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

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: Completed
• Conditions: Cataract; Nursing Caries
• Intervention / Treatment: Behavioral: müzik müdahalesi

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: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kumluca
    • Antalya, Kumluca, Turkey, 07350
      • Seda Cansu Yeniğün

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stres topu grubu; 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 stress balls will be given to both hands of the patient, counting to five and pressing twice. The patient will be shown to use the stress balls for 15 minutes during the surgery. The patient will be told to use the stress balls for 15 minutes during the surgery. After 15 minutes, the researcher will inform the patient and make sure the patient drops the balls.	Behavioral: müzik müdahalesi; One group of patients will be listening to music for 15 minutes during the surgery, while the other group will be applied a stress ball.; Other Names: stres topu
Experimental: Müzik grubu; Pain levels will be tested with VAS 10 minutes before the surgery, and anxiety levels with the VAS-A and Spielberg Continuous Anxiety Scale. According to the randomization, the patient in the music intervention group will first be asked by the researcher to select his favorite music from the playlist. The playlist will be created using the Spotify app. The playlist will include a total of 50 songs from each group (pop, Turkish art music, local Turkish and religious music), including ten songs. Options will be shown to the patient on the phone (Apple/MU783TU/A) and the music he wants will be added to the playlist. The patient will be told that the selected music will be listened to for 15 minutes during cataract surgery.	Behavioral: müzik müdahalesi; One group of patients will be listening to music for 15 minutes during the surgery, while the other group will be applied a stress ball.; Other Names: stres topu
No Intervention: Kontrol grubu; 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

Outcome Measure	Measure Description	Time Frame
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.	15 minutes before 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.	During 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.	10 minutes after surgery
State-Trait Anxiety Inventory (STAI-II)	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.	15 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 pain he felt on the ruler and the value was measured and recorded.	15 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 pain he felt on the ruler and the value was measured and recorded.	During 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 pain he felt on the ruler and the value was measured and recorded.	10 minutes after surgery

Collaborators and Investigators

• Sponsor: Akdeniz University

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2024
• Primary Completion (Actual): February 20, 2025
• Study Completion (Actual): March 1, 2025

Study Registration Dates

• First Submitted: August 13, 2024
• First Submitted That Met QC Criteria: August 14, 2024
• First Posted (Actual): August 15, 2024

Study Record Updates

• Last Update Posted (Actual): April 25, 2025
• Last Update Submitted That Met QC Criteria: April 23, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: pain; anxiety; cataract; music intervention; stress ball
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID 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