Does Perioperative Music Prevent Sleep Disturbances in Hospitalized Surgical Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- Subjective sleep quality assessed using a questionnaire
研究概览
简要总结
Sleep disturbances are known to be a prevalent problem in hospitalized, surgical patients, which is of importance since sleep disturbances can lead to a range of negative health outcomes. Music interventions have shown potential in improving sleep quality. Unfortunately, the studies on the effect of music on sleep in surgical patient populations are still scarce and of low quality. Therefore, the aim of this study is to study the effect of music on sleep quality in oncological, gastro-intestinal surgical patients in the form of a randomized controlled trial. Participants will be divided in 2 groups, a music group and a control group, where the music group will receive music interventions perioperatively. The researchers will compare both groups to see if there is a difference in sleep quality.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 years or older
- •Patients undergoing major elective abdominal surgery for malignant disease, including, but not limited to: Esophageal, gastric, colorectal, hepatic, pancreatic, gynecological and urological surgical procedures.
- •Sufficient knowledge of the Dutch language.
- •Communicable and able to assess the questionnaires
- •Written informed consent acquired from the patient.
排除标准
- •Patients with severe hearing impairment (defined as no or barely verbal communication possible).
- •The patient is expected to be transferred to another hospital postoperatively.
- •Participation in another study that may possibly intervene with the outcome measures. (e.g. in trial use of sleep medication, interventions regarding sleep quality or quantity or similar procedures)
- •Assessment of primary outcome is not possible.
- •Inability or unwillingness to receive the music intervention.
- •Inability to wear the actigraphy device, or inability to perform actigraphy measurement due to paralysis.
结局指标
主要结局
Subjective sleep quality assessed using a questionnaire
时间窗: On the morning of day 2, 3 and 4 at the surgical ward
Using the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep disturbance questionnaire, raw summary score
次要结局
- Objective sleep assessment(During the (possible) intervention period, until day 5 postoperatively)
- Anxiety(Every morning during the (possible) intervention period, until day 5 postoperatively)
- Subjective sleep quantity(During the (possible) intervention period, until day 5 postoperatively)
- Music listening during study period(During the (possible) intervention period, until day 5 postoperatively)
- Subclinical stess using(At baseline and at the end of the (possible) intervention period, at day 5 postoperatively)
- Postoperative quality of recovery using a questionnaire(At baseline, at the end of the (possible) intervention period (from start of study until day 5 postoperatively) and 30 days after discharge)
- Patient satisfaction using a self-made questionnaire(At the end of the study period, 30 days after discharge)
- Music preference and importance in daily life(At baseline)
- Delirium incidence(During the entire hospital stay surrounding the surgery, up to day 30 postoperatively.)
- Quality of life score(At baseline, at the end of the (possible) intervention period (from start of study until day 5 postoperatively) and 30 days after discharge)
- Cost consequences and cost-effectiveness(30 days after discharge)
研究者
C. Verhoef
Prof. Dr. C. Verhoef
Erasmus Medical Center