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

History of Changes

Tracking Information

First Received Date ^ICMJE

August 30, 2011

Last Updated Date

September 2, 2011

Start Date ^ICMJE

February 2011

Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01428674 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Time, Touch, Attention and the Autonomic Nervous System

Official Title ^ICMJE

The Impact of Interpersonal Mindful Compassion on Autonomic Nervous System Function

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Condition ^ICMJE

Stress

Intervention ^ICMJE

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.
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.

Study Arm (s)

Experimental: 10 minutes reading
Intervention: Other: Reading while extending loving kindness
Experimental: 20 minutes touch
Intervention: Other: Interpersonal Mindful Compassion with Touch
Experimental: 20 minutes reading
Intervention: Other: Reading while extending loving kindness
Experimental: 10 minutes touch
Intervention: Other: Interpersonal Mindful Compassion with Touch

Publications *

Kemper KJ, Shaltout HA. Non-verbal communication of compassion: measuring psychophysiologic effects. BMC Complement Altern Med. 2011 Dec 20;11:132. PubMed PMID: 22185349; PubMed Central PMCID: PMC3260157.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2011

Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Healthy subjects age 18 - 40

Exclusion Criteria:

Taking beta blocker medication

Gender

Both

Ages

18 Years to 40 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT01428674

Other Study ID Numbers ^ICMJE

WFUIRB00015699

Has Data Monitoring Committee

Yes

Responsible Party

Kathi J. Kemper, Wake Forest University

Study Sponsor ^ICMJE

Wake Forest University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Kathi J Kemper, MD

Wake Forest University

Information Provided By

Wake Forest University

Verification Date

September 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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