Deep Breathing Techniques (Pranayama) in Pregnancy

NCT05341921 | Completed

• 1 other identifier: STUDY00002180
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Related; Hypertension in Pregnancy; Blood Pressure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change of heart rate from baseline to after the intervention

  One visit, 15 minute intervention

• Change in body temperature from baseline to after the intervention

  One visit, 15 minute intervention

• Change in cardiac output from baseline to after the intervention

  One visit, 15 minute intervention

Study Arms (6)

Alternate Nostril Breathing Phase I

ACTIVE COMPARATOR

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

Behavioral: Alternate Nostril Breathing

Bhramari Breathing Phase I

ACTIVE COMPARATOR

Bhramari breathing for normotensive women in 3rd trimester of pregnancy

Behavioral: Bhramari Breathing

Sheetali Breathing Phase I

ACTIVE COMPARATOR

Sheetali breathing for normotensive women in 3rd trimester of pregnancy

Behavioral: Sheetali Breathing

Alternate Nostril Breathing Phase II

ACTIVE COMPARATOR

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

Behavioral: Alternate Nostril Breathing

Bhramari Breathing Phase II

ACTIVE COMPARATOR

Bhramari breathing for hypertensive women in 3rd trimester of pregnancy

Behavioral: Bhramari Breathing

Sheetali Breathing Phase II

ACTIVE COMPARATOR

Sheetali breathing for hypertensive women in 3rd trimester of pregnancy

Behavioral: Sheetali Breathing

Interventions

Alternate Nostril Breathing BEHAVIORAL

Utilizing Pranayama (deep breathing technique) in normotensive and hypertensive women in 3rd trimester of pregnancy

Alternate Nostril Breathing Phase I; Alternate Nostril Breathing Phase II

Bhramari Breathing BEHAVIORAL

Utilizing Pranayama (deep breathing technique) in normotensive and hypertensive women in 3rd trimester of pregnancy

Bhramari Breathing Phase I; Bhramari Breathing Phase II

Sheetali Breathing BEHAVIORAL

Utilizing Pranayama (deep breathing technique) in normotensive and hypertensive women in 3rd trimester of pregnancy

Sheetali Breathing Phase I; Sheetali Breathing Phase II

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead

Study Sites (1)

Advent Health Shawnee Mission Birth Center

Merriam, Kansas, 66204, United States

Location

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Shilpa Babbar, MD

  Children's Mercy Hospital Kansas City

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot, randomized, controlled trial

Study Record Dates

• First Submitted: April 18, 2022
• First Posted: April 22, 2022
• Study Start: August 2, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 20, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)