- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01428674
Time, Touch, Attention and the Autonomic Nervous System
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Healthy subjects age 18 - 40
Exclusion Criteria:
- Taking beta blocker medication
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 10 minutes reading
|
The practitioner sits in a room with the participant, pretending to read, while extending loving kindness to the participant.
|
|
Eksperimentel: 20 minutes touch
|
A practitioner lightly touches the participant on the hands, arms, shoulders, lower legs and feet while extending loving kindness to the participant.
|
|
Eksperimentel: 20 minutes reading
|
The practitioner sits in a room with the participant, pretending to read, while extending loving kindness to the participant.
|
|
Eksperimentel: 10 minutes touch
|
A practitioner lightly touches the participant on the hands, arms, shoulders, lower legs and feet while extending loving kindness to the participant.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change in Heart Rate Variability from pre-intervention period to intervention period
Tidsramme: continuous monitoring for 10 min before intervention and during 10 or 20 minute intervention
|
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
Tidsramme: continuous monitoring for 10 minutes before intervention and during 10 or 20 minute intervention
|
continuous monitoring for 10 minutes before intervention and during 10 or 20 minute intervention
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Perceived Stress, Relaxation, Peacefulness
Tidsramme: baseline, after a 10 minute rest period, before 10 or 20 minute intervention, immediately after intervention, 20 minutes after intervention
|
baseline, after a 10 minute rest period, before 10 or 20 minute intervention, immediately after intervention, 20 minutes after intervention
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Kathi J Kemper, MD, Wake Forest University Health Sciences
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- IRB00015699 (Anden identifikator: JHSPH IRB)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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