StressNCT01428674
Time, Touch, Attention and the Autonomic Nervous System
A study testing Interpersonal Mindful Compassion with Touch and Reading while extending loving kindness in people with Stress, run by Wake Forest University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Interpersonal Mindful Compassion with Touch and Reading while extending loving kindness
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Feb 2011to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects age 18 - 40
Who cannot join
- Taking beta blocker medication
About this study
Official title: 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.
- Conditions
- Stress
- Being tested
- Interpersonal Mindful Compassion with Touch, Reading while extending loving kindness
- Keywords
- Interpersonal mindful compassion, Loving kindness meditation, Autonomic Nervous System, Heart rate variability, Respiratory rate, Relaxation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interpersonal Mindful Compassion with TouchOther
A practitioner lightly touches the participant on the hands, arms, shoulders, lower legs and feet while extending loving kindness to the participant.
Reading while extending loving kindnessOther
The practitioner sits in a room with the participant, pretending to read, while extending loving kindness to the participant.
| Study group | Role | What they receive |
|---|---|---|
| 10 minutes reading | Experimental | Not described Receives: Other: Reading while extending loving kindness |
| 20 minutes touch | Experimental | Not described Receives: Other: Interpersonal Mindful Compassion with Touch |
| 20 minutes reading | Experimental | Not described Receives: Other: Reading while extending loving kindness |
| 10 minutes touch | Experimental | Not described Receives: Other: Interpersonal Mindful Compassion with Touch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Heart Rate Variability from pre-intervention period to intervention period
Measured: 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
Measured: continuous monitoring for 10 minutes before intervention and during 10 or 20 minute intervention
Secondary outcomes (1)
Perceived Stress, Relaxation, Peacefulness
Measured: baseline, after a 10 minute rest period, before 10 or 20 minute intervention, immediately after intervention, 20 minutes after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2011 (estimated)
- Study startFeb 2011
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kathi J Kemper, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01428674
- Sponsor's protocol ID
- IRB00015699
- Status last verified
- Aug 2018
- First submitted
- 30 Aug 2011
- Last updated
- 15 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 22185349
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Interpersonal Mindful Compassion on Autonomic Nervous System Function
- ClinicalTrials.gov ID
- NCT01428674
- Acronym / sponsor ID
- IRB00015699
- Conditions
- Stress
- Keywords
- Interpersonal mindful compassion, Loving kindness meditation, Autonomic Nervous System, Heart rate variability, Respiratory rate, Relaxation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Wake Forest UniversityUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 5 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy subjects age 18 - 40
Key exclusion criteria (1 listed)
- Taking beta blocker medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interpersonal Mindful Compassion with TouchA practitioner lightly touches the participant on the hands, arms, shoulders, lower legs and feet while extending loving kindness to the participant. | Other | 10 minutes touch, 20 minutes touch |
| Reading while extending loving kindnessThe practitioner sits in a room with the participant, pretending to read, while extending loving kindness to the participant. | Other | 10 minutes reading, 20 minutes reading |
Primary outcome
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
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2018.
- Derived from this study: PubMed 22185349Kemper 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathi J Kemper, MD principal investigator
Wake Forest University Health Sciences
Questions about this trial
What is this clinical trial studying?
A study testing Interpersonal Mindful Compassion with Touch and Reading while extending loving kindness in people with Stress, run by Wake Forest University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01428674, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2018.