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Not yet recruitingNCT06209788Updated Jan 19, 2024

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

An interventional study of experimental group in Delirium in Old Age and Hip Fractures, sponsored by Chang Gung Memorial Hospital. Not yet recruiting. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2024-01-19.

Sponsored by Chang Gung Memorial Hospital · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
102
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study 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. 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. 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.

02

Conditions studied

  • Delirium in Old Age
  • Hip Fractures

Keywords

  • delirium
  • hip fracture
  • music
  • randomized controlled trial
03

In context

Delirium

1,057 studies on the registry are indexed under Delirium; 238 are open to participants now.

This study's planned enrollment of 102 is below the median of 120 across 599 interventional studies indexed under Delirium.

Browse Delirium studies →

Lead sponsor

Chang Gung Memorial Hospital is the lead sponsor of 1,064 studies on the registry; 235 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
102 participants (estimated)

Study arms

  • Experimental
    Experimental group

    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

  • No intervention
    Control group

    Routine post-operative care.

Interventions

  • Procedureexperimental group

    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.

06

What researchers measure

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.

    Time frame: 7-14 days

Secondary outcomes

  1. opioid analgesic usage

    Comparison of patients' opioid analgesic dosage and frequency during hospitalization.

    Time frame: 7-14 days

  2. postoperative complications

    Comparison of surgical complications occurring during hospitalization or within one month post-discharge.

    Time frame: 1 month

  3. length of hospital stay

    Comparison of patients' length of hospital stay during hospitalization.

    Time frame: 7-14 days

  4. readmission within 14 days postoperatively

    Recording whether patients are readmitted within 14 days post-discharge due to surgical complications or delirium.

    Time frame: 1 month

  5. 30-day mortality

    Recording whether patients die within 30 days post-discharge due to surgical complications or delirium issues.

    Time frame: 1 month

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Study locations

No study locations are listed for this record.

08

References and documents

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 25535170 ↗
  • 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. PubMed 36620772 ↗
  • 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. PubMed 23689789 ↗
  • 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. PubMed 36241502 ↗
  • 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. PubMed 34949611 ↗
  • 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. PubMed 35624955 ↗
  • 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. PubMed 33989253 ↗
  • 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. PubMed 32768990 ↗
  • 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. PubMed 29735284 ↗
  • 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. PubMed 35718628 ↗
  • 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. PubMed 28973626 ↗
  • 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. PubMed 35992597 ↗
  • 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. PubMed 30794305 ↗
  • 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. PubMed 27809817 ↗
  • 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. PubMed 32833302 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06209788
Lead sponsor
Chang Gung Memorial Hospital
Responsible party
Han-Chang Ku (PhD & Assistant Professor, RN, Chang Gung University of Science and Technology) — Principal investigator
First posted
Jan 18, 2024
Start date
Jan 15, 2024 (estimated)
Primary completion
Dec 5, 2024 (estimated)
Completion
Dec 5, 2024 (estimated)
Last update
Jan 19, 2024

Study contacts

Ku Han-Chang, Assistant Professor
Contact
hcku@mail.cgust.edu.tw
886-5-3628800 ext. 2623

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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