Treating Pregnancy Related Insomnia With Music: a Randomised Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Sleep quality
研究概览
简要总结
This study aims to examine the effects of 4 weeks music listening at bedtime on sleep quality during the third trimester of pregnancy.
详细描述
50-60% of pregnant women suffer from insomnia during pregnancy. Pregnancy-related insomnia is often neglected due to a lack of suitable and safe treatments. This study aims to evaluate the effectiveness of music compared to sleep hygiene on sleep quality in a population of first-time pregnant women in the final stages of pregnancy. A post pregnancy follow-up will be completed to test if potential effects of the treatment might last into early motherhood (1-3 months postpartum).
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female, aged 18 years or above, pregnant non-mothers
- •Have a sufficient level of Danish (verbal) to understand and respond to the questions and task instructions
- •Pregnant women will be enrolled in gestation week 29.
排除标准
- •Postnatal depression, i.e. a score of 12 or above on the EPDS questionnaire
- •Comorbid psychiatric disorder (i.e. epilepsy and depression)
- •Using sleep medication
- •Working more than two night shifts per week
- •History of sleep disorders
结局指标
主要结局
Sleep quality
时间窗: Change from baseline to the end of the 4-week intervention, (post-treatment data will be collected immediately after completion of intervention). Furthermore, between group differences at follow up, up to 3 months postpartum
Pittsburgh Sleep Quality Index. Scoring from 0-21 with higher numbers meaning more severe sleep problems. Cut-off score at 5.
Sleep quality - insomnia symptoms
时间窗: Change from baseline to the end of the 4-week intervention, (post-treatment data will be collected immediately after completion of intervention). Furthermore, between group differences at follow up, up to 3 months postpartum
Insomnia Severity Index. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).
次要结局
- Anxiety(Change from baseline to the end of the 4-week intervention, (post-treatment data will be collected immediately after completion of intervention). Furthermore, between group differences at follow up, up to 3 months postpartum)
- Pre-sleep arousal(Change from baseline to the end of the 4-week intervention, (post-treatment data will be collected immediately after completion of intervention). Furthermore, between group differences at follow up, up to 3 months postpartum)
- Stress(Change from baseline to the end of the 4-week intervention, (post-treatment data will be collected immediately after completion of intervention). Furthermore, between group differences at follow up, up to 3 months postpartum)
- Depressive symptoms(Change from baseline to the end of the 4-week intervention, (post-treatment data will be collected immediately after completion of intervention). Furthermore, between group differences at follow up, up to 3 months postpartum)
- Prenatal attachment(Change from baseline to the end of the 4-week intervention, (post-treatment data will be collected immediately after completion of intervention). Furthermore, between group differences at follow up, up to 3 months postpartum)
- Postpartum bonding(Between group differences at follow up, up to 3 months postpartum)
- Childbirth experience(Between group differences at follow up, up to 3 months postpartum)