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Remote Yoga Nidra for Anxiety and Sleep

Primary Purpose

Insomnia Due to Anxiety and Fear

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Yoga Nidra
Sponsored by
National University of Natural Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Insomnia Due to Anxiety and Fear

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Adults
  • Can understand a recording in English while resting comfortably

Exclusion Criteria: NA

Sites / Locations

  • National University of Natural Medicine, Helfgott Research Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Digital Yoga Nidra

Arm Description

Participants will voluntarily complete a ~30-minute remote Yoga Nidra practice, synchronously (through Zoom Wednesdays at 10 pm ET) or asynchronously (through YouTube, using the Zoom recording, any time they like). They may voluntarily repeat this practice as often as they like. Recordings are updated weekly, to reflect the ongoing Zoom class. Yoga Nidra scripts from Satyananda Saraswati's "Yoga Nidra" book (1976) are used for this class.

Outcomes

Primary Outcome Measures

Change in Momentary Anxiety
State Trait Anxiety (STAI-6) Short Form (scale 20 to 80, with higher scores indicating higher momentary anxiety)
Change in Sleep Quality
Post Sleep Questionnaire (PSQ): six questions

Secondary Outcome Measures

Incidence of Intervention-Emergent Challenges as assessed by a Feedback Survey
Qualitative Feedback Survey (developed in-house)
Satisfaction as assessed by a Feedback Survey
Qualitative Feedback Survey (developed in-house)

Full Information

First Posted
September 17, 2020
Last Updated
September 30, 2020
Sponsor
National University of Natural Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04571593
Brief Title
Remote Yoga Nidra for Anxiety and Sleep
Official Title
Digital Delivery of Yoga Nidra for Anxiety and Sleep: A Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
April 15, 2020 (Actual)
Primary Completion Date
August 5, 2020 (Actual)
Study Completion Date
September 14, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University of Natural Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia Due to Anxiety and Fear

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Digital Yoga Nidra
Arm Type
Experimental
Arm Description
Participants will voluntarily complete a ~30-minute remote Yoga Nidra practice, synchronously (through Zoom Wednesdays at 10 pm ET) or asynchronously (through YouTube, using the Zoom recording, any time they like). They may voluntarily repeat this practice as often as they like. Recordings are updated weekly, to reflect the ongoing Zoom class. Yoga Nidra scripts from Satyananda Saraswati's "Yoga Nidra" book (1976) are used for this class.
Intervention Type
Behavioral
Intervention Name(s)
Yoga Nidra
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Momentary Anxiety
Description
State Trait Anxiety (STAI-6) Short Form (scale 20 to 80, with higher scores indicating higher momentary anxiety)
Time Frame
Pre-intervention and immediately after the intervention
Title
Change in Sleep Quality
Description
Post Sleep Questionnaire (PSQ): six questions
Time Frame
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 Outcome Measure Information:
Title
Incidence of Intervention-Emergent Challenges as assessed by a Feedback Survey
Description
Qualitative Feedback Survey (developed in-house)
Time Frame
Post-intervention (survey sent at 16 weeks)
Title
Satisfaction as assessed by a Feedback Survey
Description
Qualitative Feedback Survey (developed in-house)
Time Frame
Post-intervention (survey sent at 16-weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adults Can understand a recording in English while resting comfortably Exclusion Criteria: NA
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erica M Sharpe, PhD
Organizational Affiliation
National University of Natural Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
National University of Natural Medicine, Helfgott Research Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Protocol, analysis and consent are shared.
IPD Sharing Time Frame
Available
IPD Sharing Access Criteria
Uploaded to clinicaltrials.gov

Learn more about this trial

Remote Yoga Nidra for Anxiety and Sleep

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