Evaluation of the Effectiveness of Stress Ball Practice During Cataract Surgery

NCT05847114 | Completed

• 1 other identifier: EGE-PhD-9319000443
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Cataract surgery is one of the most commonly performed and reliable surgeries among eye diseases. While cataract surgeries were performed under general or local anesthesia in previous years, they are now performed topically. Despite providing conscious sedation with agents such as benzodiazepines and opioids before and during surgery, patients experience pain, anxiety, and discomfort during the surgical procedure. One of the non-pharmacological methods used to relieve acute pain during surgical intervention is stress ball. It is also used to reduce pain and anxiety and increase patient comfort. The stress ball suppresses most of the nerves and muscles directly connected to the brain around the wrist and hand, stimulating nerve and muscle activity. This mechanism reduces the release of stress hormones, regulates blood pressure by providing relaxation and relief, and helps reduce anxiety and acute stress. When literature is examined, it is seen that stress ball application is effective on patients' pain, anxiety, and vital signs; however, no randomized controlled study has been found in which stress ball application was performed during cataract surgery. This study was planned to investigate the effect of stress ball application during cataract surgery on patients' anxiety, pain, and vital signs.

Conditions

Cataract; Anxiety; Pain

Keywords

cataract; stress ball; anxiety; pain; vital signs

Outcome Measures

Primary Outcomes (6)

• 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

• 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, during surgery and 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

• Vital signs

  In the measurement of vital signs of individuals, devices that measure digital blood pressure and pulse, O2 saturation will be used by applying the necessary hygiene rules at patient transitions.The respiratory rate will also be checked.

  15 minutes before surgery, during surgery and 10 minutes after surgery

Study Arms (2)

Stress Ball Group

EXPERIMENTAL

VAS-A, VAS, Spielberg Trait Anxiety Inventory was applied. Vital signs were evaluated before, during and after surgery. Stress balls were given to the patients in addition to the standard care protocol. Stress balls were used for 15 minutes during the operation, by placing the patient in both hands, counting from one to five, and tightening and loosening twice.

Other: Stres ball

Control Group

NO INTERVENTION

Patients in the control group will not undergo any intervention other than the standard care protocol.

Interventions

Stres ball OTHER

Stress ball compression for 15 minutes during surgery

Stress Ball Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: adult, older adult
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older,
• Absence of hearing and perception problems,
• Having no physical problems to squeeze a stress ball,
• First time cataract surgery.

You may not qualify if:

• Using any analgesic or anxiolytic before surgery,
• Conversion of topical anesthesia to general anesthesia during surgery,
• Having a psychiatric disorder
• Uncontrolled hypertension in the patient

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University

Izmir, Ege Üniversitesi Hemşirelik Fakültesi Bornova/İZMİR, 35100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cataract; Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Student

Study Record Dates

• First Submitted: April 4, 2023
• First Posted: May 6, 2023
• Study Start: September 26, 2022
• Primary Completion: April 24, 2023
• Study Completion: February 15, 2024
• Last Updated: October 10, 2024

Record last verified: 2024-10

Locations

TU (1)