Pregnancy RelatedNCT05341921
Deep Breathing Techniques (Pranayama) in Pregnancy
A study testing Alternate Nostril Breathing, Bhramari Breathing and Sheetali Breathing in people with Pregnancy Related and Hypertension in Pregnancy, run by Children's Mercy Hospital Kansas City at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Hypertension in Pregnancy, Blood Pressure
- What is being tested?
- Alternate Nostril Breathing, Bhramari Breathing and Sheetali Breathing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Aug 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Advent Health Shawnee Mission Birth Center
Merriam, Kansas, 66204
About this study
Official title: 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.
Read the 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.
- Conditions
- Pregnancy Related, Hypertension in Pregnancy, Blood Pressure
- Being tested
- Alternate Nostril Breathing, Bhramari Breathing, Sheetali Breathing
- Medical subject headings
- Hypertension, Pregnancy-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alternate Nostril BreathingBehavioural
Utilizing Pranayama (deep breathing technique) in normotensive and hypertensive women in 3rd trimester of pregnancy
Bhramari BreathingBehavioural
Utilizing Pranayama (deep breathing technique) in normotensive and hypertensive women in 3rd trimester of pregnancy
Sheetali BreathingBehavioural
Utilizing Pranayama (deep breathing technique) in normotensive and hypertensive women in 3rd trimester of pregnancy
| Study group | Role | What they receive |
|---|---|---|
| Alternate Nostril Breathing Phase I | Active comparator | Alternate nostril breathing for normotensive women in 3rd trimester of pregnancy Receives: Behavioral: Alternate Nostril Breathing |
| Bhramari Breathing Phase I | Active comparator | Bhramari breathing for normotensive women in 3rd trimester of pregnancy Receives: Behavioral: Bhramari Breathing |
| Sheetali Breathing Phase I | Active comparator | Sheetali breathing for normotensive women in 3rd trimester of pregnancy Receives: Behavioral: Sheetali Breathing |
| Alternate Nostril Breathing Phase II | Active comparator | Alternate nostril breathing for hypertensive women in 3rd trimester of pregnancy Receives: Behavioral: Alternate Nostril Breathing |
| Bhramari Breathing Phase II | Active comparator | Bhramari breathing for hypertensive women in 3rd trimester of pregnancy Receives: Behavioral: Bhramari Breathing |
| Sheetali Breathing Phase II | Active comparator | Sheetali breathing for hypertensive women in 3rd trimester of pregnancy Receives: Behavioral: Sheetali Breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: One visit, 15 minute intervention
Secondary outcomes (3)
Change of heart rate from baseline to after the intervention
Continuous heart rate monitor will be applied
Measured: One visit, 15 minute intervention
Change in body temperature from baseline to after the intervention
Continuous temperature monitor will be applied
Measured: One visit, 15 minute intervention
Change in cardiac output from baseline to after the intervention
Continuous cardiac output monitor will be applied
Measured: One visit, 15 minute intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start2 Aug 2022
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot, randomized, controlled trial
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shilpa Babbar, MD, Principal investigator, Children's Mercy Hospital Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05341921
- Sponsor's protocol ID
- STUDY00002180
- Status last verified
- Apr 2025
- First submitted
- 18 Apr 2022
- Last updated
- 20 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Effects of Pranayama (Deep Breathing Techniques) on Physiological Parameters in Pregnancy
- ClinicalTrials.gov ID
- NCT05341921
- Acronym / sponsor ID
- STUDY00002180
- Conditions
- Pregnancy Related, Hypertension in Pregnancy, Blood Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Study start
- 2 Aug 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 22 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Pilot, randomized, controlled trial
| Arm | Type | Receives |
|---|---|---|
| Alternate Nostril Breathing Phase I | Active comparator | Behavioral: Alternate Nostril BreathingAlternate nostril breathing for normotensive women in 3rd trimester of pregnancy |
| Bhramari Breathing Phase I | Active comparator | Behavioral: Bhramari BreathingBhramari breathing for normotensive women in 3rd trimester of pregnancy |
| Sheetali Breathing Phase I | Active comparator | Behavioral: Sheetali BreathingSheetali breathing for normotensive women in 3rd trimester of pregnancy |
| Alternate Nostril Breathing Phase II | Active comparator | Behavioral: Alternate Nostril BreathingAlternate nostril breathing for hypertensive women in 3rd trimester of pregnancy |
| Bhramari Breathing Phase II | Active comparator | Behavioral: Bhramari BreathingBhramari breathing for hypertensive women in 3rd trimester of pregnancy |
| Sheetali Breathing Phase II | Active comparator | Behavioral: Sheetali BreathingSheetali breathing for hypertensive women in 3rd trimester of pregnancy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alternate Nostril BreathingUtilizing Pranayama (deep breathing technique) in normotensive and hypertensive women in 3rd trimester of pregnancy | Behavioural | Alternate Nostril Breathing Phase I, Alternate Nostril Breathing Phase II |
| Bhramari BreathingUtilizing Pranayama (deep breathing technique) in normotensive and hypertensive women in 3rd trimester of pregnancy | Behavioural | Bhramari Breathing Phase I, Bhramari Breathing Phase II |
| Sheetali BreathingUtilizing Pranayama (deep breathing technique) in normotensive and hypertensive women in 3rd trimester of pregnancy | Behavioural | Sheetali Breathing Phase I, Sheetali Breathing Phase II |
Primary outcome
Change of blood pressure from baseline in normotensive and hypertensive women in 3rd trimester pregnancy while utilizing various pranayama breathing techniques
Time frame: One visit, 15 minute intervention
Continuous blood pressure monitored while participants engage in a deep breathing technique (pranayama breathing)
3 secondary outcomes
Change of heart rate from baseline to after the intervention
Time frame: One visit, 15 minute intervention
Change in body temperature from baseline to after the intervention
Time frame: One visit, 15 minute intervention
Change in cardiac output from baseline to after the intervention
Time frame: One visit, 15 minute intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shilpa Babbar, MD principal investigator
Children's Mercy Hospital Kansas City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alternate Nostril Breathing, Bhramari Breathing and Sheetali Breathing in people with Pregnancy Related and Hypertension in Pregnancy, run by Children's Mercy Hospital Kansas City at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of blood pressure from baseline in normotensive and hypertensive women in 3rd trimester pregnancy while utilizing various pranayama breathing techniques (time frame: One visit, 15 minute intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2025.