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The aim of this study is to determine the effect of stress ball use during cataract surgery on patients' pain, fear, and satisfaction levels.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group: the group using a stress ball | Experimental | Patients who used a stress ball during cataract surgery |
|
| Control group: Patients who did not use a stress ball | No Intervention | Patients who received standard care without using a stress ball during cataract surgery |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Use of a stress ball during cataract surgery | Other | To examine the effect of using a stress ball, a non-pharmacological method, during scheduled cataract surgery on patients' pain, surgical fear, and satisfaction levels. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Information Form | Prepared by researchers based on a review of similar studies on the subject in the literature. The form contains six (6) questions regarding the socio-demographic characteristics of patients who have undergone cataract surgery, including age, marital status, educational status, employment status, and economic status; and six (6) questions regarding the presence of chronic diseases, regular medication use, smoking/alcohol consumption, previous hospitalizations, and previous cataract surgeries, for a total of 12 questions. | Time point 1: preoperatively (immediately before surgery) |
| Visual Analogue Scale (VAS) | First defined in 1921 and used to assess patients' subjective pain levels, the VAS is a form consisting of a horizontal line 10 cm long. The leftmost part of this measurement tool indicates "no pain," while the rightmost part indicates "unbearable pain." A high score on the scale indicates severe pain, while a low score indicates mild pain. The scale is scored as follows: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, and 7-10 = severe pain. | Time point 1: preoperatively (immediately before surgery) Time point 2: intraoperatively Time point 3: immediately postoperatively |
| Surgical Fear Questionnaire (SFQ) | Developed by Theunissen et al. (2014), this scale consists of 8 items and aims to assess the long- and short-term levels of anxiety experienced by patients scheduled for elective surgery. The Turkish validity and reliability study was conducted by BaÄźdigen and Karaman Ă–zlĂĽ in 2016. The scale consists of 11 Likert-type items, a total of eight items, and two subscales: fear of the short-term and long-term outcomes of surgery. Items 1 to 4 inquire about the short-term outcomes of surgery, while items 5 to 8 inquire about the long-term outcomes.The Cronbach's alpha coefficient for the CKĂ– total score was found to be 0.934, for the CKĂ–-Short-term fears subscale 0.960, and for the CKĂ–-Long-term fears subscale 0.907. As the scale score increases, the patients' level of surgical fear increases. | Time point 1: preoperatively (immediately before surgery) Time point 2: intraoperatively Time point 3: immediately postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Burcu DEMİRCAN BDEMİRCAN, PhD | Contact | +905072325511 | bdemircan@bezmialem.edu.tr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bezmialem Vakif University | Recruiting | Istanbul | Istanbul | 34065 | Turkey (TĂĽrkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34872309 | Result | Zeng K, Li Q, Xi W, Qiao Y. Measures to improve the comfort of cataract surgery patients: a systematic review and meta-analysis. Ann Palliat Med. 2021 Nov;10(11):11849-11858. doi: 10.21037/apm-21-2945. | |
| 26064671 | Result | Jiang L, Zhang K, He W, Zhu X, Zhou P, Lu Y. Perceived Pain during Cataract Surgery with Topical Anesthesia: A Comparison between First-Eye and Second-Eye Surgery. J Ophthalmol. 2015;2015:383456. doi: 10.1155/2015/383456. Epub 2015 May 4. |
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Because the data collection process is ongoing and has not yet been completed.
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| ID | Term |
|---|---|
| D010146 | Pain |
| D000377 | Agnosia |
| D010549 | Personal Satisfaction |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
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Randomized Controlled Trial
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| Visual Comparison Scale for Satisfaction | In this scale, satisfaction levels are determined by scoring between 0 and 10. A score of "0" represents the lowest level of satisfaction, while a score of "10" represents the highest level of satisfaction. Patients are asked to indicate the level of their pain on a scale from 0 to 10, with the numerical value representing the patient's satisfaction level. | Time point 1: intraoperatively Time point 2: immediately postoperatively |
| 34177276 | Result | Obuchowska I, Konopinska J. Fear and Anxiety Associated with Cataract Surgery Under Local Anesthesia in Adults: A Systematic Review. Psychol Res Behav Manag. 2021 Jun 18;14:781-793. doi: 10.2147/PRBM.S314214. eCollection 2021. |
| 38775768 | Result | Dastan N, Sezer Efe Y, Erkilic K. The Effect of Hand Massage Applied Before Cataract Surgery on Anxiety, Surgical Fear, Pain and Physiological Parameters. J Perianesth Nurs. 2024 Oct;39(5):831-838. doi: 10.1016/j.jopan.2023.12.018. Epub 2024 May 22. |
| 31509020 | Result | Socea SD, Abualhasan H, Magen O, Zayit-Soudry S, Blumenthal EZ, Duvdevan N, Mimouni M. Preoperative Anxiety Levels and Pain during Cataract Surgery. Curr Eye Res. 2020 Apr;45(4):471-476. doi: 10.1080/02713683.2019.1666996. Epub 2019 Sep 18. |
| 40399154 | Result | Yenigun SC, Demir Korkmaz F. The Effects of Stress Ball Practice on Patient Anxiety, Pain and Vital Signs During Cataract Surgery: A Randomized Controlled Trial. Pain Manag Nurs. 2025 Oct;26(5):592-599. doi: 10.1016/j.pmn.2025.04.009. Epub 2025 May 20. |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D001519 | Behavior |