Deep Breathing Techniques (Pranayama) in Pregnancy

The Acute Effects of Pranayama (Deep Breathing Techniques) on Physiological Parameters in Pregnancy

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy Related; Blood Pressure; Hypertension in Pregnancy
• Intervention / Treatment: Behavioral: Alternate Nostril Breathing; Behavioral: Bhramari Breathing; Behavioral: Sheetali Breathing

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.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shilpa Babbar, MD; Phone Number: 816-226-7850; Email: sbabbar1@cmh.edu

Study Locations

• United States
  • Kansas
    • Merriam, Kansas, United States, 66204
      • Recruiting
      • Advent Health Shawnee Mission Birth Center
      • Contact: Shilpa Babbar, MD; Phone Number: 816-226-7850; Email: sbabbar1@cmh.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Alternate Nostril Breathing Phase I; Alternate nostril breathing for normotensive women in 3rd trimester of pregnancy	Behavioral: Alternate Nostril Breathing; Utilizing Pranayama (deep breathing technique) in normotensive and hypertensive women in 3rd trimester of pregnancy
Active Comparator: Bhramari Breathing Phase I; Bhramari breathing for normotensive women in 3rd trimester of pregnancy	Behavioral: Bhramari Breathing; Utilizing Pranayama (deep breathing technique) in normotensive and hypertensive women in 3rd trimester of pregnancy
Active Comparator: Sheetali Breathing Phase I; Sheetali breathing for normotensive women in 3rd trimester of pregnancy	Behavioral: Sheetali Breathing; Utilizing Pranayama (deep breathing technique) in normotensive and hypertensive women in 3rd trimester of pregnancy
Active Comparator: Alternate Nostril Breathing Phase II; Alternate nostril breathing for hypertensive women in 3rd trimester of pregnancy	Behavioral: Alternate Nostril Breathing; Utilizing Pranayama (deep breathing technique) in normotensive and hypertensive women in 3rd trimester of pregnancy
Active Comparator: Bhramari Breathing Phase II; Bhramari breathing for hypertensive women in 3rd trimester of pregnancy	Behavioral: Bhramari Breathing; Utilizing Pranayama (deep breathing technique) in normotensive and hypertensive women in 3rd trimester of pregnancy
Active Comparator: Sheetali Breathing Phase II; Sheetali breathing for hypertensive women in 3rd trimester of pregnancy	Behavioral: Sheetali Breathing; Utilizing Pranayama (deep breathing technique) in normotensive and hypertensive women in 3rd trimester of pregnancy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	One visit, 15 minute intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of heart rate from baseline to after the intervention	Continuous heart rate monitor will be applied	One visit, 15 minute intervention
Change in body temperature from baseline to after the intervention	Continuous temperature monitor will be applied	One visit, 15 minute intervention
Change in cardiac output from baseline to after the intervention	Continuous cardiac output monitor will be applied	One visit, 15 minute intervention

Collaborators and Investigators

• Sponsor: Children's Mercy Hospital Kansas City
• Investigators: Principal Investigator: Shilpa Babbar, MD, Children's Mercy Hospital Kansas City

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2022
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: April 18, 2022
• First Submitted That Met QC Criteria: April 21, 2022
• First Posted (Actual): April 22, 2022

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 11, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Pregnancy Complications; Hypertension; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension, Pregnancy-Induced
• Other Study ID Numbers: STUDY00002180

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Undecided at this time.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No