The Effect of a Stress Ball Applied Before Retrograde Intrarenal Surgery on Anxiety, Surgical Fear, and Hemodynamic Parameters
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: stress ball.
- Кому может быть актуально
- Состояния в реестре: Anxiety, Fear. 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 →
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Официальное название
The Effect of a Stress Ball Applied Before Retrograde Intrarenal Surgery on Anxiety, Surgical Fear, and Hemodynamic Parameters: A Randomized Controlled Trial
Обзор
This study was designed as a randomized controlled trial to determine the effect of a stress ball applied before retrograde intrarenal surgery on patients' anxiety levels, surgical fear, and hemodynamic parameters.
Подробное описание
Retrograde intrarenal surgery (RIRS), a minimally invasive surgical procedure, is widely used in the treatment of kidney stones. Although RIRS is considered a minimally invasive intervention, patients may still experience significant levels of anxiety and surgical fear in the preoperative period due to the diagnostic and treatment process. These preoperative responses may lead to changes in hemodynamic parameters such as heart rate, respiratory rate, and blood pressure through activation of the sympathetic nervous system . Increased anxiety levels may negatively affect patients' adaptation to the surgical process and may also increase the risk of perioperative complications . In addition, preoperative surgical fear may adversely affect anxiety levels in the postoperative period . Surgical fear and anxiety are among the important factors that increase patients' perception of pain and negatively affect the perioperative process. Anxiety that cannot be controlled in the preoperative period may lead to negative outcomes in terms of postoperative pain, analgesic requirements, and the recovery process. Therefore, managing anxiety and surgical fear before surgery is crucial for improving patient safety and the quality of care. Non-pharmacological methods are effective in managing preoperative anxiety. However, pharmacological approaches may have limitations such as sedation, risk of side effects, and additional costs. In recent years, to reduce these limitations, distraction-based non-pharmacological methods have been increasingly used in urological and other surgical procedures. These methods include interventions such as music therapy (in urological surgeries) and stress ball use (in procedures such as cataract surgery and angiography).The use of a stress ball is a method that enables rhythmic activation of hand muscles. As a non-pharmacological intervention, it is a simple, safe, practical, and up-to-date approach that helps divert the individual's attention away from anxiety-provoking stimuli. The literature reports that the use of stress balls before and during various invasive and surgical procedures reduces anxiety, pain, and surgical fear, and helps maintain stability in hemodynamic parameters such as heart rate and blood pressure. Recent randomized controlled trials conducted in procedures such as cholecystectomy, angiography, cataract surgery, and day-case surgeries have demonstrated that stress ball application has positive effects on patient outcomes (pain, anxiety, or comfort). In the study by Alptekin et al., it was found that the stress ball applied before cystectomy significantly reduced anxiety levels and surgical fear scores compared to the control group (p\<0.05). Similarly, in patients undergoing cataract surgery, stress ball use was reported to reduce pain and anxiety and significantly decrease pulse and respiratory rate.Although studies focusing specifically on the preoperative period of RIRS are limited, it is known that preoperative anxiety and surgical fear are common in urological surgeries and may lead to changes in hemodynamic variables. In this context, evaluating the effectiveness of an easily applicable method such as a stress ball in the preoperative period of RIRS is expected to fill an important gap in the literature. To the best of our knowledge, no study has been found examining the effects of stress ball application before RIRS on anxiety, surgical fear, and hemodynamic variables.
Вмешательства
- Другое stress ball
After completing the data collection form, participants in the intervention group will undergo the stress ball application conducted by T.Ç.Y. and N.B. In addition to the clinic's routine treatment and care procedures, patients in the intervention group will be briefly instructed and shown how to use the stress ball approximately 45 minutes before leaving the clinic. The stress ball application will last for approximately 15 minutes. A round, medium-firm, high-quality silicone ball with an appro
Первичные конечные точки
- Visual Analog Scale for Anxiety (VAS-A) [Срок оценки: Before the stress ball application, immediately after, and 15 minutes after the intervention]
Вторичные конечные точки (6)
- Surgical Fear Scale [Срок оценки: Before the stress ball application, immediately after, and 15 minutes after the intervention]
- Systolic blood pressure changes after stress ball [Срок оценки: Before the stress ball application, immediately after, and 15 minutes after the intervention]
- Diastolic blood pressure changes after stress ball [Срок оценки: Before the stress ball application, immediately after, and 15 minutes after the intervention]
- Heart rate changes after stress ball [Срок оценки: Before the stress ball application, immediately after, and 15 minutes after the intervention]
- Respiratory rate changes after stress ball [Срок оценки: Before the stress ball application, immediately after, and 15 minutes after the intervention]
- Oxygen saturation values changes after stress ball [Срок оценки: Before the stress ball application, immediately after, and 15 minutes after the intervention]
Критерии участия
Критерии включения
Patients to be included in the study are those who:
- Are scheduled to undergo Retrograde Intrarenal Surgery (RIRS),
- Are 18 years of age or older,
- Are conscious and cooperative,
- Speak and understand Turkish,
- Have stable general condition and hemodynamic parameters,
- Are scheduled for an elective surgical procedure,
- Have no psychiatric diagnosis,
- Are not using psychiatric and/or local neuromuscular blocking medications,
- Provide informed consent to participate in the study (have signed the Informed Consent Form).
Критерии исключения
Patients who will not be included in the study are those who:
- Are under 18 years of age,
- Are not conscious or cooperative,
- Do not speak or understand Turkish,
- Have unstable general condition or hemodynamic parameters,
- Are undergoing emergency surgical procedures,
- Have an existing psychiatric diagnosis,
- Are using psychiatric and/or local neuromuscular blocking medications,
- Do not consent to participate in the study (have not signed the Informed Consent Form).
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
- Двойное слепое
- Основная цель
- Поддерживающая терапия
Центры проведения
Turkey (Türkiye) · 1 центр
- Turkey, Mersin University, — Yenişehir
Идентификаторы
NCT: NCT07507656 · Mersin_Unıve · Tuğba ÇAM YANIK