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Deep Breathing Techniques (Pranayama) in Pregnancy

Primary Purpose

Pregnancy Related, Hypertension in Pregnancy, Blood Pressure

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Alternate Nostril Breathing
Bhramari Breathing
Sheetali Breathing
Sponsored by
Children's Mercy Hospital Kansas City
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pregnancy Related

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

- Any pregnant woman in the 3rd trimester after 28 weeks of pregnancy who is/has

  • 18 years of age or older
  • English speaking
  • Phase II Only- Chronic hypertension - defined as pre-existing elevated blood pressure prior to pregnancy or less than 20 weeks gestation (Systolic blood pressure greater than or equal to 140 mmHg and /or a diastolic blood pressure greater than or equal to 90 mmHg) with or without antihypertensive use
  • Phase II Only- Gestational hypertension - defined as elevated blood pressure (Systolic blood pressure greater than or equal to 140 mmHg and /or a diastolic blood pressure greater than or equal to 90 mmHg) after 20 weeks of pregnancy without any evidence of end-organ damage or proteinuria, with or without antihypertensive use
  • Phase II Only- Preeclampsia without severe features - defined as elevated blood pressure (Systolic blood pressure greater than or equal to 140 mmHg but less than 160 mmHG and /or a diastolic blood pressure greater than or equal to 90 mmHg but less than 110 mmHg on two or more occasions 4 hours or more apart) with evidence of proteinuria, with or without antihypertensive use

Exclusion Criteria:

  • Any unstable maternal or fetal condition that requires urgent delivery
  • Any concerns for pre-eclampsia with or without severe features (i.e. Development of HELLP syndrome or eclampsia)
  • Severe pulmonary disease
  • Active or acute pulmonary disease
  • Known deviated nasal septum
  • Does not desire to perform breath-controlled exercises
  • Low blood pressure defined as baseline blood pressure less or equal to a systolic of 90 mmHg and/or a diastolic blood pressure of 60 mmHg
  • Cannot roll their tongue
  • Have difficulty or cannot breathe through their nose

Sites / Locations

  • Advent Health Shawnee Mission Birth CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Alternate Nostril Breathing Phase I

Bhramari Breathing Phase I

Sheetali Breathing Phase I

Alternate Nostril Breathing Phase II

Bhramari Breathing Phase II

Sheetali Breathing Phase II

Arm Description

Alternate nostril breathing for normotensive women in 3rd trimester of pregnancy

Bhramari breathing for normotensive women in 3rd trimester of pregnancy

Sheetali breathing for normotensive women in 3rd trimester of pregnancy

Alternate nostril breathing for hypertensive women in 3rd trimester of pregnancy

Bhramari breathing for hypertensive women in 3rd trimester of pregnancy

Sheetali breathing for hypertensive women in 3rd trimester of pregnancy

Outcomes

Primary Outcome Measures

Change of blood pressure from baseline in normotensive and hypertensive women in 3rd trimester pregnancy while utilizing various pranayama breathing techniques
Continuous blood pressure monitored while participants engage in a deep breathing technique (pranayama breathing)

Secondary Outcome Measures

Change of heart rate from baseline to after the intervention
Continuous heart rate monitor will be applied
Change in body temperature from baseline to after the intervention
Continuous temperature monitor will be applied
Change in cardiac output from baseline to after the intervention
Continuous cardiac output monitor will be applied

Full Information

First Posted
April 18, 2022
Last Updated
September 11, 2023
Sponsor
Children's Mercy Hospital Kansas City
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1. Study Identification

Unique Protocol Identification Number
NCT05341921
Brief Title
Deep Breathing Techniques (Pranayama) in Pregnancy
Official Title
The Acute Effects of Pranayama (Deep Breathing Techniques) on Physiological Parameters in Pregnancy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 2, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Mercy Hospital Kansas City

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Slow deep breathing actives the vagal nerve and leads to a natural reduction in physiological parameters such as blood pressure, heart rate and digestion. The effects of these techniques have not been assessed in pregnancy. The primary objective is to assess the effects of various yogic deep breathing techniques on blood pressure during pregnancy. The breathing exercises will include Alternate nostril breathing, Bhramari breathing, and Sheetali breathing. A secondary objective will be to assess the effects of these breathing exercises on other physiological parameters including heart rate, heart rate variability, body temperature, cardiac output, vascular resistance and respiratory rate.
Detailed Description
The trial will be conducted as a pilot study in one study visit, which will be conducted in two phases. Phase I will be conducted on normotensive pregnant women and Phase II will be conducted on hypertensive pregnant women. Participants will be in their third trimester of pregnancy (28 weeks onwards). Upon presentation, they will be randomized into one of three groups: Alternate nostril breathing, Bhramari breathing or Sheetali breathing. Maternal monitoring devices will be placed on the patient before the intervention. The fetus will be monitored by external monitors consisting of a fetal heart rate monitor and tocodynamometer to assess uterine activity. Fetal position will be assessed before and after the intervention by ultrasound. All devices will obtain a reading for 15 minutes before, during and after the intervention. Intervention: In an upright, seated position, the participant will engage in a total of 15 minutes of one deep breathing technique. The breathing practice will be conducted in three, 5-minute increments with a one-minute break between each session. These breathing techniques are easy to learn and participants will be taught how to perform the exercise (visual demonstration, verbal and written instructions will be provided). Participants will be given the opportunity to practice the breathing technique and ask any questions prior to initiating monitoring.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Related, Hypertension in Pregnancy, Blood Pressure

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Pilot, randomized, controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Alternate Nostril Breathing Phase I
Arm Type
Active Comparator
Arm Description
Alternate nostril breathing for normotensive women in 3rd trimester of pregnancy
Arm Title
Bhramari Breathing Phase I
Arm Type
Active Comparator
Arm Description
Bhramari breathing for normotensive women in 3rd trimester of pregnancy
Arm Title
Sheetali Breathing Phase I
Arm Type
Active Comparator
Arm Description
Sheetali breathing for normotensive women in 3rd trimester of pregnancy
Arm Title
Alternate Nostril Breathing Phase II
Arm Type
Active Comparator
Arm Description
Alternate nostril breathing for hypertensive women in 3rd trimester of pregnancy
Arm Title
Bhramari Breathing Phase II
Arm Type
Active Comparator
Arm Description
Bhramari breathing for hypertensive women in 3rd trimester of pregnancy
Arm Title
Sheetali Breathing Phase II
Arm Type
Active Comparator
Arm Description
Sheetali breathing for hypertensive women in 3rd trimester of pregnancy
Intervention Type
Behavioral
Intervention Name(s)
Alternate Nostril Breathing
Intervention Description
Utilizing Pranayama (deep breathing technique) in normotensive and hypertensive women in 3rd trimester of pregnancy
Intervention Type
Behavioral
Intervention Name(s)
Bhramari Breathing
Intervention Description
Utilizing Pranayama (deep breathing technique) in normotensive and hypertensive women in 3rd trimester of pregnancy
Intervention Type
Behavioral
Intervention Name(s)
Sheetali Breathing
Intervention Description
Utilizing Pranayama (deep breathing technique) in normotensive and hypertensive women in 3rd trimester of pregnancy
Primary Outcome Measure Information:
Title
Change of blood pressure from baseline in normotensive and hypertensive women in 3rd trimester pregnancy while utilizing various pranayama breathing techniques
Description
Continuous blood pressure monitored while participants engage in a deep breathing technique (pranayama breathing)
Time Frame
One visit, 15 minute intervention
Secondary Outcome Measure Information:
Title
Change of heart rate from baseline to after the intervention
Description
Continuous heart rate monitor will be applied
Time Frame
One visit, 15 minute intervention
Title
Change in body temperature from baseline to after the intervention
Description
Continuous temperature monitor will be applied
Time Frame
One visit, 15 minute intervention
Title
Change in cardiac output from baseline to after the intervention
Description
Continuous cardiac output monitor will be applied
Time Frame
One visit, 15 minute intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: - Any pregnant woman in the 3rd trimester after 28 weeks of pregnancy who is/has 18 years of age or older English speaking Phase II Only- Chronic hypertension - defined as pre-existing elevated blood pressure prior to pregnancy or less than 20 weeks gestation (Systolic blood pressure greater than or equal to 140 mmHg and /or a diastolic blood pressure greater than or equal to 90 mmHg) with or without antihypertensive use Phase II Only- Gestational hypertension - defined as elevated blood pressure (Systolic blood pressure greater than or equal to 140 mmHg and /or a diastolic blood pressure greater than or equal to 90 mmHg) after 20 weeks of pregnancy without any evidence of end-organ damage or proteinuria, with or without antihypertensive use Phase II Only- Preeclampsia without severe features - defined as elevated blood pressure (Systolic blood pressure greater than or equal to 140 mmHg but less than 160 mmHG and /or a diastolic blood pressure greater than or equal to 90 mmHg but less than 110 mmHg on two or more occasions 4 hours or more apart) with evidence of proteinuria, with or without antihypertensive use Exclusion Criteria: Any unstable maternal or fetal condition that requires urgent delivery Any concerns for pre-eclampsia with or without severe features (i.e. Development of HELLP syndrome or eclampsia) Severe pulmonary disease Active or acute pulmonary disease Known deviated nasal septum Does not desire to perform breath-controlled exercises Low blood pressure defined as baseline blood pressure less or equal to a systolic of 90 mmHg and/or a diastolic blood pressure of 60 mmHg Cannot roll their tongue Have difficulty or cannot breathe through their nose
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shilpa Babbar, MD
Phone
816-226-7850
Email
sbabbar1@cmh.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shilpa Babbar, MD
Organizational Affiliation
Children's Mercy Hospital Kansas City
Official's Role
Principal Investigator
Facility Information:
Facility Name
Advent Health Shawnee Mission Birth Center
City
Merriam
State/Province
Kansas
ZIP/Postal Code
66204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shilpa Babbar, MD
Phone
816-226-7850
Email
sbabbar1@cmh.edu

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Undecided at this time.

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Deep Breathing Techniques (Pranayama) in Pregnancy

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