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Идёт набор NCT07452770

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

Без фазы С лечением Pain Fear Stress Ball Nursing

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Use of a stress ball during cataract surgery.
Кому может быть актуально
Состояния в реестре: Pain, Fear, Stress Ball, Nursing. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

  • Другое Use of a stress ball during cataract surgery
    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.

Первичные конечные точки

  • Patient Information Form [Срок оценки: Time point 1: preoperatively (immediately before surgery)]
  • Visual Analogue Scale (VAS) [Срок оценки: Time point 1: preoperatively (immediately before surgery) Time point 2: intraoperatively Time point 3: immediately postoperatively]
  • Surgical Fear Questionnaire (SFQ) [Срок оценки: Time point 1: preoperatively (immediately before surgery) Time point 2: intraoperatively Time point 3: immediately postoperatively]
  • Visual Comparison Scale for Satisfaction [Срок оценки: Time point 1: intraoperatively Time point 2: immediately postoperatively]

Критерии участия

Критерии включения

  • Individuals aged 18 years or older,
  • Without hearing or cognitive impairments,
  • Without any neurological conditions that would prevent squeezing a stress ball,
  • Without any physical limitations in the hands or arms that would prevent squeezing a stress ball,
  • Individuals undergoing cataract surgery for the first time will be included.

Критерии исключения

  • Under 18 years of age,
  • Change in anesthesia type during surgery (from topical anesthesia to general anesthesia)
  • Patients scheduled for cataract surgery under general anesthesia,
  • Patients with psychiatric disorders,
  • Patients diagnosed with uncontrolled hypertension,
  • Patients who used any analgesic or anxiolytic prior to surgery will not be included in the study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр
  • Bezmialem Vakif University — Istanbul

Публикации

  • 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. PMID 34872309
  • 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. PMID 26064671
  • 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. PMID 34177276
  • 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. PMID 38775768
  • 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. PMID 31509020
  • 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. PMID 40399154

Идентификаторы

NCT: NCT07452770 · BDEMİRCAN

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗