- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07415460
Evaluating the Impact of SKY Breath Meditation on Stress, Well-being, and Connection in College Students (SKY Breath)
Breath of Resilience: Evaluating the Impact of SKY Breath Meditation on Stress, Well-being, and Connection in College Students - A Pilot Feasibility Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The investigators are conducting a small pilot study to explore whether a specific type of breath-based meditation-Sudarshan Kriya Yoga (SKY)-can support the well-being of university students. Over the course of eight weeks, 56 undergraduate and graduate students will be randomly assigned to one of two groups: one group will take part in the SKY program, while the other will follow a general online yoga routine that does not include breathwork.
Participants in the SKY group will begin with a three-day in-person retreat, followed by weekly virtual sessions and independent home practice. The control group will engage in self-paced online yoga and receive occasional check-ins.
The primary focus of this study is feasibility: whether investigators can successfully recruit participants, maintain engagement, and support adherence to the intervention. The study will also examine whether SKY contributes to improvements in participants' physical and mental well-being. In addition to monitoring physical activity, the study will assess changes in perceived stress, anxiety, resilience, social connectedness, and cognitive focus-key areas that commonly affect student populations.
All participants will complete validated mental health and wellness questionnaires before and after the program. Data will be analyzed using statistical methods that include all enrolled participants, regardless of program completion. The SKY practices are considered low-risk and have been used in diverse populations; all data will be handled confidentially and securely.
This research is intended to lay the foundation for a larger study and provide early insight into how SKY breathwork practices may help students navigate academic demands with increased calm, clarity, and resilience.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sree K Patiballa, PhD
- Phone Number: 205-348-6163
- Email: spatiballa@ua.edu
Study Contact Backup
- Name: Kunwal M. Scott, DNP
- Email: kmscott10@ua.edu
Study Locations
-
-
Alabama
-
Tuscaloosa, Alabama, United States, 35401
- Recruiting
- University of Alabama
-
Contact:
- Facilities and Grounds Main University of Alabama Contant Number
- Phone Number: 205-348-6010
- Email: property@ua.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Participants must:
- be currently enrolled as undergraduate or graduate students at the university in Alabama;
- be at least 18 years old;
- speak and read English;
- be available to attend a 3-day in-person retreat and twice-weekly online sessions for SKY breath program over 8 weeks;
- be able to provide informed consent.
Exclusion Criteria:
Participants will be excluded if they:
- have a serious psychiatric condition (e.g., schizophrenia, psychotic disorders) that could be exacerbated by group-based interventions;
- are in acute psychiatric crisis; such as, active suicidal ideation
- have acute medical conditions that contraindicate light physical activity or breathwork;
- are unable to obtain physician clearance for participation due to chronic conditions (e.g., uncontrolled asthma, severe cardiovascular disease, active psychiatric illness requiring intensive treatment).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: control group will receive online Yoga Videos to practice at least three times a week
Yoga videos to practice three times per week will be distributed to control group
|
Pre-recorded yoga videos will be sent to the participants to perform yoga three times per week
|
|
Experimental: Intervention group
SKY breath meditation retreat for 3-days, once weekly online meditation session, and home practice.
|
Three day in person retreat, weekly virtual sessions, home practice
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
perceived stress scale
Time Frame: 8 weeks
|
measured by 10 items.
score ranges from 0 to 40.
Score of 0-13 would be considered low stress, score of 14-26 would be considered moderate stress, score of 27-40 would be considered high perceived stress.
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Generalized Anxiety Disorder Scale
Time Frame: 8 weeks
|
a seven item scale with score ranging from 0 to 21. score of 0-4: Minimal anxiety, score of 5-9: Mild anxiety, 10-14: Moderate anxiety, and 15-21: Severe anxiety.
|
8 weeks
|
|
International physical activity scale - short form
Time Frame: 8 weeks
|
a seven-item scale with open ended questions for recalling physical activity.
|
8 weeks
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Scott, K., Andrabi, M., Patiballa, S. K., McCoy, T., Shrestha, S., & Mumba, M. (2026). Breath of Resilience: Evaluating the Impact of SKY Breath Meditation on Stress, Well-being, and Connection in College Students - A Pilot Feasibility Randomized Controlled Trial
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25-11-9227
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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