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Time, Touch, Attention and the Autonomic Nervous System

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ClinicalTrials.gov Identifier: NCT01428674
Recruitment Status : Completed
First Posted : September 5, 2011
Last Update Posted : March 20, 2017
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Stress Other: Interpersonal Mindful Compassion with Touch Other: Reading while extending loving kindness Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Impact of Interpersonal Mindful Compassion on Autonomic Nervous System Function
Study Start Date : February 2011
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011
Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: 10 minutes reading Other: Reading while extending loving kindness
The practitioner sits in a room with the participant, pretending to read, while extending loving kindness to the participant.
Experimental: 20 minutes touch Other: Interpersonal Mindful Compassion with 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 Other: Reading while extending loving kindness
The practitioner sits in a room with the participant, pretending to read, while extending loving kindness to the participant.
Experimental: 10 minutes touch Other: Interpersonal Mindful Compassion with Touch
A practitioner lightly touches the participant on the hands, arms, shoulders, lower legs and feet while extending loving kindness to the participant.


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy subjects age 18 - 40

Exclusion Criteria:

  • Taking beta blocker medication
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01428674


Sponsors and Collaborators
Wake Forest University
Investigators
Principal Investigator: Kathi J Kemper, MD Wake Forest University Health Sciences
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Wake Forest University
ClinicalTrials.gov Identifier: NCT01428674     History of Changes
Other Study ID Numbers: WFUIRB00015699
First Posted: September 5, 2011    Key Record Dates
Last Update Posted: March 20, 2017
Last Verified: March 2017

Keywords provided by Wake Forest University Health Sciences ( Wake Forest University ):
Interpersonal mindful compassion
Loving kindness meditation
Autonomic Nervous System
 Heart rate variability
Respiratory rate
Relaxation