Remote Yoga Nidra for Anxiety and Sleep

Digital Delivery of Yoga Nidra for Anxiety and Sleep: A Feasibility Study

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.

Study Overview

• Status: Completed
• Conditions: Insomnia Due to Anxiety and Fear
• Intervention / Treatment: Behavioral: Yoga Nidra

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97201
      • National University of Natural Medicine, Helfgott Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria: NA

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Digital Yoga Nidra; 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Intervention-Emergent Challenges as assessed by a Feedback Survey	Qualitative Feedback Survey (developed in-house)	Post-intervention (survey sent at 16 weeks)
Satisfaction as assessed by a Feedback Survey	Qualitative Feedback Survey (developed in-house)	Post-intervention (survey sent at 16-weeks)

Collaborators and Investigators

• Sponsor: National University of Natural Medicine
• Investigators: Principal Investigator: Erica M Sharpe, PhD, National University of Natural Medicine

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2020
• Primary Completion (Actual): August 5, 2020
• Study Completion (Actual): September 14, 2020

Study Registration Dates

• First Submitted: September 17, 2020
• First Submitted That Met QC Criteria: September 25, 2020
• First Posted (Actual): October 1, 2020

Study Record Updates

• Last Update Posted (Estimated): November 20, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: ESRB41320

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Protocol, analysis and consent are shared.
• IPD Sharing Time Frame: Available
• IPD Sharing Access Criteria: Uploaded to clinicaltrials.gov
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No