Music Therapy as a Treatment for Delirium in Acutely Hospitalized Older Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Recruitment rate
研究概览
简要总结
The purpose of this study is to assess feasibility and potential effectiveness of two different music interventions for managing delirium symptoms in acute geriatric patients.
详细描述
Delirium is a neuropsychiatric syndrome characterized by an acute alteration in attention, awareness, arousal and cognition, precipitated by an acute illness, intoxication, trauma or surgery. It is highly prevalent in older, frail and acutely hospitalized patients, and associated with poor outcomes, with few effective treatment alternatives. Non-pharmacological interventions and music show promising effects.
This study protocol aims to determine whether music interventions (MIs) delivered by a credentialed music therapist, are feasible and effective for regulating delirium symptoms in acute geriatric patients and whether the standardized delirium tools are sensitive to detect observable responses. Primary, feasibility outcomes are evaluating recruitment rate, treatment fidelity and adherence, as well as feasibility and accuracy in data collection procedures. Main effect-outcome is delirium severity, but delirium duration, cognitive status, length of hospital stay, and medication use will also be recorded. The randomised repeated measures controlled trial design will record the participant responses before and after exposure to MIs (+/- 2 hours). Participants with delirium from an acute geriatric ward will be randomized to either live or recorded MI. Each intervention will be delivered to n=30 participants (n=60 in total), for 30 minutes, over three consecutive days. Ethical approval has been obtained from Regional Ethics Committee South East Norway.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Masking of the therapist and the participants will not be possible, due to the nature of the interventions. Additionally, the music therapist will need to be acquainted with the results of the randomization in order to tailor each individual intervention. Masking of the outcome assessors will be attempted, but is expected to be incomplete, since the assessors will have to related to both the patients directly and to the medical staff who are well-acquainted with the patients, and who both might accidentally reveal the treatment allocation. Outcome assessors will attempt to remind the medical staff to keep the allocation concealed at all times. In order to verify the masking, the assessors will be asked about their knowledge of the patients' allocation to the treatment groups upon the last completed assessment.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥ 65 and with delirium or possible delirium at admission or detected within the last 72 hours, and still present.
- •Appropriate informed consent is obtained.
- •Participants will not be excluded if they are under long term care and have comorbidities such as dementia or mild cognitive impairment.
- •Patients will not be excluded if they have Covid-19.
排除标准
- •Patients who were previously enrolled, and were readmitted during the study period will not be re-included.
- •The patients with severe hearing impairments, severe psychiatric conditions, and/or severe alcohol/substance addiction where that is the main reason for admission will be excluded.
- •The patients whose assessed musical preferences involve orchestral or other kinds of music which cannot be performed live by voice and a guitar.
结局指标
主要结局
Recruitment rate
时间窗: Up to 52 weeks
How many participants were recruited and randomized per month on average from those eligible, calculated by dividing the total number of the participants recruited by the total number of months that the trial recruited for.
Treatment fidelity rating and internal and external validity of the study
时间窗: Up to 52 weeks
The level of treatment fidelity will be determined using NIH Behavioral Change Consortium questionnaire which assesses 5 mutually exclusive categories: study design, training, delivery, receipt, and enactment. The tool lists 25 fidelity attributes that should be rated dichotomously as:" Present", "Absent but should be present", or "Not applicable".
Retention and attrition rates
时间窗: Up to 52 weeks
Retention is defined as trial completion on study intervention, and will be calculated by dividing the number of participants completing the study by the total number of participants recruited. Attrition rates will be estimated by the percentage of participants that withdrew from the study, and calculated by dividing the number of the participants who withdrew by the total number recruited.
Adherence and deviations rates
时间窗: Up to 52 weeks
Adherence to the study protocol is defined as compliance with the described study protocol, and protocol deviations as any change or divergence from the study protocol for each participant. Adherence rate will be estimated by calculating the percentage of the music sessions (interventions) actually completed from those described in the protocol (by dividing the number of completed sessions by the number of planned sessions), and deviation rates will be measured by counting the deviations per participant during their participation in the study.
次要结局
- Delirium severity(Up to 7 days)
- Cognitive status(Up to 7 days.)
- Length of hospital stay(Up to 3 weeks.)
- Use of "rescue medication" during hospital stay(Up to 3 weeks.)
- Duration of delirium during hospital stay(Up to 3 weeks.)
研究者
Bjørn Erik Neerland, MD
Principal Investigator, MD, PhD
Oslo University Hospital