- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01975415
Digital Medicine in Meditation (DigMed2)
12. marts 2014 opdateret af: Scripps Translational Science Institute
This study will investigate the acute response to meditation during a week-long meditation retreat at the Chopra Center as measured by the continuous, simultaneous monitoring of numerous biometric parameters in selected cohorts of experienced and novice meditators during periods of meditation and specific breathing techniques.
Comparisons between cohorts as well as over time will allow for the identification of meditation and/or breathing-related changes.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
The biometric responses to meditation and breathing techniques will be compared between novice and experienced meditators, as well as initial versus final biometric responses in all participants stratified by cohort.
Investigators hypothesize that novice meditators will experience a measurable change in response to mediation over the week-long retreat, whereas experienced meditators will demonstrate a more robust response than novice meditators on the first day of the retreat with less change over the retreat.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
40
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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California
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Carlsbad, California, Forenede Stater, 92009
- The Chopra Center
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Participants in this study will be a subset of 40 individuals from a total of ~200 who self-selected to participate in a week-long "Seduction of Spirit" retreat at The Chopra Center in the La Costa Resort in Carlsbad, CA.
The 40 anticipated participants will be made up of 2 cohorts: experienced meditators and novice meditators.
Beskrivelse
Inclusion Criteria:
- Adult over age 18 who are already registered to participate in the week-long "Seduction of the Soul" retreat.
- Capable of providing informed consent
Exclusion Criteria:
- Chronic requirement for daily use of chronotropically active medications including beta-blockers, non-dihydropyridine calcium channel blockers, clonidine or beta-agonist inhalers.
- Implantable pacemaker or cardioverter-defibrillator.
- Known allergy to adhesives.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
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Experienced Meditators
Self-identified participants who confirm to having a regular meditation practice for at least 3 months and practiced at least 70 minutes per week.
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Novice meditators
Self-identified participant who confirm to either having never seriously tried meditation, or who have not meditated more than once a week for at least 3 months
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Blood Pressure
Tidsramme: Participants will be measured at Day 1 and Day 5 of retreat
|
Non-invasive blood pressure
|
Participants will be measured at Day 1 and Day 5 of retreat
|
|
ECG
Tidsramme: Participants will be measured at Day 1 and Day 5 of retreat
|
5-lead electrocardiogram
|
Participants will be measured at Day 1 and Day 5 of retreat
|
|
Respiration rate
Tidsramme: Participants will be measured at Day 1 and Day 5 of retreat
|
Respiration rate
|
Participants will be measured at Day 1 and Day 5 of retreat
|
|
Heart Rate
Tidsramme: Participants will be measured at Day 1 and Day 5 of retreat
|
Heart rate
|
Participants will be measured at Day 1 and Day 5 of retreat
|
|
Oxygen saturation (SpO2)
Tidsramme: Participants will be measured at Day 1 and Day 5 of retreat
|
Oxygen saturation
|
Participants will be measured at Day 1 and Day 5 of retreat
|
|
Skin temperature
Tidsramme: Participants will be measured at Day 1 and Day 5 of retreat
|
Skin temperature
|
Participants will be measured at Day 1 and Day 5 of retreat
|
|
Heart rate variability
Tidsramme: Participants will be measured at Day 1 and Day 5 of retreat
|
Variability in heart rate across a period of time.
|
Participants will be measured at Day 1 and Day 5 of retreat
|
|
EEG
Tidsramme: Participants will be measured at Day 1 and Day 5 of retreat
|
14-lead Electroencephalogram
|
Participants will be measured at Day 1 and Day 5 of retreat
|
|
Stress level
Tidsramme: Participants will be measured at Day 1 and Day 5 of retreat
|
Stress level calculated from heart rate variability
|
Participants will be measured at Day 1 and Day 5 of retreat
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. oktober 2013
Primær færdiggørelse (Faktiske)
1. november 2013
Studieafslutning (Faktiske)
1. november 2013
Datoer for studieregistrering
Først indsendt
17. oktober 2013
Først indsendt, der opfyldte QC-kriterier
28. oktober 2013
Først opslået (Skøn)
3. november 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
13. marts 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. marts 2014
Sidst verificeret
1. marts 2014
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 13 - 6251
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .