Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07396532
Brief Summary:
The goal of this pilot clinical trial is to learn if personalized audio-recorded reorientation messages can be successfully implemented in general hospital wards for elderly patients after hip fracture surgery. It will also explore whether this intervention might help prevent confusion (delirium) after surgery. The main questions it aims to answer are:
* Can the intervention be successfully delivered by nursing staff in a busy orthopedic ward?
* How many eligible patients can be recruited and retained in the study?
* Do patients tolerate listening to the personalized audio messages without problems?
* Does listening to personalized audio messages show any early signs of reducing confusion after surgery?
Researchers will compare patients who receive personalized audio messages to those who receive usual care to see if the intervention is feasible to implement and whether it shows promise for preventing delirium.
Participants will:
* Listen to 2-minute personalized audio-recorded reorientation messages played through an iPad and headphones three times daily for the first 3 days after surgery
* Have their orientation and mental status checked daily for three times by nursing staff
* Continue with all their regular medical care and treatments
* Be monitored until discharge from the study wards.
Detailed Description:
Background and Rationale:
Hip fracture surgery is common among elderly patients, but recovery can be complicated by post-operative delirium (confusion), which affects up to 50% of patients and can lead to longer hospital stays, increased complications, and delayed rehabilitation. Non-pharmacological interventions, particularly reorientation strategies, have shown promise in preventing delirium, but implementation in busy hospital wards remains challenging.
Study Design and Innovation:
This pilot randomized controlled trial tests an innovative approach using personalized audio-recorded reorientation messages delivered via 'Shortcut' Application on the iPad technology. The messages are available in multiple languages (English, Mandarin, Malay, Tamil) to accommodate the diverse patient population, but the content is standardized across all participants. This technology-supported approach enables nurses to provide systematic reorientation interventions as part of their routine care.
Intervention Details:
The audio messages are approximately 2 minutes long and include: reorientation information (patient's location, real-time update of date and time, reason for admission), explanation of their recovery process, encouragement for therapy participation, pain management guidance, and reassuring messages on who are taking care of them in the hospital. Messages are played through noise-canceling headphones to ensure clarity and minimize ward noise interference.
Implementation Approach:
Nursing staff receive brief training on the iPad system and the workflow process. The intervention is designed to be sustainable within existing workflow patterns without adding significant burden to clinical staff. Visual reminders of workflow process were also readily available in nursing stations to remind the nurses. Study team also do their rounds to ensure availability of equipment and to clarify doubts from nursing staff.
Target Population:
Elderly patients (≥60 years) admitted to orthopedic wards following hip fracture surgery who are at risk for developing post-operative delirium based on established risk factors.
Feasibility Focus:
As a pilot study, this research prioritizes understanding implementation challenges, staff acceptance, patient tolerance, and recruitment feasibility to inform the design of a future definitive trial examining delirium prevention effectiveness.
Study:
NCT07396532
Study Brief:
Protocol Section:
NCT07396532