Psychological and Physiological Effects of Different Objects of Breath Meditation

Psychological Stress Clinical Trial

Official title:

Psychological and Physiological Effects of Different Objects of Breath Meditation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06051500
• Other study ID #: 2023-0749
• Secondary ID: Protocol Version
• Status: Recruiting
• Phase: N/A
• Start date: October 20, 2023
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: University of Wisconsin, Madison
• Contact: Canaan D Bracey
• Phone: 18322705523
• Email: cdbracey[@]wisc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emotions
• Physiological Stress
• Psychological Stress
• Stress, Psychological

Intervention

Behavioral:
• Nostril focus followed by belly focus
Focused breathing on the nostrils followed by focus breathing on the belly.
• Belly focus followed by nostril focus
Focused breathing on the bellyfollowed by focus breathing on the nostrils.

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	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.	Baseline only
Secondary	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.	At baseline; after meditation 1 (5 minutes); and, after meditation 2 (15 minutes)
Secondary	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.	At baseline; after meditation 1 (5 minutes); and, after meditation 2 (15 minutes)
Secondary	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.	At baseline; after meditation 1 (5 minutes); and, after meditation 2 (15 minutes)
Secondary	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.	At baseline; after meditation 1 (5 minutes); and, after meditation 2 (15 minutes)