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

Hip Fractures Clinical Trial

Official title:

The Efficacy of Music in Preventing Delirium in Elderly Patients With Hip Fracture: A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06209788
• Other study ID #: CYCH2023084
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 15, 2024
• Est. completion date: December 5, 2024

Study information

• Verified date: January 2024
• Source: Chang Gung Memorial Hospital
• Contact: Ku Han-Chang, Assistant Professor
• Phone: 886-5-3628800
• Email: hcku[@]mail.cgust.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 102
• Est. completion date: December 5, 2024
• Est. primary completion date: December 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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:

• 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.

Related Conditions & MeSH terms

• Delirium
• Delirium in Old Age
• Fractures, Bone
• Hip Fractures

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

References & Publications (15)

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 — View Citation

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. — View Citation

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 tr — View Citation

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 — View Citation

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 randomise — View Citation

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. — View Citation

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 — View Citation

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 — View Citation

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 — View Citation

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):640-6 — View Citation

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. — View Citation

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 20 — View Citation

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.2019.0 — View Citation

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. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	opioid analgesic usage	Comparison of patients' opioid analgesic dosage and frequency during hospitalization.	7-14 days
Secondary	postoperative complications	Comparison of surgical complications occurring during hospitalization or within one month post-discharge.	1 month
Secondary	length of hospital stay	Comparison of patients' length of hospital stay during hospitalization.	7-14 days
Secondary	readmission within 14 days postoperatively	Recording whether patients are readmitted within 14 days post-discharge due to surgical complications or delirium.	1 month
Secondary	30-day mortality	Recording whether patients die within 30 days post-discharge due to surgical complications or delirium issues.	1 month