Clinical trial NCT06209788: The Efficacy of Music in Preventing Delirium in Elderly Patients With Hip Fracture
Official title: The Efficacy of Music in Preventing Delirium in Elderly Patients With Hip Fracture: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Delirium in Old Age
Hip Fractures
Keywords: delirium
hip fracture
music
randomized controlled trial
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2024-01-18
Enrollment: 102
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: delirium event and severity
timeFrame: 7-14 days
Secondary outcomes:
measure: opioid analgesic usage
timeFrame: 7-14 days
measure: postoperative complications
timeFrame: 1 month
measure: length of hospital stay
timeFrame: 7-14 days
measure: readmission within 14 days postoperatively
timeFrame: 1 month
measure: 30-day mortality
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
References:
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