- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06051500
Psychological and Physiological Effects of Different Objects of Breath Meditation
The goal of this research is to test whether certain areas of focus in breath meditation are connected with certain mental health outcomes. The main question to be addressed is whether attention placed on the breath in the belly versus the nostrils during meditation results in differences in subjective experience, respiration and heart rate.
Participants will:
- complete surveys
- have heart rate and respiration measured
- practice focused breathing
Participants can expect the study visit to last for one hour.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
An online prescreen will determine eligibility. Participants that 1) are under 18, 2) are not students currently enrolled at UW-Madison 3) have previous mediation experience 4) obtain a high PROMIS depression or anxiety score, or 5) have been diagnosed with one or more psychiatric disorders by a healthcare professional that will be listed in the pre-screen survey will be excluded.
Participants deemed eligible following prescreen will schedule a lab visit. At the beginning of the lab visit, participants will be provided a consent document and time to ask questions. After signing the consent form, researchers will place ECG leads and a respiration belt on participants, and then complete the baseline survey battery. Participants will then sit at rest for 5 minutes of baseline heart rate and respiration data collection. Next, participants will be randomly assigned in a counterbalanced order to nostril focus first or belly focus first and asked to follow a brief (~5 minute) guided practice. After the practice, participants will complete a second battery of self-reports and then have a 10-minute period of rest/recovery. They will then complete the second practice (~5 minutes) followed by a final survey. The entire session will take about an hour.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Canaan D Bracey
- Phone Number: 18322705523
- Email: cdbracey@wisc.edu
Study Contact Backup
- Name: Matthew D Hirshberg, PhD
- Phone Number: 6082620035
- Email: hirshberg@wisc.edu
Study Locations
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53705
- Recruiting
- University of Wisconsin
-
Contact:
- Canaan Bracey
- Email: cdbracey@wisc.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- at least 18 years of age
- student at UW Madison
- no major history of meditation practice
Exclusion Criteria:
- under 18 years of age
- not currently enrolled at UW Madison
- have previous meditation experience
- Self-reports a mental health diagnosis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Nostril focus followed by belly focus
Participants will be randomly assigned to concentrate on the nostrils first, then the belly second following a period of rest.
|
Focused breathing on the nostrils followed by focus breathing on the belly.
|
Experimental: Belly focus followed by nostril focus
Participants will be randomly assigned to concentrate on the belly first, then the nostrils second following a period of rest.
|
Focused breathing on the bellyfollowed by focus breathing on the nostrils.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Positive and Negative Affect Schedule (PANAS-SF)
Time Frame: At baseline; after meditation 1 (5 minutes); and, after meditation 2 (15 minutes)
|
PANAS-SF is a 20-item questionnaire to assess positive versus negative affect.
10 of the items indicate positive affect, 10 indicate negative.
Scores can range between 10-50 for positive affect, with higher scores representing higher levels of positive affect.
Scores can range between 10-50 for negative affect, with lower scores representing lower levels of negative affect.
|
At baseline; after meditation 1 (5 minutes); and, after meditation 2 (15 minutes)
|
Change in Respiration
Time Frame: Baseline to practice 1 epoch (10 minutes); baseline 2 to practice 2 epoch (25minutes)
|
Using respiration belts, rate of respiration will be collected.
Paired with heart rate, this will give us further insight into the physiological responses to the participant's experience of the two variations of breath meditation.
|
Baseline to practice 1 epoch (10 minutes); baseline 2 to practice 2 epoch (25minutes)
|
Change in Heart Rate
Time Frame: Baseline to practice 1 epoch (10 minutes); baseline 2 to practice 2 epoch (25minutes)
|
Using ECG electrodes and a BIOPAC system, heart rate will be monitored.
Paired with respiration rate, this will give us further insight into the physiological responses to the participant's experience of the two variations of breath meditation.
|
Baseline to practice 1 epoch (10 minutes); baseline 2 to practice 2 epoch (25minutes)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perseverative Thinking (PTQ)
Time Frame: Baseline only
|
The PTQ is a 15-item questionnaire asking how participants typically think about negative experiences or problems.
Scores can range from 0-60, with higher scores representing higher levels of perseverative thinking.
|
Baseline only
|
Change in Interoceptive Awareness
Time Frame: At baseline; after meditation 1 (5 minutes); and, after meditation 2 (15 minutes)
|
The Multidimensional Assessment of Interoceptive Awareness (MAIA) is a 37-item questionnaire that measures multiple dimensions of self-awareness.
The Noticing, Attention Regulation and Self-regulation scales will be used.
Scores range between from 0-20, 0-35 and 0-20, respectively, with higher scores represent higher interoceptive awareness.
|
At baseline; after meditation 1 (5 minutes); and, after meditation 2 (15 minutes)
|
Change in Mindfulness
Time Frame: At baseline; after meditation 1 (5 minutes); and, after meditation 2 (15 minutes)
|
The Five Facet Mindfulness Questionnaire (FFMQ) is a 39-item questionnaire.
The Non-react to inner experience and Act with awareness subscales will be used.
Scores can range from 7-35 and 8-40, respectively; higher scores represent higher levels of mindfulness facet.
|
At baseline; after meditation 1 (5 minutes); and, after meditation 2 (15 minutes)
|
Change in Relaxation
Time Frame: At baseline; after meditation 1 (5 minutes); and, after meditation 2 (15 minutes)
|
A research assistant or I will ask each participant to respond to the following statement: "In this moment I feel relaxed."
Participants will select one of the following responses: strongly disagree, slightly disagree, neither agree nor disagree, slightly agree, strongly agree.
|
At baseline; after meditation 1 (5 minutes); and, after meditation 2 (15 minutes)
|
Change in Focus
Time Frame: At baseline; after meditation 1 (5 minutes); and, after meditation 2 (15 minutes)
|
A research assistant or I will ask each participant to respond to the following statement: "In this moment I feel focused."
Participants will select one of the following responses: strongly disagree, slightly disagree, neither agree nor disagree, slightly agree, strongly agree.
|
At baseline; after meditation 1 (5 minutes); and, after meditation 2 (15 minutes)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Matthew Hirshberg, PhD, University of Wisconsin, Madison
Study record dates
Study Major Dates
Study Start (Actual)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-0749
- Protocol Version 06/28/2023 (Other Identifier: UW Madison)
- L&S/CTR FOR HEALTHY MINDS (Other Identifier: UW Madison)
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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