Comparison of Musicotherapy Sessions Using Patient Play-list Versus U Sequence Music Care Medical Device on Pre-operative Anxiety in Women Undergoing Gynecological Surgery: a Randomized-control Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 170
- 试验地点
- 2
- 主要终点
- Situation anxiety measurement
研究概览
简要总结
Anxiety is a psychologic and physiological state that could be characterized by somatic, emotional, cognitive and behavioral components. Surgery, as well as waiting for surgery is an anxiogenic situation encountered by 60 à 80 % of the patients. High levels of anxiety lead to negative physiological signs that slow down healing, lowers imune response and increases post-surgery infection. Anxiety also increases pain and post-surgery morbi-mortality. Drug-induced sedation is frequently recommended to lower anxiety. The anxiolytic effect of alternative treatment such as musicotherapy has been demonstrated in several randomized control trials. Nevertheless, most of these studies have investigated the effect of musicotherapy in groups with our without musical listening.
In the present study, investigators assume that a personal musical sequence composed by favourite songs of the patients could have beneficial effect on presurgical anxiety than selective sequence of the medical device MUSIC CARE.
In this study, the anxiolytic effect of predefined U musical sequences that alternate slow and faster music tracks (medical device MUSIC CARE) are compared to patient's play-list, in women with planned gynecological surgery.
详细描述
Patients are randomly allocated in two groups:
- control group: patients are asked to choose one of the U sequence among the preselected music style proposed by the medical device MUSIC CARE
- test group: patients are asked to prepare their own play-list containing their favourite songs
Anxiety is assessed before and after a 20 min-musicotherapy session by using the State-Trait Anxiety Inventory (STAI) for anxiogenic situation.
Other parameters are measured such as blood pressure, cardiac frequency, level of pain after surgery, care stay duration, potent post-surgery complications.
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
- Double (Care Provider, Investigator)
盲法说明
blindness concerns medical staff: nurses in charge of the blood parameters measurements as well as anxiety evaluation are not informed of the allocation of the patients
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •with planed gynecologic surgery
- •without anxiolytic medication
- •able to prepare their own play-list
- •signed inform consent
排除标准
- •hearing disorder
- •dementia or psychiatric disorder
- •neurologic disorder
结局指标
主要结局
Situation anxiety measurement
时间窗: Change from baseline anxiety at 20 minutes musical listening
Pre-operative anxiety is assessed by the STAY-situation questionnaire
次要结局
- Care stay duration(At study completion, an average of 3 days)
- Blood pressure(Change from baseline blood pressure at 20 minutes musical listening)
- Post-operative pain(Up to one hour after surgery recovery)
- Heart rate(Change from baseline heart at 20 minutes musical listening)
- Post-operative complications(Through study completion, an average of 3 days)