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NCT Number: NCT06555770

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

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.

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Key information

Conditions

Cataract Anxiety Disorders Eye Diseases Lens Diseases Mental Disorders Neurologic Manifestations Nursing Caries Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seda Cansu Yeniğün

Antalya, Kumluca, 07350, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

müzik müdahalesi

Behavioral

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

Primary outcomes

  1. Pain (Visual Analog Scale)

    Time frame: 15 minutes before 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.

  2. Pain (Visual Analog Scale)

    Time frame: During 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.

  3. 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.

  4. Anxiety (Visual Analog Scale-Anxiety)

    Time frame: 15 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 pain he felt on the ruler and the value was measured and recorded.

  5. Anxiety (Visual Analog Scale-Anxiety)

    Time frame: During 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.

  6. 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 pain he felt on the ruler and the value was measured and recorded.

  7. State-Trait Anxiety Inventory (STAI-II)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Akdeniz University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 15, 2024
Registry last updated
Apr 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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