NCT05808088招募中不适用
The Effect of Hypnotherapeutic Sound-files on the Sleep of Parents in the Neonatal Unit.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Sleep duration
研究概览
简要总结
The goal of this randomised study is to learn about, the effect of hypnotherapeutic sound-files on the sleep of parents of infants in the neonatal unit. The main questions it aims to answer are:
- Can hypnotherapeutic sound-files make parents of infants in the neonatal unit sleep longer and better?
- Does hypnotherapeutic sound-files effect the state anxiety score of parents of infants in the neonatal unit?
Participants will have access to sound-files and:
- wear actigraphy sleep registration
- complete state-trait anxiety score
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 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
- •Parents of a newborn in the neonatal unit at Randers Regional Hospital
排除标准
- •Age under 18
- •Hearing disability to an extend where sound-files cannot be used
- •Psychotic diagnosis, including schizophrenia and personality disorder
- •Already using hypnotherapeutic sound-files
- •The use of sleep medication.
结局指标
主要结局
Sleep duration
时间窗: Actigraphy will be worn 2 weeks
Via actigraphy sleep duration is measured in minutes
Sleep quality
时间窗: Actigraphy will be worn 2 weeks
Sleep quality is data from actigraphy
次要结局
- Trait Anxiety(Trait Anxiety Score are measured at Baseline (inclusion).)
- State Anxiety(State Anxiety score are measured at Baseline ( inclusion), day 7 and day 14)
研究者
研究点 (2)
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