A Randomized Controlled Trial of The Effectiveness of Guided Imagery on Blood Pressure in Hypertensive Pregnant Women: The Relaxation and Blood Pressure in Pregnancy (REBIP) Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 4
- 主要终点
- Daytime ambulatory mean arterial pressure
研究概览
简要总结
Over 10% of women have high blood pressure during their pregnancy which may affect their health or that of their baby. There are currently no methods to prevent most high blood pressure in pregnancy and some treatments are not desirable for use in pregnancy. Previous research indicates that simple relaxation methods can reduce blood pressure and anxiety levels for some people, but this has not been well-studied, especially during pregnancy. This pilot study is intended to determine how guided imagery (imagining relaxing scenes) affects blood pressure and anxiety, and to assess how satisfied women are with this technique. Sixty-six pregnant women with high blood pressure will be randomly assigned to (1) listen to a guided imagery audio-compact disc or (2) quiet rest, at least twice-daily for 4 weeks. All women in both groups will receive all usual care, plus will have their blood pressure measured regularly during 1 day per week for 4 weeks. This study will determine if imagery lowers maternal blood pressure, and if further research on imagery effects on pregnancy health outcomes is feasible.
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant, and less than or equal to (<) 36 weeks, 6 days gestation
- •At least two prenatal blood pressure readings > 90 mmHg diastolic
- •Has had clinical investigation of the hypertension
- •Hearing acuity adequate to hear verbal and audiotaped instructions
- •Planning to give birth at one of the study site health centres
- •Competent to give informed consent
排除标准
- •Likely to deliver within 10 days (including women with diastolic BP >110 mmHg, or systolic BP >170 mmHg; unstable diabetes, concurrent antepartum hemorrhage, preterm labour, and/or other significant medical)
- •Prescribed antihypertensive medication at baseline
- •Documented psychotic illness
- •Unable to understand and read English
结局指标
主要结局
Daytime ambulatory mean arterial pressure
时间窗: 4 weeks post-randomization (or if delivery is sooner, at most recent ambulatory BP monitoring session
次要结局
- Daytime ambulatory systolic and diastolic blood pressure, and heart rate(4 weeks post-randomization (or if delivery is sooner, at most recent ambulatory BP monitoring session)
- Antihypertensive medication use after randomization(between randomization and end of postpartum hospitalization)
- Maternal anxiety(4 weeks post-randomization (or if delivery is sooner, at most recent week of available data.)
- Time to delivery
- Relationship of blood pressure changes to reported frequency of guided imagery undertaken
- Relationship between classification of hypertension and effectiveness of guided imagery
- Relationship between participants' evaluations of their imagery experiences and effectiveness of guided imagery(At 4 weeks post-randomization (or if delivery is sooner, at most recent week od available data))