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Psychological and Physiological Effects of Different Objects of Breath Meditation

Primary Purpose

Physiological Stress, Psychological Stress, Emotions

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nostril focus followed by belly focus
Belly focus followed by nostril focus
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Physiological Stress focused on measuring meditation, focus, attention, breath

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Nostril focus followed by belly focus

Belly focus followed by nostril focus

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Perseverative Thinking (PTQ)
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.
Change in Interoceptive Awareness
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.
Change in Mindfulness
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.
Change in Relaxation
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.
Change in Focus
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.

Full Information

First Posted
September 11, 2023
Last Updated
September 19, 2023
Sponsor
University of Wisconsin, Madison
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1. Study Identification

Unique Protocol Identification Number
NCT06051500
Brief Title
Psychological and Physiological Effects of Different Objects of Breath Meditation
Official Title
Psychological and Physiological Effects of Different Objects of Breath Meditation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physiological Stress, Psychological Stress, Emotions
Keywords
meditation, focus, attention, breath

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Random allocation to one of two sequence of meditation practice.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nostril focus followed by belly focus
Arm Type
Experimental
Arm Description
Participants will be randomly assigned to concentrate on the nostrils first, then the belly second following a period of rest.
Arm Title
Belly focus followed by nostril focus
Arm Type
Experimental
Arm Description
Participants will be randomly assigned to concentrate on the belly first, then the nostrils second following a period of rest.
Intervention Type
Behavioral
Intervention Name(s)
Nostril focus followed by belly focus
Intervention Description
Focused breathing on the nostrils followed by focus breathing on the belly.
Intervention Type
Behavioral
Intervention Name(s)
Belly focus followed by nostril focus
Intervention Description
Focused breathing on the bellyfollowed by focus breathing on the nostrils.
Primary Outcome Measure Information:
Title
Change in Positive and Negative Affect Schedule (PANAS-SF)
Description
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.
Time Frame
At baseline; after meditation 1 (5 minutes); and, after meditation 2 (15 minutes)
Title
Change in Respiration
Description
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.
Time Frame
Baseline to practice 1 epoch (10 minutes); baseline 2 to practice 2 epoch (25minutes)
Title
Change in Heart Rate
Description
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.
Time Frame
Baseline to practice 1 epoch (10 minutes); baseline 2 to practice 2 epoch (25minutes)
Secondary Outcome Measure Information:
Title
Perseverative Thinking (PTQ)
Description
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.
Time Frame
Baseline only
Title
Change in Interoceptive Awareness
Description
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.
Time Frame
At baseline; after meditation 1 (5 minutes); and, after meditation 2 (15 minutes)
Title
Change in Mindfulness
Description
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.
Time Frame
At baseline; after meditation 1 (5 minutes); and, after meditation 2 (15 minutes)
Title
Change in Relaxation
Description
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.
Time Frame
At baseline; after meditation 1 (5 minutes); and, after meditation 2 (15 minutes)
Title
Change in Focus
Description
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.
Time Frame
At baseline; after meditation 1 (5 minutes); and, after meditation 2 (15 minutes)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Canaan D Bracey
Phone
18322705523
Email
cdbracey@wisc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew D Hirshberg, PhD
Phone
6082620035
Email
hirshberg@wisc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Hirshberg, PhD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Canaan Bracey
Email
cdbracey@wisc.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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).

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Psychological and Physiological Effects of Different Objects of Breath Meditation

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