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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04571593
Other study ID # ESRB41320
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 15, 2020
Est. completion date September 14, 2020

Study information

Verified date November 2023
Source National University of Natural Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this application is to collect survey data indicating the effects of a digital Yoga Nidra practice on anxiety and sleep during COVID-19. We will explore effects on momentary anxiousness, as well as on sleep. Participants will be consented through REDCap during the Yoga Nidra class, then asked to complete an intake form, a sleep questionnaire (composed of questions from the Post Sleep Questionnaire (PSQ)) and a pre/post State Trait Anxiety (STAI) Index, surrounding the practice. Participants will receive an email the next morning, inquiring about their sleep (~2 min survey), and again the following week, the morning of the Yoga Nidra class, in order to remind them about the weekly class offering and also to collect sleep data for a night that did not include pre-bed Yoga Nidra. We will additionally report feasibility measures including enrollment, retention, qualitative feedback, and challenges of using the digital platform. Using this data, we will gain valuable feasibility data for implementation of this type of mind-body practice using digital platforms. We will also gain important data on the effects of this practice on anxiety and sleep.


Recruitment information / eligibility

Status Completed
Enrollment 74
Est. completion date September 14, 2020
Est. primary completion date August 5, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adults - Can understand a recording in English while resting comfortably Exclusion Criteria: NA

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Yoga Nidra
The practice of Yoga Nidra, is a scripted and reproducible, guided meditation technique that promotes mental, emotional and physical relaxation while also facilitating the transition between waking and sleeping.

Locations

Country Name City State
United States National University of Natural Medicine, Helfgott Research Institute Portland Oregon

Sponsors (1)

Lead Sponsor Collaborator
National University of Natural Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Momentary Anxiety State Trait Anxiety (STAI-6) Short Form (scale 20 to 80, with higher scores indicating higher momentary anxiety) Pre-intervention and immediately after the intervention
Primary Change in Sleep Quality Post Sleep Questionnaire (PSQ): six questions Baseline (pre-intervention), 1 day (morning after intervention), and 2-6 days later (survey sent each Tuesday, to capture a night without Yoga Nidra)
Secondary Incidence of Intervention-Emergent Challenges as assessed by a Feedback Survey Qualitative Feedback Survey (developed in-house) Post-intervention (survey sent at 16 weeks)
Secondary Satisfaction as assessed by a Feedback Survey Qualitative Feedback Survey (developed in-house) Post-intervention (survey sent at 16-weeks)
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