Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2025-12-29 @ 7:26 PM
Study NCT ID:
NCT07108192
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-06
First Post:
2025-07-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Hand Holding and Stress Ball Intervention on Pain and Anxiety
Sponsor:
Sakarya University
Organization:
Study Overview
Official Title:
The Effect of Hand Holding and Stress Ball Intervention on Pain and Anxiety During Cataract Surgery: A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Cataract surgery is currently primarily performed with topical anesthesia. Although topical anesthesia provides many benefits for patients, they may experience pain, anxiety and discomfort during surgery. It has been reported that increased pain and anxiety during surgery may decrease patient cooperation and satisfaction, making surgery more difficult. In this context, in addition to medical interventions, non-pharmacologic methods are recommended to manage pain and anxiety during surgery. Non-pharmacological methods are reported to be simple, effective and cost-effective. In this context, studies have shown that stress ball application and hand holding are effective strategies for the control of pain and anxiety in patients.
According to this information, the aim of this study was to evaluate the effect of stress ball application and hand holding method used during cataract surgery on patients' pain and anxiety.
Another aim of the study was to determine the effects of stress ball application and hand holding method on patients' satisfaction levels and vital signs.
According to this information, the aim of this study was to evaluate the effect of stress ball application and hand holding method used during cataract surgery on patients' pain and anxiety.
Another aim of the study was to determine the effects of stress ball application and hand holding method on patients' satisfaction levels and vital signs.
Detailed Description:
Cataract is the main cause of visual impairment and blindness globally and surgery remains the only effective treatment for cataract. Today, it is a common procedure for routine cataract surgery under topical anesthesia. Topical anesthesia is most commonly used because it eliminates potential complications such as optic nerve damage, retrobulbar hemorrhage and ocular muscle injury. However, topical anesthesia does not eliminate pain sensitivity of the iris, zonule and ciliary body during cataract surgery. Moreover, patients may experience discomfort due to manipulation of intraocular structures during surgery. However, patients are awake during surgery to follow the surgeon's instructions, which can lead to anxiety and adverse consequences in physiologic parameters such as tachycardia and hypertension. Patients may move during surgery due to anxiety and pain, and may lose visual function due to bleeding or post-surgical complications such as glaucoma. Therefore, assessing and controlling pain and anxiety during surgery is important for patient comfort and surgical prognosis. Moreover, the management of pain and anxiety during surgery not only reduces patients' anxiety but also increases patient cooperation during surgery. In this context, pharmacological as well as non-pharmacological methods are widely used in the management of pain and anxiety. Although the effects of hand holding and stress ball application on patients' pain, anxiety, satisfaction levels and vital signs in various contexts have been reported, their effects, especially during cataract surgery, have not been sufficiently investigated. Therefore, this study aims to contribute to the existing literature by examining the effects of hand holding and stress ball application on patients' pain, anxiety, satisfaction levels and vital signs during cataract and to provide evidence for the importance of the use of nonpharmacologic methods.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: