NCT06051500

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 25, 2023

Completed
25 days until next milestone

Study Start

First participant enrolled

October 20, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2024

Completed
Last Updated

June 6, 2024

Status Verified

June 1, 2024

Enrollment Period

7 months

First QC Date

September 11, 2023

Last Update Submit

June 4, 2024

Conditions

Keywords

meditationfocusattentionbreath

Outcome Measures

Primary Outcomes (3)

  • Change in Positive and Negative Affect Schedule (PANAS-SF)

    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

    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

    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 Outcomes (5)

  • Perseverative Thinking (PTQ)

    Baseline only

  • Change in Interoceptive Awareness

    At baseline; after meditation 1 (5 minutes); and, after meditation 2 (15 minutes)

  • Change in Mindfulness

    At baseline; after meditation 1 (5 minutes); and, after meditation 2 (15 minutes)

  • Change in Relaxation

    At baseline; after meditation 1 (5 minutes); and, after meditation 2 (15 minutes)

  • Change in Focus

    At baseline; after meditation 1 (5 minutes); and, after meditation 2 (15 minutes)

Study Arms (2)

Nostril focus followed by belly focus

EXPERIMENTAL

Participants will be randomly assigned to concentrate on the nostrils first, then the belly second following a period of rest.

Behavioral: Nostril focus followed by belly focus

Belly focus followed by nostril focus

EXPERIMENTAL

Participants will be randomly assigned to concentrate on the belly first, then the nostrils second following a period of rest.

Behavioral: Belly focus followed by nostril focus

Interventions

Focused breathing on the nostrils followed by focus breathing on the belly.

Nostril focus followed by belly focus

Focused breathing on the bellyfollowed by focus breathing on the nostrils.

Belly focus followed by nostril focus

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • at least 18 years of age
  • student at UW Madison
  • no major history of meditation practice

You may not qualify if:

  • under 18 years of age
  • not currently enrolled at UW Madison
  • have previous meditation experience
  • Self-reports a mental health diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Matthew Hirshberg, PhD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Random allocation to one of two sequence of meditation practice.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2023

First Posted

September 25, 2023

Study Start

October 20, 2023

Primary Completion

May 2, 2024

Study Completion

May 2, 2024

Last Updated

June 6, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

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).

Locations