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Funding and recruitment
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Slow and deep breathing | Experimental | Daily practice of slow and deep breathing for 10 minutes per day. Breathing frequency will be 6 breaths per minute, with participants accessing a video aid to help guide their breathing. Breathing exercises will be conducted from enrolment until birth (maximum ~20 weeks if enrolment at 20 weeks gestation until ~40 weeks gestation birth) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Slow and deep breathing | Other | Please see arm description |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to the breathing exercise intervention | Proportion of days breathing exercise completed per participant and average proportion of days breathing exercise completed | Up to 22 weeks (From enrolment to giving birth) |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of women referred to obstetric-led care | Referral to obstetric-led care will be on the grounds of a test result of 30 mg/mmol^1 in a spot urinary protein, symptom exacerbation and/or increase in systolic and/or diastolic blood pressure | Up to 22 weeks (From enrolment to giving birth) |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of women eligible to participate in study | Proportion of women eligible to participate in the study (using inclusion and exclusion criteria) against number of women who attend the antenatal unit for high blood pressure | 5 months (From start to end of recruitment period) |
| Recruitment rates of participation using a hospital antenatal unit |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Malika Felton | Postgraduate Researcher | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bournemouth University | Bournemouth | BH8 8GP | United Kingdom | |||
| University Hospitals Dorset NHS Foundation Trust |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33463384 | Derived | Felton M, Hundley VA, Grigsby S, McConnell AK. Effects of slow and deep breathing on reducing obstetric intervention in women with pregnancy-induced hypertension: a feasibility study protocol. Hypertens Pregnancy. 2021 Feb;40(1):81-87. doi: 10.1080/10641955.2020.1869250. Epub 2021 Jan 19. |
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| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D006973 | Hypertension |
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All participants will take part in the slow and deep breathing daily exercises.
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Proportion of women participating in the study against number of eligible women who attend the antenatal unit |
| 5 months (From start to end of recruitment period) |
| Proportion of women who would be willing to be randomised in future trials | Proportion of women who would be willing to be randomised in a future trial (asked in post-questionnaire) against those who would not be willing to be randomised | Between gestational age 36 weeks and birth. If participant gives birth prior to 36 weeks they will be invited to participate in the questionnaire when appropriate, but before 36 weeks |
| Adherence to self-monitoring of daily blood pressure | Proportion of days blood pressure recorded per participant and average proportion of days blood pressure recorded | Up to 22 weeks (From enrolment to giving birth) |
| Proportion of women withdrawing | Proportion of women who do not contribute data due to premature delivery, drop-out or worsening high blood pressure | Up to 22 weeks (From enrolment to giving birth) |
| Difference in blood pressure | Average week 1 blood pressure compared with average last week blood pressure (last week prior to giving birth) | Up to 22 weeks (From enrolment to giving birth) |
| Practicality of protocol in delivering slow and deep breathing as an intervention to treat high blood pressure during pregnancy. | Women's perceptions of the intervention, as assessed using the post-questionnaire. The questionnaire includes open ended questions on experiences and barriers to completing the intervention. Likert scale (strongly agree, agree, uncertain, disagree, strongly disagree) questions are also included. | Between gestational age 36 weeks and birth. If participant gives birth prior to 36 weeks they will be invited to participate in the questionnaire when appropriate, but before 36 weeks |
| Heart rate responses to slow and deep breathing | Differences in heart rate between breathing protocols (5 minutes of breathing at 4, 6, and 8 breaths per minute and normal breathing) | Day 1 |
| Blood pressure responses to slow and deep breathing | Differences in blood pressure between breathing protocols (5 minutes of breathing at 4, 6, and 8 breaths per minute and normal breathing) | Day 1 |
| Stroke volume responses to slow and deep breathing | Differences in stroke volume between breathing protocols (5 minutes of breathing at 4, 6, and 8 breaths per minute and normal breathing) | Day 1 |
| Cardiac output responses to slow and deep breathing | Differences in cardiac output between breathing protocols (5 minutes of breathing at 4, 6, and 8 breaths per minute and normal breathing) | Day 1 |
| Poole |
| United Kingdom |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |