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

Not Applicable

Completed

• Conditions: Nursing Caries; Cataract

• Registration Number: NCT06555770
• Lead Sponsor: Akdeniz University

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.

Study Timeline

• Study First Submitted: 2024-08-13
• Study First Submitted QC: 2024-08-14
• Study First Posted: 2024-08-15
• Study Start: 2024-08-20
• Primary Completion: 2025-02-20
• Study Completion: 2025-03-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

• Being 18 years of age or older and undergoing PHACO surgery,
• Not having any hearing or perception problems,
• Not having any physical problems to squeeze a stress ball,
• 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,
• A psychiatric diagnosis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain (Visual Analog Scale)	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.
State-Trait Anxiety Inventory (STAI-II)	15 minutes before surgery	STAI-II is a well-researched clinical tool for evaluating the tendency towards anxiety. A cut-off point of 39-40 typically indicates clinically significant symptoms of a state of anxiety.
Anxiety (Visual Analog Scale-Anxiety)	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 pain he felt on the ruler and the value was measured and recorded.

Trial Locations

Locations (1)

Seda Cansu Yeniğün; 🇹🇷 Antalya, Kumluca, Turkey