The Efficacy of Music in Preventing Delirium in Elderly Patients With Hip Fracture: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 102
- 主要终点
- delirium event and severity
研究概览
简要总结
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:
- 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.
- 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
delirium event and severity
时间窗: 7-14 days
Delirium is diagnosed based on clinical symptoms, utilizing the Confusion Assessment Method (CAM) to assess. CAM consists of four elements that can be quickly completed in a hospital setting, making it a convenient diagnostic tool. The four components include abrupt onset, fluctuating course of symptoms, inattention, and disorganized thinking or altered level of consciousness.
次要结局
- opioid analgesic usage(7-14 days)
- readmission within 14 days postoperatively(1 month)
- 30-day mortality(1 month)
- length of hospital stay(7-14 days)
- postoperative complications(1 month)
研究者
Han-Chang Ku
PhD & Assistant Professor, RN
Chang Gung University of Science and Technology