Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Time, Touch, Attention and the Autonomic Nervous System

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kathi J. Kemper, Wake Forest University
ClinicalTrials.gov Identifier:
NCT01428674
First received: August 30, 2011
Last updated: September 2, 2011
Last verified: September 2011
  Purpose

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 Intervention
Stress
Other: Interpersonal Mindful Compassion with Touch
Other: Reading while extending loving kindness

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Impact of Interpersonal Mindful Compassion on Autonomic Nervous System Function

Further study details as provided by Wake Forest School of Medicine:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: February 2011
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy subjects age 18 - 40

Exclusion Criteria:

  • Taking beta blocker medication
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01428674

Sponsors and Collaborators
Wake Forest School of Medicine
Investigators
Principal Investigator: Kathi J Kemper, MD Wake Forest School of Medicine
  More Information

No publications provided by Wake Forest School of Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kathi J. Kemper, Professor, Wake Forest University
ClinicalTrials.gov Identifier: NCT01428674     History of Changes
Other Study ID Numbers: WFUIRB00015699
Study First Received: August 30, 2011
Last Updated: September 2, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest School of Medicine:
Interpersonal mindful compassion
Loving kindness meditation
Autonomic Nervous System
Heart rate variability
Respiratory rate
Relaxation

ClinicalTrials.gov processed this record on November 20, 2014