Physiological StressNCT06051500
Psychological and Physiological Effects of Different Objects of Breath Meditation
A study testing Nostril focus followed by belly focus and Belly focus followed by nostril focus in people with Physiological Stress and Psychological Stress, run by University of Wisconsin, Madison at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physiological Stress, Psychological Stress, Emotions
- What is being tested?
- Nostril focus followed by belly focus and Belly focus followed by nostril focus
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2023to 2 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- at least 18 years of age
- student at UW Madison
- no major history of meditation practice
Who cannot join
- under 18 years of age
- not currently enrolled at UW Madison
- have previous meditation experience
- Self-reports a mental health diagnosis
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Physiological Stress, Psychological Stress, Emotions
- Being tested
- Nostril focus followed by belly focus, Belly focus followed by nostril focus
- Keywords
- meditation, focus, attention, breath
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nostril focus followed by belly focusBehavioural
Focused breathing on the nostrils followed by focus breathing on the belly.
Belly focus followed by nostril focusBehavioural
Focused breathing on the bellyfollowed by focus breathing on the nostrils.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Belly focus followed by nostril focus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline to practice 1 epoch (10 minutes); baseline 2 to practice 2 epoch (25minutes)
Secondary outcomes (5)
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.
Measured: Baseline only
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.
Measured: At baseline; after meditation 1 (5 minutes); and, after meditation 2 (15 minutes)
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.
Measured: At baseline; after meditation 1 (5 minutes); and, after meditation 2 (15 minutes)
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.
Measured: At baseline; after meditation 1 (5 minutes); and, after meditation 2 (15 minutes)
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.
Measured: At baseline; after meditation 1 (5 minutes); and, after meditation 2 (15 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start20 Oct 2023
- Primary completion2 May 2024
- Study completion2 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physiological StressStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Random allocation to one of two sequence of meditation practice.
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew Hirshberg, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06051500
- Sponsor's protocol ID
- 2023-0749
- Other IDs
- Protocol Version 06/28/2023, L&S/CTR FOR HEALTHY MINDS
- Status last verified
- Jun 2024
- First submitted
- 11 Sep 2023
- Last updated
- 6 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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).
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological and Physiological Effects of Different Objects of Breath Meditation
- ClinicalTrials.gov ID
- NCT06051500
- Acronym / sponsor ID
- 2023-0749
- Conditions
- Physiological Stress, Psychological Stress, Emotions
- Keywords
- meditation, focus, attention, breath
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- 2 May 2024 (actual)
- Study completion
- 2 May 2024 (actual)
- First posted
- 25 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Random allocation to one of two sequence of meditation practice.
| Arm | Type | Receives |
|---|---|---|
| Nostril focus followed by belly focus | Experimental | Behavioral: Nostril focus followed by belly focusParticipants will be randomly assigned to concentrate on the nostrils first, then the belly second following a period of rest. |
| Belly focus followed by nostril focus | Experimental | Behavioral: Belly focus followed by nostril focusParticipants will be randomly assigned to concentrate on the belly first, then the nostrils second following a period of rest. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- at least 18 years of age
- student at UW Madison
- no major history of meditation practice
Key exclusion criteria (4 listed)
- under 18 years of age
- not currently enrolled at UW Madison
- have previous meditation experience
- Self-reports a mental health diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nostril focus followed by belly focusFocused breathing on the nostrils followed by focus breathing on the belly. | Behavioural | Nostril focus followed by belly focus |
| Belly focus followed by nostril focusFocused breathing on the bellyfollowed by focus breathing on the nostrils. | Behavioural | Belly focus followed by nostril focus |
Primary outcome
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.
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.
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.
5 secondary outcomes
Perseverative Thinking (PTQ)
Time frame: Baseline only
Change in Interoceptive Awareness
Time frame: 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)
Change in Relaxation
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Hirshberg, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nostril focus followed by belly focus and Belly focus followed by nostril focus in people with Physiological Stress and Psychological Stress, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Positive and Negative Affect Schedule (PANAS-SF) (time frame: At baseline; after meditation 1 (5 minutes); and, after meditation 2 (15 minutes)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2024.