NCT06590181

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

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for not_applicable chronic-pain

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

Completed
14 days until next milestone

Study Start

First participant enrolled

September 12, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2025

Completed
Last Updated

December 5, 2024

Status Verified

December 1, 2024

Enrollment Period

1 year

First QC Date

August 29, 2024

Last Update Submit

December 3, 2024

Conditions

Keywords

chronic painmeditation

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

EXPERIMENTAL

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

Yoga Nidra and Pain Acceptance Intention

ACTIVE COMPARATOR

Yoga Nidra plus a Pain Acceptance Intention.

Other: Yoga Nidra with Pain Acceptance Intention

Yoga Nidra with Pain Acceptance Intervention and Motor Imagery

ACTIVE COMPARATOR

Yoga Nidra plus pain acceptance and motor imagery

Other: Yoga Nidra with Pain Acceptance Intervention and Motor Imagery

Interventions

This protocol is derived from The Origin and Clinical Relevance of Yoga Nidra (Pandi-Perumal, S. R. 2022)

Yoga Nidra

Yoga Nidra with Pain Acceptance Intention

Yoga Nidra and Pain Acceptance Intention

Yoga Nidra with Pain Acceptance Intervention and Motor Imagery

Yoga Nidra with Pain Acceptance Intervention and Motor Imagery

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Abigail Anderson, PT, DPT, PhD

    University of Central Florida

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Abigail Anderson, PT, DPT, PhD

CONTACT

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

Locations