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Набор скоро начнётся NCT07512024

Effects of Postoperative Video-assisted Early Mobilization on Recovery Outcomes

Без фазы С лечением Cholelithiasis

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: Video-Assisted Early Mobilization Training.
Кому может быть актуально
Состояния в реестре: Cholelithiasis. Базовые параметры: 18 лет — 65 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
Список центров уточняется — проверьте первичный протокол.
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-assisted Early Mobilization Training on Patient Outcomes in Individuals Undergoing Laparoscopic Cholecystectomy: a Randomized Controlled Trial

Обзор

This randomized controlled trial aims to evaluate the effects of video-assisted early mobilization education on postoperative recovery in patients undergoing laparoscopic cholecystectomy. As part of the intervention, structured and professionally produced educational videos will be used to explain the physiological benefits of early mobilization in the preoperative period and to demonstrate step-by-step mobilization techniques in the postoperative period. Patients in the intervention group will receive video-assisted mobilization education in addition to standard postoperative care, while patients in the control group will receive standard care alone. Physical activity levels will be objectively monitored using wearable activity tracking devices during the first 24 hours after surgery. The study will assess the effects of video-assisted early mobilization education on postoperative physiological stress response, pain, nausea and vomiting, blood glucose levels, mobilization performance, gastrointestinal recovery, length of hospital stay, and patient satisfaction. In addition, postoperative complications, emergency department visits, and hospital readmissions within 30-days after surgery will be evaluated as exploratory outcomes.

Подробное описание

Laparoscopic cholecystectomy is among the most frequently performed surgical procedures worldwide and is associated with shorter recovery times and lower postoperative complication rates compared with open surgery. However, despite the advantages of minimally invasive techniques, postoperative physiological stress responses-characterized by elevations in cortisol and glucose levels-together with pain, nausea, delayed mobilization, and prolonged gastrointestinal recovery remain significant challenges to achieving optimal patient outcomes. Early mobilization is a key component of Enhanced Recovery After Surgery (ERAS) protocols and has been shown to reduce postoperative complications, accelerate functional recovery, and shorten hospital length of stay. Nevertheless, limited patient awareness and insufficient education continue to represent major barriers to effective adherence to mobilization recommendations.

This randomized controlled trial investigates whether video-assisted early mobilization education, combined with objective monitoring using wearable activity tracking systems, can improve postoperative outcomes in patients undergoing laparoscopic cholecystectomy. The intervention consists of two professionally produced educational videos developed in a university television studio: Part 1 of the video; a preoperative theoretical module that explains the physiological benefits of early mobilization using clear language supported by animations, and Part 2 of the video; a postoperative practical module recorded in an actual patient room, demonstrating safe and stepwise mobilization techniques based on evidence-based ERAS practices. The video content has been culturally adapted and will be pilot-tested to ensure comprehensibility across different levels of health literacy.

Participants will be randomly assigned in a 1:1 ratio to either the intervention group or the control group using a computer-generated block randomization method. Both groups will receive standard postoperative care; however, only the intervention group will receive the video-based mobilization education. To maintain objectivity, patients in both groups will wear passive pedometer devices during the first 24 hours after surgery. These devices will record step count, time to first mobilization, and total ambulation duration, while motivational feedback features will be disabled to ensure that any observed effects can be attributed solely to the video intervention.

Physiological stress responses will be assessed using salivary cortisol and capillary glucose measurements collected at four standardized time points: preoperative baseline (T0), postoperative hour 3 (T1), hour 6 (T2), and hour 24 (T3). These time points were selected based on the circadian rhythm of cortisol secretion and the temporal dynamics of the surgical stress response. Postoperative symptoms, including pain, nausea, and vomiting, will be evaluated using validated Visual Analogue Scales. Functional outcomes will include step count, walking duration, and time to first mobilization. Clinical outcomes, such as length of hospital stay, time to first flatus, oral intake, and defecation, as well as stability of vital signs (heart rate, blood pressure, respiratory rate, body temperature, and peripheral oxygen saturation \[SpO₂\]), will also be monitored. In addition, postoperative follow-up at 30 days will be conducted to assess emergency department visits, hospital readmissions, and complications.

This study aims to generate robust evidence regarding the effectiveness of digital, video-based patient education integrated with wearable technology in optimizing postoperative recovery. It is anticipated that video-assisted early mobilization education may reduce physiological stress markers, enhance mobilization performance, improve adherence to ERAS protocols, shorten recovery timelines, and increase patient satisfaction. Given that the intervention is easily scalable and adaptable to different surgical populations, the findings of this trial may contribute to clinical practice improvement, inform national health policy development, and support cost-effective, technology-assisted perioperative care strategies.

Вмешательства

  • Поведенческое Video-Assisted Early Mobilization Training
    A behavioral intervention consisting of a structured, professionally produced video-based early mobilization training program delivered preoperatively and postoperatively. The intervention aims to enhance patient engagement, improve mobilization performance, and reduce postoperative physiological stress responses.

Первичные конечные точки

  • Change in Salivary Cortisol Levels Over Time [Срок оценки: Preoperative baseline (time point 0), and at 3 hours (time point 1), 6 hours (time point 2), and 24 hours (time point 3) after surgery.]
Вторичные конечные точки (11)
  • Change in Blood Glucose Levels Over Time [Срок оценки: Preoperative baseline (time point 0), and at 3 hours (time point 1), 6 hours (time point 2), and 24 hours (time point 3) after surgery.]
  • Postoperative Pain Intensity [Срок оценки: Preoperative baseline (time point 0), and at 3 hours (time point 1), 6 hours (time point 2), and 24 hours (time point 3) after surgery.]
  • Postoperative Nausea and Vomiting (PONV) [Срок оценки: From the completion of surgery through the first 24 hours postoperative.]
  • Step count [Срок оценки: From the completion of surgery through the first 24 hours postoperative.]
  • Ambulation duration [Срок оценки: From the completion of surgery through the first 24 hours postoperative.]
  • Time to first mobilization [Срок оценки: From the completion of surgery until the first mobilization event (within 24 hours postoperative).]
  • Time to first oral intake [Срок оценки: From the completion of surgery until the first oral intake occurs (up to study completion, an average of 3 days).]
  • Time to first flatus [Срок оценки: From the completion of surgery until the first flatus occurs (up to study completion, an average of 3 days).]
  • Time to first defecation [Срок оценки: From the completion of surgery until the first defecation occurs (up to study completion, an average of 3 days).]
  • Length of Hospital Stay [Срок оценки: From the completion of surgery until hospital discharge, up to 72 hours.]
  • Number of participants with stable vital signs [Срок оценки: Baseline (preoperative), and at 3 hours (time point 1), 6 hours (time point 2), and 24 hours (time point 3) after surgery.]

Критерии участия

Критерии включения

  • Adults aged 18 to 65 years.
  • Scheduled for elective laparoscopic cholecystectomy.
  • Classified as ASA I or ASA II according to the American Society of Anesthesiologists Physical Status Classification.
  • Ability to read and understand Turkish.
  • Adequate cognitive capacity to understand video education and operate the wearable activity tracker.
  • Willingness to participate and signing the informed consent form

Критерии исключения

  • Chronic pain syndrome or severe chronic orthopedic/rheumatologic pain conditions.
  • Pre-existing mobility limitations.
  • Endocrine or metabolic diseases affecting cortisol or glucose (e.g., diabetes, thyroid disorders, Addison's disease, Cushing's syndrome).
  • Use of medications affecting the HPA axis (e.g., systemic corticosteroids, chronic opioids, high-dose benzodiazepines).
  • Diagnosed severe psychiatric or cognitive disorders (e.g., dementia, major depression).
  • Skin allergies or medical device contraindications preventing use of the activity tracker.
  • Conversion to open surgery or major intraoperative complications.

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
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07512024 · 228425

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗