Clinical trial NCT06555770: Effects of Music and Stress Ball Application on Patients During Cataract Surgery
Official title: Effects of Music and Stress Ball Application on Patients During Cataract Surgery Examining the Effect on Anxiety and Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Nursing Caries
Keywords: cataract
music intervention
stress ball
pain
anxiety
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2024-08-15
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain (Visual Analog Scale)
timeFrame: 15 minutes before surgery
measure: Pain (Visual Analog Scale)
timeFrame: During surgery
measure: Pain (Visual Analog Scale)
timeFrame: 10 minutes after surgery
measure: Anxiety (Visual Analog Scale-Anxiety)
timeFrame: 15 minutes before surgery
measure: Anxiety (Visual Analog Scale-Anxiety)
timeFrame: During surgery
measure: Anxiety (Visual Analog Scale-Anxiety)
timeFrame: 10 minutes after surgery
measure: State-Trait Anxiety Inventory (STAI-II)
timeFrame: 15 minutes before surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Seda Cansu Yeniğün
state: Kumluca
Study officials:
References: