Psychological and Physiological Effects of Different Objects of Breath Meditation

October 31, 2023 updated by: University of Wisconsin, Madison

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

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

Interventional

Enrollment (Estimated)

150

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

Study Contact Backup

Study Locations

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

Yes

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

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: 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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Matthew Hirshberg, PhD, University of Wisconsin, Madison

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)

October 20, 2023

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

September 11, 2023

First Submitted That Met QC Criteria

September 19, 2023

First Posted (Actual)

September 25, 2023

Study Record Updates

Last Update Posted (Actual)

November 1, 2023

Last Update Submitted That Met QC Criteria

October 31, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

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)?

NO

IPD Plan Description

After de-identification, all processed study data will be posted to support open science practices. Heart rate and respiration indices will be posted after processing (i.e., not raw data).

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.

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