Comparing the Effects of Yoga Nidra to Yoga Nidra With Pain Acceptance Intention and Motor Imagery on Pain Outcomes

Yoga Nidra is a scripted mind-body intervention (MBI) that uses guided relaxation technique in a reproducible sequence of mechanisms that naturally produce a parasympathetic response. This is a randomized controlled trial in which participants will be randomly assigned to one of three interventions: 1) yoga nidra (Yoga Nidra Script Basic), 2) yoga nidra with pain acceptance (Yoga Nidra Acceptance Intention), 3) yoga nidra with pain acceptance and Explicit Motor Imagery (Yoga Nidra Acceptance Intention and Visualization).

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain
• Intervention / Treatment: Other: Yoga Nidra; Other: Yoga Nidra with Pain Acceptance Intention; Other: Yoga Nidra with Pain Acceptance Intervention and Motor Imagery

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Abigail Anderson, PT, DPT, PhD; Phone Number: 407-823-1026; Email: Abigail.Wilson@ucf.edu

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32816
      • Recruiting
      • University of Central Florida
      • Contact: Phone Number: 407-823-1026; Email: Abigail.Wilson@ucf.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Chronic pain in the neck, low back, shoulder, hip, elbow, knee, wrist, or ankle that has lasted for over three months
• Pain intensity rated as 3/10 or higher in the past 24 hours (0=no pain, 10=worst pain imaginable)

Exclusion Criteria:

• non-English speaking
• systemic medical conditions that affect sensation (such as uncontrolled diabetes)
• History of surgery or fracture within the past six months
• any blood clotting disorders (such as hemophilia)
• any contraindication to the application of ice (blood pressure > 140/90 mmHg, cold urticaria, cryoglobulinemia, paroxysmal cold hemoglobinuria, circulatory compromise)
• Exceed pressure and heat sensory thresholds
• Unable to access internet or email
• Pregnant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Yoga Nidra; This protocol is derived from The Origin and Clinical Relevance of Yoga Nidra (Pandi-Perumal, S. R. 2022) and is approximately 20 minutes total time.	Other: Yoga Nidra; This protocol is derived from The Origin and Clinical Relevance of Yoga Nidra (Pandi-Perumal, S. R. 2022)
Active Comparator: Yoga Nidra and Pain Acceptance Intention; Yoga Nidra plus a Pain Acceptance Intention.	Other: Yoga Nidra with Pain Acceptance Intention; Yoga Nidra with Pain Acceptance Intention
Active Comparator: Yoga Nidra with Pain Acceptance Intervention and Motor Imagery; Yoga Nidra plus pain acceptance and motor imagery	Other: Yoga Nidra with Pain Acceptance Intervention and Motor Imagery; Yoga Nidra with Pain Acceptance Intervention and Motor Imagery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pressure Pain Threshold	A computerized pressure algometer (AlgoMed, Ramat Yishai, Israel) with a 1 cm diameter rubber tip will be applied to the upper trapezius.	Pre/Post intervention, Day 1
Temporal Summation	Change in pain ratings during 10 heat pulses will be recorded.	Pre/Post intervention, Day 1
Conditioned Pain Modulation	Pressure pain threshold after a cold water immersion task.	Pre/Post intervention, Day 1
Heat Pain Threshold	Participants will report when comfortable heat becomes painful by pressing a button. Temperature in degrees Celsius will be recorded at threshold	Pre/Post intervention, Day 1

Collaborators and Investigators

• Sponsor: University of Central Florida
• Investigators: Principal Investigator: Abigail Anderson, PT, DPT, PhD, University of Central Florida

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2024
• Primary Completion (Estimated): September 15, 2025
• Study Completion (Estimated): September 15, 2025

Study Registration Dates

• First Submitted: August 29, 2024
• First Submitted That Met QC Criteria: September 5, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): December 5, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: chronic pain; meditation
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: YN10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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