Comparing the Effects of Yoga Nidra to Yoga Nidra With Pain Acceptance Intention and Motor Imagery on Pain Outcomes
1 other identifier
interventional
60
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable chronic-pain
Started Sep 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 29, 2024
CompletedStudy Start
First participant enrolled
September 12, 2024
CompletedFirst Posted
Study publicly available on registry
September 19, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2025
CompletedDecember 5, 2024
December 1, 2024
1 year
August 29, 2024
December 3, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
Study Arms (3)
Yoga Nidra
EXPERIMENTALThis protocol is derived from The Origin and Clinical Relevance of Yoga Nidra (Pandi-Perumal, S. R. 2022) and is approximately 20 minutes total time.
Yoga Nidra and Pain Acceptance Intention
ACTIVE COMPARATORYoga Nidra plus a Pain Acceptance Intention.
Yoga Nidra with Pain Acceptance Intervention and Motor Imagery
ACTIVE COMPARATORYoga Nidra plus pain acceptance and motor imagery
Interventions
This protocol is derived from The Origin and Clinical Relevance of Yoga Nidra (Pandi-Perumal, S. R. 2022)
Yoga Nidra with Pain Acceptance Intention
Yoga Nidra with Pain Acceptance Intervention and Motor Imagery
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Central Florida
Orlando, Florida, 32816, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Abigail Anderson, PT, DPT, PhD
University of Central Florida
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
August 29, 2024
First Posted
September 19, 2024
Study Start
September 12, 2024
Primary Completion
September 15, 2025
Study Completion
September 15, 2025
Last Updated
December 5, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share