Alternate Nostril Breathing (ANB) for 1st Trimester Nausea and Vomiting
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Severity of Nausea and Vomiting
研究概览
简要总结
This is a prospective, two-arm, non-blinded randomized controlled study designed to evaluate the effects of a one-week alternate nostril breathing (ANB) intervention on nausea and vomiting severity in pregnant individuals during their first trimester.
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
- None
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
- •Pregnant individuals aged 18 years or older
- •Viable pregnancy with a gestational age between 6 0/7 - 12 6/7 weeks of gestation, confirmed by last menstrual period or ultrasound
- •Diagnosed with mild to moderate NVP (PUQE-24 score between 4-12)
- •Ability to understand and read English
排除标准
- •Severe nausea and vomiting, defined as a PUQE score >12, or diagnosis of hyperemesis gravidarum requiring hospitalization or intravenous fluid therapy
- •Pre-existing, active or acute respiratory conditions (e.g., asthma, COPD)
- •History of severe anxiety disorders affecting breathing patterns
- •Known deviated nasal septum
- •Nausea and vomiting that pre-dates the pregnancy or is suspected to be due to a etiology other than pregnancy
研究组 & 干预措施
Alternate Nostril Breathing
Participants in the intervention group will receive a brief orientation via a research team member at the time of randomization on alternate nostril breathing (ANB) and then be provided with a written and video-based instructional guide. They will be instructed to perform ANB 3 times per day for 5-10 minutes per session over a 7-day period and document their sessions in a daily symptom diary. The 7-day period will begin the following day after enrollment to allow for a full day of intervention implementation (Day 1-7).
干预措施: Alternate Nostril Breathing (Behavioral)
Usual Care Only
This group will receive usual care and complete a daily symptom diary for Day 1-7.
结局指标
主要结局
Severity of Nausea and Vomiting
时间窗: Day 7
Measured by the change in the Pregnancy-Unique Quantification of Emesis and Nausea (PUQE) score, where scores range from 3-15, and a higher score indicates greater severity of nausea and vomiting.
次要结局
未报告次要终点
