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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
0mo left

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Sep 2025Jul 2026

Study Start

First participant enrolled

September 29, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 3, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 9, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

7 months

First QC Date

December 3, 2025

Last Update Submit

February 2, 2026

Conditions

Keywords

deliriumnurse-ledreality reorientationAI

Outcome Measures

Primary Outcomes (4)

  • Protocol Adherence Rate

    Percentage of planned audio-recorded reorientation sessions successfully delivered by the nurses across the first 3-day intervention period. Target adherence rate ≥95% to demonstrate intervention feasibility.

    Postoperative day 1 to postoperative day 3

  • Recruitment Feasibility

    Recruitment feasibility measured by screening-to-enrollment rate, calculated as: (1) percentage of screened patients meeting eligibility criteria, and (2) percentage of eligible patients providing informed consent. These rates will be tracked throughout the study period to assess the feasibility of recruiting the target population for a future definitive trial. Target enrollment rate of ≥80% of eligible patients will indicate feasibility.

    From enrollment to end of study participation (up to 2 weeks)

  • Study Retention Rate

    Percentage of enrolled participants who completed the study protocol without withdrawal, calculated as number completing study divided by total enrolled. Target retention rate ≥90% to demonstrate intervention feasibility.

    From enrollment to end of study participation (up to 2 weeks)

  • Intervention Tolerance Rate

    Completion of each audio-recorded reorientation session without early discontinuation or adverse reactions, assessed during each of the 9 planned sessions per participant. Target adherence rate ≥95% to demonstrate intervention feasibility.

    Postoperative Day 1 to Postoperative Day 3

Secondary Outcomes (4)

  • Number of participants with delirium as assessed by 4AT (4 'A's Test) screening tool

    From postoperative day 1 to end of study participation (up to 2 weeks)

  • Length of stay in study ward measured in days

    From admission to pilot ward until discharge/transfer from pilot ward (up to 2 weeks)

  • Number of participants actively participating in prescribed physiotherapy and occupational therapy sessions

    From postoperative day 1 to postoperative day 3

  • Cumulative analgesic consumption

    From postoperative day 1 to postoperative day 3

Study Arms (2)

Audio-Recorded Reorientation Intervention

EXPERIMENTAL

Participants in this arm receive personalized audio-recorded reorientation messages delivered three times daily during the first three post-operative days. Each message lasts approximately 2 minutes and contains personalized information including the current location, date and time, and encouraging messages. Messages are delivered via iPad and headphones by nursing staff during routine care. Audio messages are available in English, Mandarin, Malay, and Tamil to accommodate patient language preferences. Participants also receive all standard post-operative care and treatments.

Behavioral: Audio-Recorded Reorientation Intervention

Standard Care Control

NO INTERVENTION

Participants in this arm receive standard hip fracture care according to the hospital's established hip fracture pathway. Standard care includes early mobilization with sitting out of bed three times daily, allied health professional involvement (physiotherapist, occupational therapist, and dietitian), and routine orientation assessment. Participants found to be disoriented are screened for delirium using the validated 4AT assessment tool administered by nursing staff. Those identified as at-risk or experiencing delirium receive a comprehensive delirium care bundle including environmental modifications, medication review, and enhanced monitoring. Standard reorientation interventions include whiteboard orientation displays and purple wrist tags for participants at risk of cognitive impairment to ensure enhanced monitoring and fall prevention. No study-specific interventions are provided to this group beyond routine hospital care protocols.

Interventions

Participants in this arm receive personalized audio-recorded reorientation messages delivered three times daily during the first three post-operative days. Each message lasts approximately 2 minutes and contains personalized information including the current location, date and time, and encouraging messages. Messages are delivered via iPad and headphones by nursing staff during routine care. Audio messages are available in English, Mandarin, Malay, and Tamil to accommodate patient language preferences. Participants also receive all standard post-operative care and treatments.

Audio-Recorded Reorientation Intervention

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Older adults aged 60 years and above
  • Undergoing hip fracture repair surgery
  • No history of cognitive impairment as assessed by Abbreviated Mental Test (AMT)
  • Able to understand to any of the basic languages of Singapore (English, Malay, Mandarin, Tamil)

You may not qualify if:

  • Patients not admitted directly to orthopaedic (study) wards post-operation (such as those requiring post-operative high-dependency unit care)
  • Patients managed conservatively without surgical intervention.
  • Patients admitted for periprosthetic hip fracture repairs
  • Patients who are deaf and mute

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sengkang General Hospital

Singapore, 544886, Singapore

RECRUITING

Related Publications (2)

  • Munro CL, Cairns P, Ji M, Calero K, Anderson WM, Liang Z. Delirium prevention in critically ill adults through an automated reorientation intervention - A pilot randomized controlled trial. Heart Lung. 2017 Jul-Aug;46(4):234-238. doi: 10.1016/j.hrtlng.2017.05.002. Epub 2017 Jun 9.

    PMID: 28606450BACKGROUND
  • Kasapoglu ES, Enc N. Role of multicomponent non-pharmacological nursing interventions on delirium prevention: A randomized controlled study. Geriatr Nurs. 2022 Mar-Apr;44:207-214. doi: 10.1016/j.gerinurse.2022.02.015. Epub 2022 Feb 26.

    PMID: 35227973BACKGROUND

MeSH Terms

Conditions

Emergence DeliriumDelirium

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental Disorders

Central Study Contacts

Elaine Goh, RN, BSN

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Group 1 (intervention group): Audio reorientation intervention + usual care Group 2 (control group): Usual care only Both groups studied simultaneously with the same time period.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2025

First Posted

February 9, 2026

Study Start

September 29, 2025

Primary Completion

May 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

February 9, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to the pilot nature of this feasibility study with a small sample size. Aggregate results and study findings will be made available through peer-reviewed publications and conference presentations. The study protocol and statistical analysis plan will be made publicly available.

Locations