Delirium - PostoperativeNCT07396532
Audio-Recorded Messages Delivered Via iPad to Prevent Delirium in Hip Fracture Patients
A study testing Audio-Recorded Reorientation Intervention in people with Delirium - Postoperative and Delirium and Post-operative Cognitive Dysfunction (POCD), run by Sengkang General Hospital at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Delirium - Postoperative, Delirium and Post-operative Cognitive Dysfunction (POCD), Delirium, Postoperative
- What is being tested?
- Audio-Recorded Reorientation Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSingapore
- Study dates
- 29 Sep 2025to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site, 1 recruiting
- Recruiting
Sengkang General Hospital
Singapore, 544886
Elaine Goh, RN, BSN, +65 82288624, elaine.goh.sh@skh.com.sg
Elaine Goh, RN, BSN
About this study
Official title: Nurse-Led Audio-Recorded Reorientation to Reduce Delirium in Elderly Hip Fractures: A Pilot Randomized Control Trial
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?
Read more
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.
Read the 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.
- Conditions
- Delirium - Postoperative, Delirium and Post-operative Cognitive Dysfunction (POCD), Delirium, Postoperative
- Being tested
- Audio-Recorded Reorientation Intervention
- Keywords
- delirium, nurse-led, reality reorientation, AI
- Medical subject headings
- Emergence Delirium, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audio-Recorded Reorientation InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Delirium will be assessed using the 4AT (4 'A's Test), a validated 4-item screening instrument that evaluates alertness, attention (months backwards), acute change or fluctuating course, and AMT4 (age, date of birth, place, current year). The 4AT score ranges from 0-12, with scores ≥4 indicating possible delirium and scores ≥1 suggesting cognitive impairment. Delirium incidence will be reported as the number and percentage of participants who score ≥4 on the 4AT during their study participation period.
Measured: From postoperative day 1 to end of study participation (up to 2 weeks)
Length of stay in study ward measured in days
Length of stay will be measured as the total number of days from admission to the pilot ward until discharge from the pilot ward (either to home, transfer to another ward, or transfer to community hospital). This measure captures only the time spent specifically in the study/pilot ward and does not include any subsequent stays in other wards or facilities. Length of stay will be calculated in whole days and reported as mean, median, and range.
Measured: 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
Allied health participation will be measured as the number and percentage of participants who actively engage in their prescribed physiotherapy (PT) and occupational therapy (OT) sessions during their stay in the pilot ward. Participation will be defined as attending and actively engaging in therapy sessions as documented by the treating therapists. Since all hip fracture patients receive standard PT/OT orders, this outcome measures engagement rather than referral rates. Data will be collected through therapy documentation review.
Measured: From postoperative day 1 to postoperative day 3
Cumulative analgesic consumption
Analgesic consumption will be measured as the total cumulative dose of commonly prescribed analgesics (morphine, paracetamol, and oxycodone) consumed by participants during post-operative days 1 to 3. All doses will be recorded in their respective units (morphine in mg, paracetamol in mg, oxycodone in mg) from medication administration records. This outcome assesses whether improved orientation and medication compliance messaging through the audio-recorded intervention affects analgesic usage patterns. Data will include both scheduled and PRN (as needed) doses administered.
Measured: From postoperative day 1 to postoperative day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start29 Sep 2025
- Primary completionMay 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Delirium - PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sengkang General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07396532
- Sponsor's protocol ID
- 2025-0733
- Other IDs
- CIRB-2025-0733
- Status last verified
- Feb 2026
- First submitted
- 3 Dec 2025
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 28606450Kasapoglu 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.
PubMed 35227973
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nurse-Led Audio-Recorded Reorientation to Reduce Delirium in Elderly Hip Fractures: A Pilot Randomized Control Trial
- ClinicalTrials.gov ID
- NCT07396532
- Acronym / sponsor ID
- 2025-0733
- Conditions
- Delirium - Postoperative, Delirium and Post-operative Cognitive Dysfunction (POCD), Delirium, Postoperative
- Keywords
- delirium, nurse-led, reality reorientation, AI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sengkang General HospitalUniversity, hospital or other
- Study start
- 29 Sep 2025 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Audio-Recorded Reorientation Intervention | Experimental | Behavioral: Audio-Recorded Reorientation InterventionParticipants 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. |
| 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Audio-Recorded Reorientation InterventionParticipants 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. | Behavioural | Audio-Recorded Reorientation Intervention |
Primary outcome
Protocol Adherence Rate
Time frame: Postoperative day 1 to postoperative day 3
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.
Recruitment Feasibility
Time frame: From enrollment to end of study participation (up to 2 weeks)
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.
Study Retention Rate
Time frame: From enrollment to end of study participation (up to 2 weeks)
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.
Intervention Tolerance Rate
Time frame: Postoperative Day 1 to Postoperative Day 3
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.
4 secondary outcomes
Number of participants with delirium as assessed by 4AT (4 'A's Test) screening tool
Time frame: From postoperative day 1 to end of study participation (up to 2 weeks)
Length of stay in study ward measured in days
Time frame: 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
Time frame: From postoperative day 1 to postoperative day 3
Cumulative analgesic consumption
Time frame: From postoperative day 1 to postoperative day 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Background: PubMed 28606450Munro 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.
- Background: PubMed 35227973Kasapoglu 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Audio-Recorded Reorientation Intervention in people with Delirium - Postoperative and Delirium and Post-operative Cognitive Dysfunction (POCD), run by Sengkang General Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elaine Goh, RN, BSN (+65 82288624, elaine.goh.sh@skh.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Protocol Adherence Rate (time frame: Postoperative day 1 to postoperative day 3). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07396532, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.