- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01428674
Time, Touch, Attention and the Autonomic Nervous System
The Impact of Interpersonal Mindful Compassion on Autonomic Nervous System Function
The purpose of this study is to describe the onset, duration and dose-response of interpersonal mindful compassion on respiratory rate and heart rate variability in healthy adults in order to prepare for research evaluating the impact of this intervention in patient populations and to prepare for basic research investigating the CNS mechanisms for observed effects.
Previous research has found that mindfulness meditation, including mindful compassion, results in autonomic changes in the practitioner. Emerging neuroscience of dyadic interactions suggests that through the effects of mirror neuron isopraxis, one person's physiologic state may be mirrored by another. However, no research has directly evaluated the impact of one person's mindful compassion on another person's autonomic activity. This study paves the way for an entirely new avenue of research inquiry.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy subjects age 18 - 40
Exclusion Criteria:
- Taking beta blocker medication
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 10 minutes reading
|
The practitioner sits in a room with the participant, pretending to read, while extending loving kindness to the participant.
|
Experimental: 20 minutes touch
|
A practitioner lightly touches the participant on the hands, arms, shoulders, lower legs and feet while extending loving kindness to the participant.
|
Experimental: 20 minutes reading
|
The practitioner sits in a room with the participant, pretending to read, while extending loving kindness to the participant.
|
Experimental: 10 minutes touch
|
A practitioner lightly touches the participant on the hands, arms, shoulders, lower legs and feet while extending loving kindness to the participant.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Heart Rate Variability from pre-intervention period to intervention period
Time Frame: continuous monitoring for 10 min before intervention and during 10 or 20 minute intervention
|
continuous monitoring for 10 min before intervention and during 10 or 20 minute intervention
|
Change in Respiratory Rate from pre-intervention period to intervention period
Time Frame: continuous monitoring for 10 minutes before intervention and during 10 or 20 minute intervention
|
continuous monitoring for 10 minutes before intervention and during 10 or 20 minute intervention
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Perceived Stress, Relaxation, Peacefulness
Time Frame: baseline, after a 10 minute rest period, before 10 or 20 minute intervention, immediately after intervention, 20 minutes after intervention
|
baseline, after a 10 minute rest period, before 10 or 20 minute intervention, immediately after intervention, 20 minutes after intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kathi J Kemper, MD, Wake Forest University Health Sciences
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IRB00015699 (Other Identifier: JHSPH IRB)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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