NCT03194191Unknown不适用
Pregnancy With Insomnia: a Trial of Acupuncture
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 主要终点
- Insomnia severity index (ISI)
研究概览
简要总结
Acupuncture is widely used for treatment of insomnia. The research hypothesis is that acupuncture may be more effective than sham acupuncture to treat insomnia during pregnancy.
GAS is a randomized controlled trial with placebo acupuncture using the insomnia severity index (ISI) as the main outcome criterion.
详细描述
Scientific justification:
- During pregnancy, insomnia occurs mainly in women without a previous history of sleep disorder, and may remain after delivery. Insomnia affects the quality of life. It might be associated with an increase in labor duration and cesarean section rate.
Insomnia tends to worsen during gestation, owing to back pain, an increased need to micturate, and the movement of the fetus. Sleep disorders are often associated with restless legs syndrome.
- To treat insomnia during pregnancy, the Haute Autorité de Santé (HAS) recommends avoiding using psychotropic medications. It also recommends screening for depression or anxiety traits often associated with insomnia. However, in most cases, psychological means alone fail to treat insomnia effectively.
- Based on 11 randomized controlled trials, the odds of improving sleep disorders are 3 times greater with than without acupuncture, but the methodological quality of these trials is considered insufficient to conclude.
Population:
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 (Participant)
盲法说明
Single blind (patient blinded to intervention)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Singleton pregnancy
- •Gestational age ≥ 16 weeks + 0 day and ≤ 32 weeks + 6 days
- •Insomnia Severity Index ≥ 10
- •Insomnia reported to have started during pregnancy and at least 2 weeks before inclusion
- •Patient understanding the study
- •Informed consent signed
- •Social insurance available at inclusion and until the end of pregnancy
排除标准
- •Threatened premature labor
- •Small fetus for gestational age
- •Pre-eclampsia
- •Insomnia starting before pregnancy
- •Use of psychotropic drugs before pregnancy
- •Use of recreational drugs during pregnancy
- •Known psychiatric disorder
- •Anticoagulant therapy
- •Patient reporting insomnia results from chronic or acute pain
- •Obstructive sleep apnea (OSA) requiring treatment
- •Patient under antidepressant therapy
- •Patient under legal guardianship or deprived of freedom
结局指标
主要结局
Insomnia severity index (ISI)
时间窗: Inclusion visit and 5 weeks after the first acupuncture session
Difference of ISI self-report questionnaire administrated at inclusion visit and 5 weeks after the first acupuncture session
次要结局
- Perinatal outcome - sex(At birth)
- Pittsburgh Sleep Quality Index (PSQI)(Inclusion visit and 5 weeks after the first acupuncture session)
- Cumulated dose of tobacco(Inclusion visit and 5 weeks after the first acupuncture session)
- Perinatal outcome - Gestational age at birth(At birth)
- Perinatal outcome - birth weight(At birth)
- Perinatal outcome - perinatal mortality(At birth)
- Perinatal outcome - five minutes Apgar score(At birth)
- Hospital Anxiety and Depression Scale (HADS)(Inclusion visit and 5 weeks after the first acupuncture session)
- Perinatal outcome - birth height(At birth)
- Perinatal outcome - cesarean section rate(At birth.)
- Cumulated dose of each psychotropic medicine(Inclusion visit and 5 weeks after the first acupuncture session)
- Cumulated dose of alcohol(Inclusion visit and 5 weeks after the first acupuncture session)
- Cumulated dose of cannabis(Inclusion visit and 5 weeks after the first acupuncture session)
- Difference in the frequency of restless leg syndrome(Inclusion visit and 5 weeks after the first acupuncture session)
- Cumulated dose of other recreational substances or medicine(Inclusion visit and 5 weeks after the first acupuncture session)
研究者
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