
- Having undergone cataract surgery for the first time,
- Being willing to participate in the research.
Who cannot join
- Any use of any analgesic or anxiolytic within 24 hours prior to surgery,
- Transition from topical to general anesthesia during surgery,
- Uncontrolled hypertension
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Music and Stress Ball Application on Patients During Cataract Surgery Examining the Effect on Anxiety and Pain
Cataract is one of the leading causes of preventable blindness in the world and in Türkiye. Cataract surgery is one of the most frequently performed and most reliable surgeries for eye diseases. Advances in anesthesia and surgical techniques make it possible for most cataract surgery procedures to be performed under topical anesthetic.
Read the detailed description
This success greatly reduces the duration of surgery, and the side effects associated with local or general anesthesia. However, despite the sedation that can be administered before and during surgery (e.g. benzodiazepines and opioids), patients can experience significant anxiety along with a certain degree of pain and discomfort during surgery. Anxiety causes stress that causes the cardiovascular system to respond by activating the sympathetic nervous system, which causes an increase in heart rate and blood pressure (BP) levels. These mechanisms can complicate the surgical procedure due to increased intraocular pressure. Hypertension and tachycardia above 85 discharges per minute represent an increased risk of orbital bleeding during local anesthetic injection and potential perioperative supracoroidal expulsive bleeding. The sequence and pre-operative music intervention is to be an inexpensive, easy-to-implement technique that has no side effects, has no significant beneficial effects on the anxiety of patients in different surgical populations. Also, music intervention allows for better patient co-operation during surgery under topical anesthesia and a drop in intraoperative blood pressure. Another method that is effective in reducing anxiety and pain is the stress ball. The stress ball is usually a soft toy that is not greater than 7 cm, gets stuck, relieving stress and muscle tension, or manipulated with fingers for exercising the muscles. One of the methods of distracting attention, the stress ball is an effective way of ensuring cognitive focus. The stress ball method has been used to reduce patients' anxiety and pain. Stretching the stress ball during surgery increases the feeling of strength, allowing patients to have direct control over the object. In this way, surgical intervention has a positive effect on anxiety and patient satisfaction without intervention. While the literature includes studies involving the combination of stress ball use and music intervention on surgical patients, there is no research involving combined use of music and stress ball application in cataract surgery in a single study. The investigators work therefore contributes to literature.
- Conditions
- Cataract, Nursing Caries
- Being tested
- Music intervention, Stress ball
- Keywords
- cataract, music intervention, stress ball, pain, anxiety
- Medical subject headings
- Cataract, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music interventionBehavioural
Patients assigned to the music intervention group will select their preferred music from a prepared playlist. The selected music will be played for 15 minutes during cataract surgery.
Stress ballBehavioural
Patients assigned to the stress ball group will be instructed to squeeze the stress ball with both hands, count to five while squeezing, and repeat the exercise. The stress ball will be used for 15 minutes during cataract surgery.
| Study group | Role | What they receive |
|---|---|---|
| Stress ball | Experimental | Pain will be assessed using the Visual Analog Scale (VAS) immediately after surgery and approximately 10 minutes after transfer to the ward. State anxiety will be assessed using the Visual Analog Scale for Anxiety (VAS-A) preoperatively, immediately after surgery while the patient remains on the operating table, and approximately 10 minutes after transfer to the ward. Trait anxiety will be assessed once preoperatively using the State-Trait Anxiety Inventory (STAI-II). Patients assigned to the stress ball group will be instructed to squeeze the stress ball with both hands, count to five while squeezing, and repeat the exercise. The stress ball will be used for 15 minutes during cataract surgery. Patients will be reminded during the procedure to continue the intervention as instructed. Receives: Behavioral: Stress ball |
| Music intervention | Experimental | Pain will be assessed using the Visual Analog Scale (VAS) immediately after surgery and approximately 10 minutes after transfer to the ward. State anxiety will be assessed using the Visual Analog Scale for Anxiety (VAS-A) preoperatively, immediately after surgery while the patient remains on the operating table, and approximately 10 minutes after transfer to the ward. Trait anxiety will be assessed once preoperatively using the State-Trait Anxiety Inventory (STAI-II). According to the randomization, patients assigned to the music intervention group will be asked to select their preferred music from a prepared playlist. The playlist will include 50 tracks representing pop music, Turkish classical music, regional folk music, instrumental music, and religious music. The selected music will be played for 15 minutes during cataract surgery. Receives: Behavioral: Music intervention |
| Control | No intervention | Pain levels will be tested with VAS 10 minutes before the surgery, and anxiety levels with the VAS-A and Spielberg Continuous Anxiety Scale. The patient in the control group will not be given any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain (Visual Analog Scale)
Grading is made with a 10 cm long horizontal or vertical ruler on the scale and "0" means no pain and "10" means the most severe pain.
The patient marks the intensity of pain he feels on the ruler. If the marked value is between 1-4, it indicates mild pain, between 5-6 indicates moderate pain, and between 7-10 indicates severe pain.
In the application, the patient was asked to mark the intensity of pain he felt on the ruler and the value was measured and recorded.
Measured: Immediately after surgery
Pain (Visual Analog Scale)
Grading is made with a 10 cm long horizontal or vertical ruler on the scale and "0" means no pain and "10" means the most severe pain.
The patient marks the intensity of pain he feels on the ruler. If the marked value is between 1-4, it indicates mild pain, between 5-6 indicates moderate pain, and between 7-10 indicates severe pain.
In the application, the patient was asked to mark the intensity of pain he felt on the ruler and the value was measured and recorded.
Measured: 10 minutes after surgery
Anxiety (Visual Analog Scale-Anxiety)
Patients' anxiety will be evaluated (0-10 point). Grading is made with a 10 cm long horizontal or vertical ruler on the scale and "0" means no anxiety and "10" means the most severe anxiety.
In the application, the patient was asked to mark the intensity of anxiety he felt on the ruler and the value was measured and recorded.
Measured: approximately 5-10 minutes before surgery
Anxiety (Visual Analog Scale-Anxiety)
Patients' anxiety will be evaluated (0-10 point). Grading is made with a 10 cm long horizontal or vertical ruler on the scale and "0" means no anxiety and "10" means the most severe anxiety.
In the application, the patient was asked to mark the intensity of anxiety he felt on the ruler and the value was measured and recorded.
Measured: Immediately after surgery
Anxiety (Visual Analog Scale-Anxiety)
Patients' anxiety will be evaluated (0-10 point). Grading is made with a 10 cm long horizontal or vertical ruler on the scale and "0" means no anxiety and "10" means the most severe anxiety.
In the application, the patient was asked to mark the intensity of anxiety he felt on the ruler and the value was measured and recorded.
Measured: 10 minutes after surgery
State-Trait Anxiety Inventory (STAI-II)
Trait anxiety will be assessed using the State-Trait Anxiety Inventory-II (STAI-II), which consists of 20 items and measures an individual's general tendency to experience anxiety. Higher scores indicate higher levels of trait anxiety.
Measured: Approximately 5-10 minutes before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start20 Aug 2024
- Primary completion1 Mar 2025
- Study completion1 Mar 2025
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 Akdeniz 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda Cansu Yeniğün, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06555770
- Sponsor's protocol ID
- 2490Akdeniz
- Status last verified
- Apr 2025
- First submitted
- 13 Aug 2024
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Music and Stress Ball Application on Patients During Cataract Surgery Examining the Effect on Anxiety and Pain
- ClinicalTrials.gov ID
- NCT06555770
- Acronym / sponsor ID
- 2490Akdeniz
- Conditions
- Cataract, Nursing Caries
- Keywords
- cataract, music intervention, stress ball, pain, anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 20 Aug 2024 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 15 Aug 2024 (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.
Cataract is one of the leading causes of preventable blindness in the world and in Türkiye. Cataract surgery is one of the most frequently performed and most reliable surgeries for eye diseases. Advances in anesthesia and surgical techniques make it possible for most cataract surgery procedures to be performed under topical anesthetic.
Detailed description
This success greatly reduces the duration of surgery, and the side effects associated with local or general anesthesia. However, despite the sedation that can be administered before and during surgery (e.g. benzodiazepines and opioids), patients can experience significant anxiety along with a certain degree of pain and discomfort during surgery. Anxiety causes stress that causes the cardiovascular system to respond by activating the sympathetic nervous system, which causes an increase in heart rate and blood pressure (BP) levels. These mechanisms can complicate the surgical procedure due to increased intraocular pressure. Hypertension and tachycardia above 85 discharges per minute represent an increased risk of orbital bleeding during local anesthetic injection and potential perioperative supracoroidal expulsive bleeding. The sequence and pre-operative music intervention is to be an inexpensive, easy-to-implement technique that has no side effects, has no significant beneficial effects on the anxiety of patients in different surgical populations. Also, music intervention allows for better patient co-operation during surgery under topical anesthesia and a drop in intraoperative blood pressure. Another method that is effective in reducing anxiety and pain is the stress ball. The stress ball is usually a soft toy that is not greater than 7 cm, gets stuck, relieving stress and muscle tension, or manipulated with fingers for exercising the muscles. One of the methods of distracting attention, the stress ball is an effective way of ensuring cognitive focus. The stress ball method has been used to reduce patients' anxiety and pain. Stretching the stress ball during surgery increases the feeling of strength, allowing patients to have direct control over the object. In this way, surgical intervention has a positive effect on anxiety and patient satisfaction without intervention. While the literature includes studies involving the combination of stress ball use and music intervention on surgical patients, there is no research involving combined use of music and stress ball application in cataract surgery in a single study. The investigators work therefore contributes to literature.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stress ball | Experimental | Behavioral: Stress ballPain will be assessed using the Visual Analog Scale (VAS) immediately after surgery and approximately 10 minutes after transfer to the ward. State anxiety will be assessed using the Visual Analog Scale for Anxiety (VAS-A) preoperatively, immediately after surgery while the patient remains on the operating table, and approximately 10 minutes after transfer to the ward. Trait anxiety will be assessed once preoperatively using the State-Trait Anxiety Inventory (STAI-II). Patients assigned to the stress ball group will be instructed to squeeze the stress ball with both hands, count to five while squeezing, and repeat the exercise. The stress ball will be used for 15 minutes during cataract surgery. Patients will be reminded during the procedure to continue the intervention as instructed. |
| Music intervention | Experimental | Behavioral: Music interventionPain will be assessed using the Visual Analog Scale (VAS) immediately after surgery and approximately 10 minutes after transfer to the ward. State anxiety will be assessed using the Visual Analog Scale for Anxiety (VAS-A) preoperatively, immediately after surgery while the patient remains on the operating table, and approximately 10 minutes after transfer to the ward. Trait anxiety will be assessed once preoperatively using the State-Trait Anxiety Inventory (STAI-II). According to the randomization, patients assigned to the music intervention group will be asked to select their preferred music from a prepared playlist. The playlist will include 50 tracks representing pop music, Turkish classical music, regional folk music, instrumental music, and religious music. The selected music will be played for 15 minutes during cataract surgery. |
| Control | No intervention | –Pain levels will be tested with VAS 10 minutes before the surgery, and anxiety levels with the VAS-A and Spielberg Continuous Anxiety Scale. The patient in the control group will not be given any intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Being 18 years of age or older
- Not having any hearing or perception problems,
- Absence of any condition preventing the use of a stress ball (e.g. Parkinson's disease, arthritis, fractures),
- Having undergone cataract surgery for the first time,
- Being willing to participate in the research.
Key exclusion criteria (3 listed)
- Any use of any analgesic or anxiolytic within 24 hours prior to surgery,
- Transition from topical to general anesthesia during surgery,
- Uncontrolled hypertension
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 assigned to the music intervention group will select their preferred music from a prepared playlist. The selected music will be played for 15 minutes during cataract surgery. | Behavioural | Music intervention |
| Stress ballPatients assigned to the stress ball group will be instructed to squeeze the stress ball with both hands, count to five while squeezing, and repeat the exercise. The stress ball will be used for 15 minutes during cataract surgery. | Behavioural | Stress ball |
Primary outcome
Pain (Visual Analog Scale)
Time frame: Immediately after surgery
Grading is made with a 10 cm long horizontal or vertical ruler on the scale and "0" means no pain and "10" means the most severe pain. The patient marks the intensity of pain he feels on the ruler. If the marked value is between 1-4, it indicates mild pain, between 5-6 indicates moderate pain, and between 7-10 indicates severe pain. In the application, the patient was asked to mark the intensity of pain he felt on the ruler and the value was measured and recorded.
Pain (Visual Analog Scale)
Time frame: 10 minutes after surgery
Grading is made with a 10 cm long horizontal or vertical ruler on the scale and "0" means no pain and "10" means the most severe pain. The patient marks the intensity of pain he feels on the ruler. If the marked value is between 1-4, it indicates mild pain, between 5-6 indicates moderate pain, and between 7-10 indicates severe pain. In the application, the patient was asked to mark the intensity of pain he felt on the ruler and the value was measured and recorded.
Anxiety (Visual Analog Scale-Anxiety)
Time frame: approximately 5-10 minutes before surgery
Patients' anxiety will be evaluated (0-10 point). Grading is made with a 10 cm long horizontal or vertical ruler on the scale and "0" means no anxiety and "10" means the most severe anxiety. In the application, the patient was asked to mark the intensity of anxiety he felt on the ruler and the value was measured and recorded.
Anxiety (Visual Analog Scale-Anxiety)
Time frame: Immediately after surgery
Patients' anxiety will be evaluated (0-10 point). Grading is made with a 10 cm long horizontal or vertical ruler on the scale and "0" means no anxiety and "10" means the most severe anxiety. In the application, the patient was asked to mark the intensity of anxiety he felt on the ruler and the value was measured and recorded.
Anxiety (Visual Analog Scale-Anxiety)
Time frame: 10 minutes after surgery
Patients' anxiety will be evaluated (0-10 point). Grading is made with a 10 cm long horizontal or vertical ruler on the scale and "0" means no anxiety and "10" means the most severe anxiety. In the application, the patient was asked to mark the intensity of anxiety he felt on the ruler and the value was measured and recorded.
State-Trait Anxiety Inventory (STAI-II)
Time frame: Approximately 5-10 minutes before surgery
Trait anxiety will be assessed using the State-Trait Anxiety Inventory-II (STAI-II), which consists of 20 items and measures an individual's general tendency to experience anxiety. Higher scores indicate higher levels of trait anxiety.
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 14 Aug 2026.
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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 Music intervention and Stress ball in people with Cataract and Nursing Caries, run by Akdeniz 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 3 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 14 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?
Pain (Visual Analog Scale) (time frame: Immediately after surgery). The study lists 6 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 14 Aug 2026.