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

Effects of Music and Stress Ball Application on Patients During Cataract Surgery Examining the Effect on Anxiety and Pain

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06555770
Enrollment
240
Registered
2024-08-15
Start date
2024-08-20
Completion date
2025-03-01
Last updated
2026-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract, Nursing Caries

Keywords

cataract, music intervention, stress ball, pain, anxiety

Brief 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. 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.

Interventions

BEHAVIORALMusic 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.

BEHAVIORALStress 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.

Sponsors

Akdeniz University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Pain (Visual Analog Scale)Immediately after surgeryGrading 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)approximately 5-10 minutes before surgeryPatients' 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)Approximately 5-10 minutes before surgeryTrait 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 15, 2026