Remote Yoga Nidra for Anxiety and Sleep

NCT04571593 | Completed

• 1 other identifier: ESRB41320
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia Due to Anxiety and Fear

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Incidence of Intervention-Emergent Challenges as assessed by a Feedback Survey

  Post-intervention (survey sent at 16 weeks)

• Satisfaction as assessed by a Feedback Survey

  Post-intervention (survey sent at 16-weeks)

Study Arms (1)

Digital Yoga Nidra

EXPERIMENTAL

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

Interventions

Yoga Nidra BEHAVIORAL

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.

Digital Yoga Nidra

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• National University of Natural Medicine: lead

Study Sites (1)

National University of Natural Medicine, Helfgott Research Institute

Portland, Oregon, 97201, United States

Location

Study Officials

• Erica M Sharpe, PhD

  National University of Natural Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Investigator

Study Record Dates

• First Submitted: September 17, 2020
• First Posted: October 1, 2020
• Study Start: April 15, 2020
• Primary Completion: August 5, 2020
• Study Completion: September 14, 2020
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Available
• Access Criteria: Uploaded to clinicaltrials.gov

Locations

US (1)