Effects of Music and Stress Ball Application on Patients During Cataract Surgery

August 12, 2026 updated by: Seda Cansu Yeniğün, Akdeniz University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
240

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Any use of any analgesic or anxiolytic within 24 hours prior to surgery,
  • Transition from topical to general anesthesia during surgery,
  • Uncontrolled hypertension

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Stress ball
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.
Behavioral: Stress ball
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.
Experimental: Music intervention
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.
Behavioral: Music intervention
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.
No Intervention: Control
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
10 minutes after surgery
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.
Immediately after surgery
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.
approximately 5-10 minutes before surgery
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.
Immediately after surgery
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.
10 minutes after surgery
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.
Approximately 5-10 minutes before surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Akdeniz University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 20, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 13, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 15, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2490Akdeniz

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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