Deep Breathing Techniques (Pranayama) in Pregnancy

NCT ID: NCT05341921

Last Updated: 2025-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-02

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Pregnancy Related Hypertension in Pregnancy Blood Pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Pilot, randomized, controlled trial
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Alternate Nostril Breathing Phase I

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

Group Type ACTIVE_COMPARATOR

Alternate Nostril Breathing

Intervention Type BEHAVIORAL

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

Bhramari Breathing Phase I

Bhramari breathing for normotensive women in 3rd trimester of pregnancy

Group Type ACTIVE_COMPARATOR

Bhramari Breathing

Intervention Type BEHAVIORAL

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

Sheetali Breathing Phase I

Sheetali breathing for normotensive women in 3rd trimester of pregnancy

Group Type ACTIVE_COMPARATOR

Sheetali Breathing

Intervention Type BEHAVIORAL

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

Alternate Nostril Breathing Phase II

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

Group Type ACTIVE_COMPARATOR

Alternate Nostril Breathing

Intervention Type BEHAVIORAL

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

Bhramari Breathing Phase II

Bhramari breathing for hypertensive women in 3rd trimester of pregnancy

Group Type ACTIVE_COMPARATOR

Bhramari Breathing

Intervention Type BEHAVIORAL

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

Sheetali Breathing Phase II

Sheetali breathing for hypertensive women in 3rd trimester of pregnancy

Group Type ACTIVE_COMPARATOR

Sheetali Breathing

Intervention Type BEHAVIORAL

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

Interventions

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Alternate Nostril Breathing

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

Intervention Type BEHAVIORAL

Bhramari Breathing

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

Intervention Type BEHAVIORAL

Sheetali Breathing

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Children's Mercy Hospital Kansas City

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shilpa Babbar, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Mercy Hospital Kansas City

Locations

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Advent Health Shawnee Mission Birth Center

Merriam, Kansas, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY00002180

Identifier Type: -

Identifier Source: org_study_id

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