Delirium in Old AgeNCT06209788
The Efficacy of Music in Preventing Delirium in Elderly Patients With Hip Fracture
A study testing experimental group in people with Delirium in Old Age and Hip Fractures, run by Chang Gung Memorial Hospital.
Trial summary
The aim of this trial is to explore the efficacy of music in preventing delirium in elderly patients with hip fracture. The main aims of this research are: 1. To compare the effectiveness of music intervention in preventing delirium in patients with hip fractures through a randomized controlled trial. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Delirium in Old Age, Hip Fractures
- What is being tested?
- experimental group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2024to 5 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 65 years and above (inclusive).
- Individuals with clear consciousness and willingness to participate in this study.
- The primary treating physician of the participant must be the principal investigator or co-principal investigator of this study.
- Diagnosis of femoral head fracture, femoral neck fracture, or intertrochanteric fracture.
- Surgical procedures include hip hemiarthroplasty, total hip arthroplasty, cannulated screw fixation, dynamic hip screw, femoral neck system, and gamma-nail.
Who cannot join
- Bilateral hip fractures simultaneously.
- History of neurosurgery.
- Preoperative delirium.
- Severe hearing impairment (unable to engage in oral conversation).
- Use of sedatives or antidepressant medications.
- Dementia or psychiatric disorders.
Show all 10Show fewer
- Patient unwilling to participate in the study or cooperate with listening to music (using headphones).
- Use of unknown medications and alcohol.
- After taking antihypertensive medication, preoperative systolic blood pressure >200 mmHg or diastolic blood pressure >110 mmHg.
- Preoperative heart rate >130 beats per minute or <50 beats per minute.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Efficacy of Music in Preventing Delirium in Elderly Patients With Hip Fracture: A Randomized Controlled Trial
The aim of this trial is to explore the efficacy of music in preventing delirium in elderly patients with hip fracture.
The main aims of this research are:
- To compare the effectiveness of music intervention in preventing delirium in patients with hip fractures through a randomized controlled trial. The comparisons include respiratory rate, pulse rate, blood pressure, and pain score, as well as the incidence and severity of delirium, opioid analgesic usage, postoperative complications, length of hospital stay, and rates of readmission within 14 days and 30-day mortality.
- Introduce the evidence-based ''listening music protocol'' in the care of hip fracture patients to prevent delirium, and test the effects through a randomized controlled trial.
Read the detailed description
This study is a two-group, pre and post-test, randomized controlled trial to test the effectiveness of the ''listening music protocol''. Convenience sampling will be used to select the inpatients with hip fractures in a regional hospital in southern Taiwan. 102 participants will be randomly assigned either to an experimental (n=51) or to a control (n=51) group. The experimental group will receive a six-day music protocol and regular post-operative care. The control group will receive regular post-operative care only. Statistical analysis was performed using SPSS Version 22.0.
Descriptive statistics, including frequencies, percentages, means, and medians, were used to analyze basic attributes. For the analysis of homogeneity, the chi-square test or Fisher's exact test was employed for categorical variables. The paired t-test was used to compare respiratory rate, pulse rate, blood pressure, and pain index.
Following the intervention, the occurrence and severity of delirium before and after implementing music intervention were compared. Additionally, comparisons were made for opioid analgesic usage, postoperative complications, length of hospital stay, and 30-day mortality.
- Conditions
- Delirium in Old Age, Hip Fractures
- Being tested
- experimental group
- Keywords
- delirium, hip fracture, music, randomized controlled trial
- Medical subject headings
- Hip Fractures, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
experimental groupProcedure or surgery
The music intervention consists of two parts. The first part occurs during the surgical procedure, starting from the induction of anesthesia and continuing until the surgery over. The second part spans from the first day post-surgery to the fifth day (or until discharge), with the patient listening to music twice a day, each session lasting for 30 minutes. The planned times for the music sessions are expected to be at 11 a.m. and 8 p.m. Each day post-surgery, the music intervention must be completed, and measurements of respiratory rate, pulse rate, blood pressure, and pain score should be taken both before and after listening to the music. Other are routine post-operative care.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The music intervention consists of two parts. The first part occurs during the surgical procedure, starting from the induction of anesthesia and continuing until the surgery over. The second part spans from the first day post-surgery to the fifth day (or until discharge), with the patient listening to music twice a day, each session lasting for 30 minutes. The planned times for the music sessions are expected to be at 11 a.m. and 8 p.m. Each day post-surgery, the music intervention must be completed, and measurements of respiratory rate, pulse rate, blood pressure, and pain score should be taken both before and after listening to the music. Other are routine post-operative care. Receives: Procedure: experimental group |
| Control group | No intervention | Routine post-operative care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
delirium event and severity
Delirium is diagnosed based on clinical symptoms, utilizing the Confusion Assessment Method (CAM) to assess. CAM consists of four elements that can be quickly completed in a hospital setting, making it a convenient diagnostic tool. The four components include abrupt onset, fluctuating course of symptoms, inattention, and disorganized thinking or altered level of consciousness.
Measured: 7-14 days
Secondary outcomes (5)
opioid analgesic usage
Comparison of patients' opioid analgesic dosage and frequency during hospitalization.
Measured: 7-14 days
postoperative complications
Comparison of surgical complications occurring during hospitalization or within one month post-discharge.
Measured: 1 month
length of hospital stay
Comparison of patients' length of hospital stay during hospitalization.
Measured: 7-14 days
readmission within 14 days postoperatively
Recording whether patients are readmitted within 14 days post-discharge due to surgical complications or delirium.
Measured: 1 month
30-day mortality
Recording whether patients die within 30 days post-discharge due to surgical complications or delirium issues.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start15 Jan 2024 (estimated)
- Primary completion5 Dec 2024 (estimated)
- Study completion5 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Delirium in Old AgeStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han-Chang Ku, Chang Gung University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06209788
- Sponsor's protocol ID
- CYCH2023084
- Status last verified
- Jan 2024
- First submitted
- 8 Jan 2024
- Last updated
- 19 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
American Geriatrics Society Expert Panel on Postoperative Delirium in Older Adults. Postoperative delirium in older adults: best practice statement from the American Geriatrics Society. J Am Coll Surg. 2015 Feb;220(2):136-48.e1. doi: 10.1016/j.jamcollsurg.2014.10.019. Epub 2014 Nov 14. No abstract available.
PubMed 25535170Chen Y, Liang S, Wu H, Deng S, Wang F, Lunzhu C, Li J. Postoperative delirium in geriatric patients with hip fractures. Front Aging Neurosci. 2022 Dec 22;14:1068278. doi: 10.3389/fnagi.2022.1068278. eCollection 2022.
PubMed 36620772Chlan LL, Weinert CR, Heiderscheit A, Tracy MF, Skaar DJ, Guttormson JL, Savik K. Effects of patient-directed music intervention on anxiety and sedative exposure in critically ill patients receiving mechanical ventilatory support: a randomized clinical trial. JAMA. 2013 Jun 12;309(22):2335-44. doi: 10.1001/jama.2013.5670.
PubMed 23689789Esfahanian F, Mirmohammadsadeghi A, Gholami H, Neshat S, Mansouri M, Sadeghi M, Bathaie SR, Heidari Z, Mirmohammadsadeghi M. Using Music for the Prevention of Delirium in Patients After Coronary Artery Bypass Graft Surgery: A Randomized Clinical Trial. J Cardiothorac Vasc Anesth. 2022 Dec;36(12):4341-4346. doi: 10.1053/j.jvca.2022.09.007. Epub 2022 Sep 9.
PubMed 36241502Fu VX, Jeekel J, Van Lieshout EMM, Van der Velde D, Slegers LJP, Haverlag R, Haumann J, Poley MJ, Verhofstad MHJ; MCHOPIN collaborators. Effect of music on clinical outcome after hip fracture operations (MCHOPIN): study protocol of a multicentre randomised controlled trial. BMJ Open. 2021 Dec 23;11(12):e049706. doi: 10.1136/bmjopen-2021-049706.
PubMed 34949611Golubovic J, Neerland BE, Aune D, Baker FA. Music Interventions and Delirium in Adults: A Systematic Literature Review and Meta-Analysis. Brain Sci. 2022 Apr 28;12(5):568. doi: 10.3390/brainsci12050568.
PubMed 35624955Haynes MS, Alder KD, Toombs C, Amakiri IC, Rubin LE, Grauer JN. Predictors and Sequelae of Postoperative Delirium in a Geriatric Patient Population With Hip Fracture. J Am Acad Orthop Surg Glob Res Rev. 2021 May 14;5(5):e20.00221. doi: 10.5435/JAAOSGlobal-D-20-00221.
PubMed 33989253Igwe EO, Nealon J, Mohammed M, Hickey B, Chou KR, Chen KH, Traynor V. Multi-disciplinary and pharmacological interventions to reduce post-operative delirium in elderly patients: A systematic review and meta-analysis. J Clin Anesth. 2020 Dec;67:110004. doi: 10.1016/j.jclinane.2020.110004. Epub 2020 Aug 5.
PubMed 32768990Johnson K, Fleury J, McClain D. Music intervention to prevent delirium among older patients admitted to a trauma intensive care unit and a trauma orthopaedic unit. Intensive Crit Care Nurs. 2018 Aug;47:7-14. doi: 10.1016/j.iccn.2018.03.007. Epub 2018 May 4.
PubMed 29735284Kang J, Cho YS, Lee M, Yun S, Jeong YJ, Won YH, Hong J, Kim S. Effects of nonpharmacological interventions on sleep improvement and delirium prevention in critically ill patients: A systematic review and meta-analysis. Aust Crit Care. 2023 Jul;36(4):640-649. doi: 10.1016/j.aucc.2022.04.006. Epub 2022 Jun 17.
PubMed 35718628Oh ES, Fong TG, Hshieh TT, Inouye SK. Delirium in Older Persons: Advances in Diagnosis and Treatment. JAMA. 2017 Sep 26;318(12):1161-1174. doi: 10.1001/jama.2017.12067.
PubMed 28973626Qi YM, Li YJ, Zou JH, Qiu XD, Sun J, Rui YF. Risk factors for postoperative delirium in geriatric patients with hip fracture: A systematic review and meta-analysis. Front Aging Neurosci. 2022 Aug 3;14:960364. doi: 10.3389/fnagi.2022.960364. eCollection 2022.
PubMed 35992597Ravi B, Pincus D, Choi S, Jenkinson R, Wasserstein DN, Redelmeier DA. Association of Duration of Surgery With Postoperative Delirium Among Patients Receiving Hip Fracture Repair. JAMA Netw Open. 2019 Feb 1;2(2):e190111. doi: 10.1001/jamanetworkopen.2019.0111.
PubMed 30794305Shin JE, Kyeong S, Lee JS, Park JY, Lee WS, Kim JJ, Yang KH. A personality trait contributes to the occurrence of postoperative delirium: a prospective study. BMC Psychiatry. 2016 Nov 3;16(1):371. doi: 10.1186/s12888-016-1079-z.
PubMed 27809817Wu J, Yin Y, Jin M, Li B. The risk factors for postoperative delirium in adult patients after hip fracture surgery: a systematic review and meta-analysis. Int J Geriatr Psychiatry. 2021 Jan;36(1):3-14. doi: 10.1002/gps.5408. Epub 2020 Oct 29.
PubMed 32833302
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Music in Preventing Delirium in Elderly Patients With Hip Fracture: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06209788
- Acronym / sponsor ID
- CYCH2023084
- Conditions
- Delirium in Old Age, Hip Fractures
- Keywords
- delirium, hip fracture, music, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 15 Jan 2024 (estimated)
- Primary completion
- 5 Dec 2024 (estimated)
- Study completion
- 5 Dec 2024 (estimated)
- First posted
- 18 Jan 2024 (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 aim of this trial is to explore the efficacy of music in preventing delirium in elderly patients with hip fracture.
The main aims of this research are:
- To compare the effectiveness of music intervention in preventing delirium in patients with hip fractures through a randomized controlled trial. The comparisons include respiratory rate, pulse rate, blood pressure, and pain score, as well as the incidence and severity of delirium, opioid analgesic usage, postoperative complications, length of hospital stay, and rates of readmission within 14 days and 30-day mortality.
- Introduce the evidence-based ''listening music protocol'' in the care of hip fracture patients to prevent delirium, and test the effects through a randomized controlled trial.
Detailed description
This study is a two-group, pre and post-test, randomized controlled trial to test the effectiveness of the ''listening music protocol''. Convenience sampling will be used to select the inpatients with hip fractures in a regional hospital in southern Taiwan. 102 participants will be randomly assigned either to an experimental (n=51) or to a control (n=51) group. The experimental group will receive a six-day music protocol and regular post-operative care. The control group will receive regular post-operative care only. Statistical analysis was performed using SPSS Version 22.0.
Descriptive statistics, including frequencies, percentages, means, and medians, were used to analyze basic attributes. For the analysis of homogeneity, the chi-square test or Fisher's exact test was employed for categorical variables. The paired t-test was used to compare respiratory rate, pulse rate, blood pressure, and pain index.
Following the intervention, the occurrence and severity of delirium before and after implementing music intervention were compared. Additionally, comparisons were made for opioid analgesic usage, postoperative complications, length of hospital stay, and 30-day mortality.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Procedure: experimental groupThe music intervention consists of two parts. The first part occurs during the surgical procedure, starting from the induction of anesthesia and continuing until the surgery over. The second part spans from the first day post-surgery to the fifth day (or until discharge), with the patient listening to music twice a day, each session lasting for 30 minutes. The planned times for the music sessions are expected to be at 11 a.m. and 8 p.m. Each day post-surgery, the music intervention must be completed, and measurements of respiratory rate, pulse rate, blood pressure, and pain score should be taken both before and after listening to the music. Other are routine post-operative care. |
| Control group | No intervention | –Routine post-operative care. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 65 years and above (inclusive).
- Individuals with clear consciousness and willingness to participate in this study.
- The primary treating physician of the participant must be the principal investigator or co-principal investigator of this study.
- Diagnosis of femoral head fracture, femoral neck fracture, or intertrochanteric fracture.
- Surgical procedures include hip hemiarthroplasty, total hip arthroplasty, cannulated screw fixation, dynamic hip screw, femoral neck system, and gamma-nail.
Key exclusion criteria (10 listed)
- Bilateral hip fractures simultaneously.
- History of neurosurgery.
- Preoperative delirium.
- Severe hearing impairment (unable to engage in oral conversation).
- Use of sedatives or antidepressant medications.
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 |
|---|---|---|
| experimental groupThe music intervention consists of two parts. The first part occurs during the surgical procedure, starting from the induction of anesthesia and continuing until the surgery over. The second part spans from the first day post-surgery to the fifth day (or until discharge), with the patient listening to music twice a day, each session lasting for 30 minutes. The planned times for the music sessions are expected to be at 11 a.m. and 8 p.m. Each day post-surgery, the music intervention must be completed, and measurements of respiratory rate, pulse rate, blood pressure, and pain score should be taken both before and after listening to the music. Other are routine post-operative care. | Procedure or surgery | Experimental group |
Primary outcome
delirium event and severity
Time frame: 7-14 days
Delirium is diagnosed based on clinical symptoms, utilizing the Confusion Assessment Method (CAM) to assess. CAM consists of four elements that can be quickly completed in a hospital setting, making it a convenient diagnostic tool. The four components include abrupt onset, fluctuating course of symptoms, inattention, and disorganized thinking or altered level of consciousness.
5 secondary outcomes
opioid analgesic usage
Time frame: 7-14 days
postoperative complications
Time frame: 1 month
length of hospital stay
Time frame: 7-14 days
readmission within 14 days postoperatively
Time frame: 1 month
30-day mortality
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
- Results publication: PubMed 25535170American Geriatrics Society Expert Panel on Postoperative Delirium in Older Adults. Postoperative delirium in older adults: best practice statement from the American Geriatrics Society. J Am Coll Surg. 2015 Feb;220(2):136-48.e1. doi: 10.1016/j.jamcollsurg.2014.10.019. Epub 2014 Nov 14. No abstract available.
- Results publication: PubMed 36620772Chen Y, Liang S, Wu H, Deng S, Wang F, Lunzhu C, Li J. Postoperative delirium in geriatric patients with hip fractures. Front Aging Neurosci. 2022 Dec 22;14:1068278. doi: 10.3389/fnagi.2022.1068278. eCollection 2022.
- Results publication: PubMed 23689789Chlan LL, Weinert CR, Heiderscheit A, Tracy MF, Skaar DJ, Guttormson JL, Savik K. Effects of patient-directed music intervention on anxiety and sedative exposure in critically ill patients receiving mechanical ventilatory support: a randomized clinical trial. JAMA. 2013 Jun 12;309(22):2335-44. doi: 10.1001/jama.2013.5670.
- Results publication: PubMed 36241502Esfahanian F, Mirmohammadsadeghi A, Gholami H, Neshat S, Mansouri M, Sadeghi M, Bathaie SR, Heidari Z, Mirmohammadsadeghi M. Using Music for the Prevention of Delirium in Patients After Coronary Artery Bypass Graft Surgery: A Randomized Clinical Trial. J Cardiothorac Vasc Anesth. 2022 Dec;36(12):4341-4346. doi: 10.1053/j.jvca.2022.09.007. Epub 2022 Sep 9.
- Results publication: PubMed 34949611Fu VX, Jeekel J, Van Lieshout EMM, Van der Velde D, Slegers LJP, Haverlag R, Haumann J, Poley MJ, Verhofstad MHJ; MCHOPIN collaborators. Effect of music on clinical outcome after hip fracture operations (MCHOPIN): study protocol of a multicentre randomised controlled trial. BMJ Open. 2021 Dec 23;11(12):e049706. doi: 10.1136/bmjopen-2021-049706.
- Results publication: PubMed 35624955Golubovic J, Neerland BE, Aune D, Baker FA. Music Interventions and Delirium in Adults: A Systematic Literature Review and Meta-Analysis. Brain Sci. 2022 Apr 28;12(5):568. doi: 10.3390/brainsci12050568.
- Results publication: PubMed 33989253Haynes MS, Alder KD, Toombs C, Amakiri IC, Rubin LE, Grauer JN. Predictors and Sequelae of Postoperative Delirium in a Geriatric Patient Population With Hip Fracture. J Am Acad Orthop Surg Glob Res Rev. 2021 May 14;5(5):e20.00221. doi: 10.5435/JAAOSGlobal-D-20-00221.
- Results publication: PubMed 32768990Igwe EO, Nealon J, Mohammed M, Hickey B, Chou KR, Chen KH, Traynor V. Multi-disciplinary and pharmacological interventions to reduce post-operative delirium in elderly patients: A systematic review and meta-analysis. J Clin Anesth. 2020 Dec;67:110004. doi: 10.1016/j.jclinane.2020.110004. Epub 2020 Aug 5.
- Results publication: PubMed 29735284Johnson K, Fleury J, McClain D. Music intervention to prevent delirium among older patients admitted to a trauma intensive care unit and a trauma orthopaedic unit. Intensive Crit Care Nurs. 2018 Aug;47:7-14. doi: 10.1016/j.iccn.2018.03.007. Epub 2018 May 4.
- Results publication: PubMed 35718628Kang J, Cho YS, Lee M, Yun S, Jeong YJ, Won YH, Hong J, Kim S. Effects of nonpharmacological interventions on sleep improvement and delirium prevention in critically ill patients: A systematic review and meta-analysis. Aust Crit Care. 2023 Jul;36(4):640-649. doi: 10.1016/j.aucc.2022.04.006. Epub 2022 Jun 17.
- Results publication: PubMed 28973626Oh ES, Fong TG, Hshieh TT, Inouye SK. Delirium in Older Persons: Advances in Diagnosis and Treatment. JAMA. 2017 Sep 26;318(12):1161-1174. doi: 10.1001/jama.2017.12067.
- Results publication: PubMed 35992597Qi YM, Li YJ, Zou JH, Qiu XD, Sun J, Rui YF. Risk factors for postoperative delirium in geriatric patients with hip fracture: A systematic review and meta-analysis. Front Aging Neurosci. 2022 Aug 3;14:960364. doi: 10.3389/fnagi.2022.960364. eCollection 2022.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing experimental group in people with Delirium in Old Age and Hip Fractures, run by Chang Gung Memorial Hospital.
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 5 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 19 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ku Han-Chang, Assistant Professor (886-5-3628800 ext. 2623, hcku@mail.cgust.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
delirium event and severity (time frame: 7-14 days). 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 NCT06209788, which also lists 16 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 19 Jan 2024.