Меню
Набор скоро начнётся NCT07203989

The Effect of Video Calls With Family Members During Operating Room Waiting on Stress, Anxiety, and Surgical Fear in Patients Undergoing Transurethral Resection of Bladder Tumor

Без фазы С лечением Bladder Tumor (TURBT) Bladder (Urothelial, Transitional Cell) Cancer

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: family-supported care.
Кому может быть актуально
Состояния в реестре: Bladder Tumor (TURBT), Bladder (Urothelial, Transitional Cell) Cancer. Базовые параметры: 18 лет — 100 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 Video Calls With Family Members During Operating Room Waiting on Stress, Anxiety, and Surgical Fear in Patients Undergoing Transurethral Resection of Bladder Tumor: A Multicenter Randomized Controlled Trial

Обзор

This study aims to investigate the effect of video calls with family members during the preoperative waiting period in the operating room on stress, anxiety, and surgical fear in patients undergoing transurethral resection of bladder tumor (TURBT). Bladder cancer is a common urological malignancy, and psychological problems are frequently observed in the preoperative period. The absence of family support in the operating room may increase anxiety and fear, triggering physiological stress responses and raising the risk of complications. This multicenter randomized controlled trial will be conducted between September 2025 and March 2027 at Bitlis State Hospital and Tatvan State Hospital. The study sample will include 128 eligible patients, randomly assigned to intervention and control groups. Patients in the intervention group will have a video call with a designated family member in the operating room, while control group patients will receive routine care. Data will be collected using the Descriptive Information Form, the Surgical Fear Questionnaire, and the Visual Analogue Scale; stress levels will be assessed through serum cortisol and glucose values. Measurements will be taken at three time points: preoperatively (T0), immediately before anesthesia (T1), and on the first postoperative day (T2). The study is expected to demonstrate that maintaining family support through video calls in the preoperative period reduces anxiety, fear, and stress, thereby improving surgical outcomes and contributing to the development of family-centered care practices.

Подробное описание

This study investigates the effect of family-supported video calls on patients with bladder tumor scheduled for transurethral resection (TURBT) during the preoperative waiting period in the operating room. Preoperative anxiety, surgical fear, and stress are common among surgical patients and may negatively influence physiological responses and postoperative outcomes. Allowing real-time communication with a family member through a secure digital platform may provide psychological support, reduce anxiety and fear, and mitigate stress-related physiological changes.

The study is designed as a multicenter randomized controlled trial conducted at Bitlis State Hospital and Tatvan State Hospital between September 2025 and March 2027. Eligible patients will be randomly assigned to either the intervention group, who will have a structured video call with a designated family member before anesthesia induction, or the control group, who will receive standard preoperative care without family contact in the operating room. Outcomes will include anxiety, surgical fear, and stress levels, measured using validated scales and physiological parameters. Findings from this study are expected to contribute to the development of family-centered care strategies aimed at improving perioperative psychological well-being and surgical outcomes.

Вмешательства

  • Поведенческое family-supported care
    Family video calling in the operating room

Первичные конечные точки

  • Change in Anxiety Level (Visual Analogue Scale) [Срок оценки: Anxiety levels will be measured at three different time points: T0: On the morning of the surgery, at 08:00 in the ward T1: In the operating room, immediately before anesthesia induction T2: The morning after the surgery, at 08:00]
  • stress [Срок оценки: Blood samples will be collected from patients at three different times. • T0: On the morning of surgery, in the ward at 8:00 a.m. • T1: In the operating room, just before anesthesia induction • T2: The day after surgery, at 8:00 a.m.]
  • Surgical Fear Level [Срок оценки: Patients' surgical fear levels will be measured at two different times. • T0: On the morning of surgery, in the ward at 8:00 a.m. • T1: In the operating room, just before anesthesia induction]

Критерии участия

Критерии включения

  • Age 18 years or older
  • Able to read and write in Turkish
  • Scheduled for transurethral resection of bladder tumor (TURBT)
  • Has a family member, friend, or relative able to participate in video calls
  • The accompanying family member or relative has a device suitable for video calls (smartphone, tablet, etc.)
  • Has waited at least 20 minutes in the operating room before surgery
  • No hearing, speech, or language-related communication barriers
  • No psychological disorders that could affect fear or anxiety
  • Not using medications that could alter fear or anxiety levels
  • Scheduled for surgery between 08:00 and 12:00
  • Willing to voluntarily participate in the study

Критерии исключения

  • Surgery is canceled after the patient has been enrolled in the study
  • Patient chooses to withdraw from the study after enrollment
  • Individuals with any diagnosed chronic disease
  • Experiencing connection problems during the video call
  • Patients who receive premedication during the waiting period to relieve anxiety

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
Простое слепое
Основная цель
Другое

Центры проведения

Turkey (Türkiye) · 2 центра
  • Tatvan State Hospital, Bitlis, Turkey — Bitlis
  • Bitlis State Hospital, Bitlis, Turkey — Bitlis

Идентификаторы

NCT: NCT07203989 · HKU-2025-TURBT-FV-RCT01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗