Effect of Music on the Clinical outcome after Hip fracture OPeratIoNs (MCHOPIN): a multicenter randomized controlled trial

Recruiting

• Conditions: broken hip; proximal femur fracture; 10005944

• Registration Number: NL-OMON52816
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 452

Inclusion Criteria

1. Patients with a proximal femur fracture undergoing surgical treatment
2. Age >= 65 years old
3. Provision of written informed consent by patient or proxy

Exclusion Criteria

1. Additional serious injuries or additional surgical procedures that may
affect any of the outcome parameters
2. Simultaneous bilateral hip fracture
3. Implant in situ in the affected hip
4. Severe hearing impairment, defined as no verbal communication possible
5. Patients unwilling or unable to comply with the intervention
6. Preoperative planned hospital discharge and return to nursing home within 48
hours of admission
7. Insufficient knowledge of the Dutch or English language to understand the
study documents in the judgement of the attending physician or researcher
8. Participation in another intervention study that might influence the
duration of surgery or any of the outcome parameters

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Delirium</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes are:<br /><br>- Pain (Numeric Rating Scale (NRS; care as usual))<br /><br>- Anxiety (State-Trait Anxiety Inventory 6 (STAI-6))<br /><br>- Medication requirement<br /><br>- Postoperative complications<br /><br>- Hospital length of stay<br /><br>- Nursing home length of stay<br /><br>- 30-day mortality<br /><br>- 90-day readmission<br /><br>- 90-day Katz-ADL-6<br /><br>- Costs</p><br>