NCT01428674

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2011

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 5, 2011

Completed
Last Updated

August 15, 2018

Status Verified

August 1, 2018

Enrollment Period

4 months

First QC Date

August 30, 2011

Last Update Submit

August 13, 2018

Conditions

Keywords

Interpersonal mindful compassionLoving kindness meditationAutonomic Nervous SystemHeart rate variabilityRespiratory rateRelaxation

Outcome Measures

Primary Outcomes (2)

  • Change in Heart Rate Variability from pre-intervention period to intervention period

    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

    continuous monitoring for 10 minutes before intervention and during 10 or 20 minute intervention

Secondary Outcomes (1)

  • Perceived Stress, Relaxation, Peacefulness

    baseline, after a 10 minute rest period, before 10 or 20 minute intervention, immediately after intervention, 20 minutes after intervention

Study Arms (4)

10 minutes reading

EXPERIMENTAL
Other: Reading while extending loving kindness

20 minutes touch

EXPERIMENTAL
Other: Interpersonal Mindful Compassion with Touch

20 minutes reading

EXPERIMENTAL
Other: Reading while extending loving kindness

10 minutes touch

EXPERIMENTAL
Other: Interpersonal Mindful Compassion with Touch

Interventions

A practitioner lightly touches the participant on the hands, arms, shoulders, lower legs and feet while extending loving kindness to the participant.

10 minutes touch20 minutes touch

The practitioner sits in a room with the participant, pretending to read, while extending loving kindness to the participant.

10 minutes reading20 minutes reading

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy subjects age 18 - 40

You may not qualify if:

  • Taking beta blocker medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Kemper KJ, Shaltout HA. Non-verbal communication of compassion: measuring psychophysiologic effects. BMC Complement Altern Med. 2011 Dec 20;11:132. doi: 10.1186/1472-6882-11-132.

MeSH Terms

Interventions

Touch

Intervention Hierarchy (Ancestors)

SensationNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Kathi J Kemper, MD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2011

First Posted

September 5, 2011

Study Start

February 1, 2011

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

August 15, 2018

Record last verified: 2018-08