Remote Assessment of Pain and Recovery Quality After Surgery Using a Digital Form: A Pilot Study
After surgery, doctors need to know how patients are doing, especially in the first hours after they leave the recovery room. This can be hard to track once patients go to a regular hospital room, and some symptoms - like pain or nausea - may go unnoticed.
This study tests whether an online form, sent to patients' phones, can help doctors check on pain and recovery in the first 12 and 24 hours after surgery. Patients (or a family member helping them) will receive a link by WhatsApp and answer a short set of questions about their pain, nausea, medications, and how they are recovering.
The main goal is to find out whether patients are willing and able to use this online form, and whether it is a helpful and practical way to follow up with them after surgery.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
Postoperative recovery is a dynamic process requiring continuous monitoring. After discharge from the post-anesthesia care unit (PACU), patients are typically assessed only through periodic in-person visits by the ward staff, which can create gaps in surveillance and lead to underreporting of pain, nausea, and other symptoms during the immediate postoperative period. Digital tools have been proposed as a way to narrow this gap by allowing patients to report symptoms directly and continuously, potentially enabling earlier identification of complications and more timely clinical response.
Despite promising results from international studies on postoperative digital monitoring, reviews have identified important gaps, including methodological heterogeneity, a lack of standardized and validated instruments, and limited integration with clinical teams. There is a particular scarcity of studies evaluating simple, accessible digital tools for the immediate postoperative period in Brazilian public hospitals.
This pilot study was designed to address that gap by testing a simplified, purpose-built digital form for remote postoperative follow-up. During the pre-anesthetic evaluation, patients (or an accompanying caregiver, when needed) are given a link, sent via WhatsApp, to a web-responsive online questionnaire designed for ease of use among postoperative patients. The form includes 18 questions covering pain at rest and during movement, nausea and vomiting, use of rescue analgesics and antiemetics, need for anesthesiology team intervention, functional recovery (ability to urinate and defecate), and overall satisfaction with the recovery process and with the questionnaire itself. Patients are asked to complete the form at two time points: 12 and 24 hours after PACU discharge.
The study's central hypothesis is that a simplified digital form is a feasible and well-accepted tool for remote postoperative monitoring, and that it can capture clinically meaningful data on pain, adverse effects, and perceived recovery. Findings from this pilot are intended to inform the future development of digital follow-up protocols - including potential integration with electronic medical records - for postoperative care in Brazilian public hospital settings, and to identify barriers to more equitable implementation of remote monitoring tools.
Тип исследования
Регистрация (Оцененный)
Контакты и местонахождение
Контакты исследования
- Имя: Fabrício T Mendonça, MD, TSA, MSc, PhD
- Номер телефона: 556133151588
- Электронная почта: correiodofabricio@gmail.com
Места учебы
-
-
Federal District
-
Brasília, Federal District, Бразилия, 70.335-902
- Hospital de Base do Distrito Federal (Instituto de Gestão Estratégica de Saúde do Distrito Federal - IGESDF)
-
Контакт:
- Nadja Glória C Graça, MD
- Номер телефона: 556133151588
- Электронная почта: seamp.hb@igesdf.org.br
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Метод выборки
Исследуемая популяция
Описание
Inclusion Criteria:
- Age ≥ 18 years
- Undergoing elective surgery with anticipated discharge from the post-anesthesia care unit (PACU) to the ward
- Access to a smartphone with internet connection (personally, or through an accompanying caregiver)
- Cognitive capacity to respond to the digital form, or availability of a caregiver to respond on the patient's behalf
- Signed Informed Consent Form
Exclusion Criteria:
- Anticipated postoperative admission to the intensive care unit (ICU)
- Inability to communicate, with no caregiver available to assist
- Refusal to participate or to use the digital tool
- No access to a mobile device/internet during the first 24 postoperative hours, with no logistical alternative available
- Clinical condition that, at the discretion of the assisting team, contraindicates participation
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
|
Postoperative Patients (Digital Form Cohort)
Adult patients (≥18 years) undergoing elective, non-ICU-bound surgery at a tertiary public hospital, who completed a digital web-based form to report pain, nausea/vomiting, medication use, functional recovery, and satisfaction at 12 and 24 hours after PACU discharge.
|
A responsive, 18-item online questionnaire, accessed via a WhatsApp link, used to remotely collect patient-reported data on pain, nausea/vomiting, medication use, functional recovery, and satisfaction at 12 and 24 hours after PACU discharge.
This is a data-collection tool and does not constitute a clinical/therapeutic intervention.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Adherence Rate to the Digital Follow-up Form
Временное ограничение: At 12 hours and at 24 hours after PACU discharge
|
Proportion of enrolled patients who fully completed the digital questionnaire, calculated separately at 12 and 24 hours after discharge from the post-anesthesia care unit (PACU).
|
At 12 hours and at 24 hours after PACU discharge
|
Соавторы и исследователи
Спонсор
Публикации и полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- CAAE 97978426.1.0000.8153
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .