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RecruitingNCT07452770

Stress Ball Use During Cataract Surgery: Effects on Pain, Fear and Satisfaction

The Effect of Stress Ball Use on Patients' Pain, Fear and Satisfication" During Cataract Surgery

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
60 (estimated)
Sponsor
Bezmialem Vakif University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The aim of this study is to determine the effect of stress ball use during cataract surgery on patients' pain, fear, and satisfaction levels.

Detailed description

Cataract is a condition in which the normally transparent lens of the eye or its capsule (the transparent membrane surrounding the lens) becomes cloudy or opaque, blocking the passage of light from the lens to the retina. Cataract disease, which increases with age, is a major cause of vision loss worldwide, especially in individuals aged 40 and older. Risk factors for cataracts include age, diabetes, smoking, and prolonged exposure to sunlight. Except for galactosemic cataracts, surgical intervention is the only effective treatment for cataracts. Cataract surgeries (phacoemulsification) were initially performed under general anesthesia or regional block, but today they are primarily performed using topical anesthesia. Patients who undergo topical anesthesia may experience fear and anxiety due to the unfamiliarity of the operating room environment and the fact that they are conscious. The main reasons for these feelings are the fear that the surgery will be painful, that it will fail, that vision will deteriorate, or that vision will be completely lost. Patients may also experience fear of moving their head or eyes during surgery, coughing, or being unable to cooperate with the surgeon. Studies indicate that patients who undergo surgery with a high level of fear also experience a higher level of pain after surgery. Pain can increase the difficulty of the surgery and result in complications by reducing patients' willingness to cooperate during surgery and their satisfaction with the surgery. Pain management during cataract surgery not only reduces pain and anxiety but also improves cooperation with the patient during the procedure. For this reason, it is emphasized that providing pain management during cataract surgery is particularly important. Today, non-pharmacological methods are used alongside pharmacological methods to control the pain, stress, and fear experienced by patients during the intraoperative process. Non-pharmacological methods are effective in reducing preoperative anxiety, fear of surgery, and anticipated pain. There are many non-pharmacological methods (stress balls, aromatherapy, music therapy, hand massage, virtual reality glasses, etc.) used to reduce patients' fears and ensure their comfort during surgery, and one of the important methods is the use of stress balls. Stress balls are an effective method for distracting patients because they are accessible and inexpensive. Stress balls are an effective distraction method for patients due to their accessibility and low cost. Evidence from previous studies suggests that using stress balls during medical procedures, such as cataract surgery and endoscopy, may help reduce patients' pain levels and increase their satisfaction. Knowledge about the effect of emotional factors such as pain perception and fear on the course of cataract surgery and their effects on the healing process of the eye is of great importance. When effective methods are applied to eliminate or reduce the effect of these factors, both the success of the surgery and the patient's satisfaction and quality of life can be improved. Therefore, the study was designed to determine the effect of using a stress ball, a non-pharmacological method, during cataract surgery on patients' pain, fear, and satisfaction levels. The sample size of the study was calculated using G\*Power 3.1.9.7 based on the data from a similar study in the literature14, using a t-test for the difference between two independent means, with 0.80 power, 95% confidence (1-α), an effect size of f=0.66, and a one-tailed hypothesis assumption.The minimum sample size was calculated to be 60. The following will be used to collect data: "Patient Information Form," "Visual Analogue Scale (VAS)," "Visual Comparison Scale for Satisfaction," and "Surgical Fear Questionnaire". Data will be analyzed using the IBM SPSS Statistics 29.0 software package, and statistical significance will be assessed at the p\<0.05 level.

Conditions

Interventions

TypeNameDescription
OTHERUse of a stress ball during cataract surgeryTo examine the effect of using a stress ball, a non-pharmacological method, during scheduled cataract surgery on patients' pain, surgical fear, and satisfaction levels.

Timeline

Start date
2025-09-01
Primary completion
2026-04-15
Completion
2026-05-15
First posted
2026-03-05
Last updated
2026-03-06

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07452770. Inclusion in this directory is not an endorsement.