The Efficacy of Music in Preventing Delirium in Elderly Patients With Hip Fracture

NCT06209788 | Unknown DMC

• 1 other identifier: CYCH2023084
• Study Type: interventional
• Target: 102
• Locations: 0 countries
• Sites: N/A

Brief 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. 1.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.
2. 2.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.

Conditions

Delirium in Old Age; Hip Fractures

Keywords

delirium; hip fracture; music; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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.

  7-14 days

Secondary Outcomes (5)

• opioid analgesic usage

  7-14 days

• postoperative complications

  1 month

• length of hospital stay

  7-14 days

• readmission within 14 days postoperatively

  1 month

• 30-day mortality

  1 month

Study Arms (2)

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.

Procedure: experimental group

Control group

NO INTERVENTION

Routine post-operative care.

Interventions

experimental group PROCEDURE

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.

Experimental group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Related Publications (16)

• 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.

  PMID: 25535170 RESULT

• Chen 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.

  PMID: 36620772 RESULT

• Chlan 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.

  PMID: 23689789 RESULT

• Esfahanian 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.

  PMID: 36241502 RESULT

• Fu 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.

  PMID: 34949611 RESULT

• Golubovic 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.

  PMID: 35624955 RESULT

• Haynes 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.

  PMID: 33989253 RESULT

• Igwe 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.

  PMID: 32768990 RESULT

• Johnson 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.

  PMID: 29735284 RESULT

• Kang 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.

  PMID: 35718628 RESULT

• Oh 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.

  PMID: 28973626 RESULT

• Qi 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.

  PMID: 35992597 RESULT

• Ravi 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.

  PMID: 30794305 RESULT

• Shin 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.

  PMID: 27809817 RESULT

• Wu 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.

  PMID: 32833302 RESULT

• Chao LY, Lin CC, Wang L, Lu HJ, Chen JL, Ku HC. Effect of music listening on delirium after hip fracture operations (MLDHFO) in a regional hospital in Taiwan: a randomised controlled trial protocol. BMJ Open. 2025 Aug 6;15(8):e095492. doi: 10.1136/bmjopen-2024-095492.

  PMID: 40774707 DERIVED

MeSH Terms

Conditions

Hip Fractures; Delirium

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Ku Han-Chang, Assistant Professor

CONTACT

886-5-3628800; hcku@mail.cgust.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD & Assistant Professor, RN

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: January 18, 2024
• Study Start: January 15, 2024
• Primary Completion: December 5, 2024
• Study Completion: December 5, 2024
• Last Updated: January 19, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share