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,…
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Delirium
Secondary outcome
Secondary outcomes are:
- Pain (Numeric Rating Scale (NRS; care as usual))
- Anxiety (State-Trait Anxiety Inventory 6 (STAI-6))
- Medication requirement
- Postoperative complications
- Hospital length of stay
- Nursing home length of stay
- 30-day mortality
- 90-day readmission
- 90-day Katz-ADL-6
- 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.
Study objective
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, 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 design
Multicenter randomized controlled trial.
Intervention
The intervention group will receive pre-operative, intraoperative and
postoperative music as an intervention, the control group will not receive the
music intervention. All patients will wear headphones before and during
surgery. Patients in the intervention group can choose their preferred music.
Study burden and risks
Music has no known adverse effects. A lock on the music volume will be
implemented to limit music volume. Part of the measurements and data collection
is embedded in standard postoperative care, and part will be collected solely
for study purposes, consisting of three questionnaires. All data will be
collected during hospital stay and during one standard regular postoperative
follow-up hospital visit. No additional hospital visits are necessary for this
study. The study will be performed in proximal femur fracture surgery patients
because of the high level of postoperative pain and high risk of delirium and
other major postoperative complications in this study population, which
influence length of hospital stay and costs. Incapacitated patients with
dementia will be included, as this is a significant part of the target
population with a substantially higher risk of delirium and postoperative
complications. Overall, the burden and risks associated with this study are
negligible.
Doctor Molewaterplein 40
Rotterdam 3015 GD
NL
Doctor Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| Other | Nederlands Trial Register: NTR7036 |
| CCMO | NL64721.078.18 |
| OMON | NL-OMON25655 |