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Effect van muziek op de klinische uitkomst na heupfractuur operaties (MCHOPIN): een multicenter gerandomiseerde studie

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25655
Enrollment
508
Registered
2018-02-23
Start date
2018-07-01
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Proximal femur fracture Delirium

Interventions

Perioperative recorded music

Sponsors

Erasmus MC, University Medical Center Rotterdam Department of Surgery P.O. Box 2040, 3000 CA Rotterdam, The Netherlands
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Patients with a proximal femur fracture undergoing surgical treatment - Age ¡Ý 65 years old - Provision of written informed consent by patient or proxy

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Delirium (DOS scale and clinical diagnosis by geriatrician)

Secondary

MeasureTime frame
- Pain (NRS) - Anxiety (STAI-6) - Medication use - Postoperative complications - Neurohormonal stress response (serum cortisol) - Hospital length of stay - 30-day mortality - Nursing home length of stay - 90-day readmission - 90-day functional ability to perform daily living activities (Katz-ADL6) - Cost analysis (direct medical costs)

Contacts

Public ContactV.X. Fu

Department of Surgery, Erasmus MC University Medical Center.

v.fu@erasmusmc.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)