- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07794267
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Fabrício T Mendonça, MD, TSA, MSc, PhD
- Numéro de téléphone: 556133151588
- E-mail: correiodofabricio@gmail.com
Lieux d'étude
-
-
Federal District
-
Brasília, Federal District, Brésil, 70.335-902
- Hospital de Base do Distrito Federal (Instituto de Gestão Estratégica de Saúde do Distrito Federal - IGESDF)
-
Contact:
- Nadja Glória C Graça, MD
- Numéro de téléphone: 556133151588
- E-mail: seamp.hb@igesdf.org.br
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Adherence Rate to the Digital Follow-up Form
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CAAE 97978426.1.0000.8153
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .