- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07378839
Alternate Nostril Breathing (ANB) for 1st Trimester Nausea and Vomiting
March 16, 2026 updated by: University of Minnesota
This is a prospective, two-arm, non-blinded randomized controlled study designed to evaluate the effects of a one-week alternate nostril breathing (ANB) intervention on nausea and vomiting severity in pregnant individuals during their first trimester.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Erin Wesley
- Phone Number: 612-624-9208
- Email: obgynresearch@umn.edu
Study Locations
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55455
- Recruiting
- University of Minnesota
-
Contact:
- Erin Wesley
- Phone Number: 612-624-9208
- Email: obgynresearch@umn.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Pregnant individuals aged 18 years or older
- Viable pregnancy with a gestational age between 6 0/7 - 12 6/7 weeks of gestation, confirmed by last menstrual period or ultrasound
- Diagnosed with mild to moderate NVP (PUQE-24 score between 4-12)
- Ability to understand and read English
Exclusion Criteria:
- Severe nausea and vomiting, defined as a PUQE score >12, or diagnosis of hyperemesis gravidarum requiring hospitalization or intravenous fluid therapy
- Pre-existing, active or acute respiratory conditions (e.g., asthma, COPD)
- History of severe anxiety disorders affecting breathing patterns
- Known deviated nasal septum
- Nausea and vomiting that pre-dates the pregnancy or is suspected to be due to a etiology other than pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Alternate Nostril Breathing
Participants in the intervention group will receive a brief orientation via a research team member at the time of randomization on alternate nostril breathing (ANB) and then be provided with a written and video-based instructional guide.
They will be instructed to perform ANB 3 times per day for 5-10 minutes per session over a 7-day period and document their sessions in a daily symptom diary.
The 7-day period will begin the following day after enrollment to allow for a full day of intervention implementation (Day 1-7).
|
ANB 3 times per day for 5-10 minutes per session over a 7-day period
|
|
No Intervention: Usual Care Only
This group will receive usual care and complete a daily symptom diary for Day 1-7.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Severity of Nausea and Vomiting
Time Frame: Day 7
|
Measured by the change in the Pregnancy-Unique Quantification of Emesis and Nausea (PUQE) score, where scores range from 3-15, and a higher score indicates greater severity of nausea and vomiting.
|
Day 7
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Shilpa Babbar, University of Minnesota
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 10, 2026
Primary Completion (Estimated)
March 31, 2027
Study Completion (Estimated)
March 31, 2027
Study Registration Dates
First Submitted
January 23, 2026
First Submitted That Met QC Criteria
January 23, 2026
First Posted (Actual)
January 30, 2026
Study Record Updates
Last Update Posted (Actual)
March 19, 2026
Last Update Submitted That Met QC Criteria
March 16, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OBGYN-2025-34216
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Nausea
-
Hafiz Muhammad HamzaFederal Government Polyclinic (Postgraduate Medical Institute)CompletedPostoperative Nausea and Vomiting (PONV)Pakistan
-
University of North Carolina, Chapel HillNational Institute of Dental and Craniofacial Research (NIDCR)CompletedPost-operative Nausea | Post-operative Vomiting | Nausea PersistentUnited States
-
Cukurova UniversityTarsus UniversityCompletedNausea, Postoperative | Vomiting, Postoperative | APFEL RİSK SCORETurkey
-
MonoSol RxCompletedNausea With Vomiting Chemotherapy-Induced | Nausea and Vomiting, PostoperativeIndia
-
GlaxoSmithKlineCompletedPostoperative Nausea and Vomiting | Nausea and Vomiting, PostoperativeUnited States, Spain, Philippines, Israel, Hong Kong, Thailand, United Kingdom, Hungary, Slovenia, Norway, Denmark
-
Lancaster General HospitalCompletedBariatric Surgery Candidate | Nausea, PostoperativeUnited States
-
Benaroya Research InstituteVirginia Mason Hospital/Medical CenterRecruitingPost Operative Nausea and VomitingUnited States
-
Hoffmann-La RocheCompletedPost-Operative Nausea and VomitingUnited States
-
Cairo UniversityUnknownPost Operative Nausea and VomitingEgypt
-
Yonsei UniversityCompletedPost Operative Nausea and VomitingKorea, Republic of
Clinical Trials on Alternate Nostril Breathing
-
Children's Mercy Hospital Kansas CityCompletedPregnancy Related | Blood Pressure | Hypertension in PregnancyUnited States
-
Foundation University IslamabadRecruiting
-
Temple UniversityCompletedOcular Hypertension
-
Sialkott College of Physical TherapyCompleted
-
Riphah International UniversityCompleted
-
Riphah International UniversityRecruiting
-
Chang Bing Show Chwan Memorial HospitalUnknown
-
Riphah International UniversityCompleted
-
Foundation University IslamabadRecruiting
-
Riphah International UniversityCompletedPost-cardiac SurgeryPakistan