Deep Breathing Techniques (Pranayama) in Pregnancy

Blood Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05341921
• Other study ID #: STUDY00002180
• Status: Recruiting
• Phase: N/A
• Start date: August 2, 2022
• Est. completion date: December 2024

Study information

• Verified date: September 2023
• Source: Children's Mercy Hospital Kansas City
• Contact: Shilpa Babbar, MD
• Phone: 816-226-7850
• Email: sbabbar1[@]cmh.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure
• Hypertension in Pregnancy
• Hypertension, Pregnancy-Induced
• Pregnancy Related

Intervention

Behavioral:
• Alternate Nostril Breathing
Utilizing Pranayama (deep breathing technique) in normotensive and hypertensive women in 3rd trimester of pregnancy
• Bhramari Breathing
Utilizing Pranayama (deep breathing technique) in normotensive and hypertensive women in 3rd trimester of pregnancy
• Sheetali Breathing
Utilizing Pranayama (deep breathing technique) in normotensive and hypertensive women in 3rd trimester of pregnancy

Locations

Country	Name	City	State
United States	Advent Health Shawnee Mission Birth Center	Merriam	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change of heart rate from baseline to after the intervention	Continuous heart rate monitor will be applied	One visit, 15 minute intervention
Secondary	Change in body temperature from baseline to after the intervention	Continuous temperature monitor will be applied	One visit, 15 minute intervention
Secondary	Change in cardiac output from baseline to after the intervention	Continuous cardiac output monitor will be applied	One visit, 15 minute intervention