No registrations found.
ID
Source
Brief title
Health condition
Proximal femur fracture
Delirium
Sponsors and support
Rotterdam
Department of Surgery
P.O. Box 2040, 3000 CA Rotterdam, The Netherlands
Intervention
Outcome measures
Primary outcome
Delirium (DOS scale and clinical diagnosis by geriatrician)
Secondary outcome
- 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)
Background summary
Proximal femur fractures are the most common fractures in the elderly. These
elderly patients, often with significant comorbidity and polypharmacy, are at high risk for
delirium, which increases the risk of other postoperative complications, a longer hospital stay
and a reduced functional outcome. Recent systematic reviews and meta-analysis have
shown a significant beneficial effect of perioperative music on postoperative pain and
anxiety. Also, several studies have shown a reduced need for intraoperative sedative
medication, as well as a reduction in postoperative analgesic medication requirement, when
perioperative music as a non-pharmacological intervention was used. This study will
investigate the effect of perioperative music on the clinical outcome in proximal femur
fracture patients. The main objective of this study is to investigate whether music as an intervention is effective in reducing the occurrence of postoperative delirium. Secondary objectives are the effects of perioperative music on pain, anxiety, medication use, postoperative
complications, neurohormonal stress response, hospital length of stay, nursing home length
of stay, 30-day mortality, 90-day readmission, 90-day functional ability to perform daily living
activities and costs.
Study objective
Proximal femur fractures are the most common fractures in the elderly. These elderly patients, often with significant comorbidity and polypharmacy, are at high risk for delirium, which increases the risk of other postoperative complications, a longer hospital stay and a reduced functional outcome. Perioperative music has a significant beneficial effect on anxiety and postoperative pain, which are risk factors of delirium. The main objective of this study is to investigate whether music as an intervention is effective in reducing the occurrence of postoperative delirium.
Study design
90-days
Intervention
Perioperative recorded music
V.X. Fu
P.O. Box 2040
Rotterdam 3000 CA
The Netherlands
v.fu@erasmusmc.nl
V.X. Fu
P.O. Box 2040
Rotterdam 3000 CA
The Netherlands
v.fu@erasmusmc.nl
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
- 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
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6858 |
| NTR-old | NTR7036 |
| CCMO | NL64721.078.18 |
| OMON | NL-OMON52816 |