Viewing Study NCT06555770



Ignite Creation Date: 2024-10-26 @ 3:37 PM
Last Modification Date: 2024-10-26 @ 3:37 PM
Study NCT ID: NCT06555770
Status: NOT_YET_RECRUITING
Last Update Posted: None
First Post: 2024-08-13

Brief Title: Effects of Music and Stress Ball Application on Patients During Cataract Surgery
Sponsor: None
Organization: None

Study Overview

Official Title: Effects of Music and Stress Ball Application on Patients During Cataract Surgery Examining the Effect on Anxiety and Pain
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 eg 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None