Effects of Slow and Deep Breathing on Reducing Obstetric Intervention in Women With Pregnancy-induced Hypertension:A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 3
- 主要终点
- Adherence to the breathing exercise intervention
研究概览
简要总结
This study evaluates the effect of slow and deep breathing on lowering blood pressure in women with pregnancy-induced hypertension. Slow and deep breathing will be practised daily for 10 minutes from enrolment until the woman gives birth. This feasibility study aims to investigate the practicality of conducting a proposed future randomised controlled trial.
详细描述
In addition to the slow and deep breathing intervention the women will undertake a short protocol investigating the physiological responses to slow and deep breathing during their initial meeting. The women will undertake 4 separate 5-min breathing exercises with a 5 minute rest period between each exercise. The breathing exercises are normal breathing, and fixed breathing frequencies of 4, 6 and 8 breaths per minute. Blood pressure, heart rate and breathing rate will be monitored continuously, and non-invasively, throughout each breathing protocol.
The women will also have the opportunity to provide feedback on the intervention and their experiences in an online survey at 36 weeks gestation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Diagnosed with pregnancy-induced hypertension (PIH). Defined as "new hypertension presenting after 20 weeks of pregnancy without significant proteinuria (urinary protein:creatinine ratio greater than 30mg/mmol" by NICE guidelines (2010) OR diagnosed as having one-off high blood pressure but at risk of developing PIH;
- •Single pregnancy;
- •Capable of giving informed consent;
- •Age over 18.
排除标准
- •Under 18 years old;
- •Referred immediately to obstetric-care after PIH diagnosis for an immediate intervention, with systolic blood pressure over 160 mmHg or diastolic blood pressure over 100 mmHg;
- •Multiple pregnancy (twins, triplets, etc.);
- •Current smoker;
- •Current diagnosis of respiratory diseases; asthma, COPD (Chronic Obstructive Pulmonary disease), bronchitis. (A previous occurrence or diagnosis that has not been present for longer than 1 year ago does not exclude participants, i.e. childhood asthma);
- •Allergy/reaction to gel used on ECG tabs;
- •Vulnerable participants who are unable to give informed consent.
结局指标
主要结局
Adherence to the breathing exercise intervention
时间窗: Up to 22 weeks (From enrolment to giving birth)
Proportion of days breathing exercise completed per participant and average proportion of days breathing exercise completed
次要结局
- Proportion of women referred to obstetric-led care(Up to 22 weeks (From enrolment to giving birth))