NCT07335159

Brief Summary

This project is a single-site, two-arm, randomized controlled trial investigating whether providing patients in an orthopedic clinic waiting room an audio-recorded mindfulness practice decreases their pain relative to an injury management control condition.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for not_applicable pain

Timeline
1mo left

Started Jan 2026

Shorter than P25 for not_applicable pain

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

Study Progress85%
Jan 2026May 2026

First Submitted

Initial submission to the registry

January 5, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

January 5, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 13, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2026

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

5 months

First QC Date

January 5, 2026

Last Update Submit

March 27, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Pain Unpleasantness Numeric Rating Scale

    Change in acute pain unpleasantness will be measured with an individual item ("How unpleasant is your pain, right now?") rated on a numeric rating scale. Scores range from 0 to 10, with higher scores reflecting greater acute pain unpleasantness.

    Immediately before to after 4-minute audio recording

Secondary Outcomes (1)

  • Change in Pain Intensity Numeric Rating Scale

    Immediately before to after 4-minute audio recording

Other Outcomes (2)

  • Interest in additional pain management resources

    Immediately after the 4-minute audio recording

  • Net Promoter Scale

    Immediately after the 4-minute audio recording

Study Arms (2)

Pain Psychoeducation

ACTIVE COMPARATOR

In the pain psychoeducation intervention, participants will be randomized to listen to a four-minute recording about different pain management strategies (e.g., ice, rest) to promote overall well-being.

Behavioral: Pain Psychoeducation

Mindfulness

EXPERIMENTAL

In the mindfulness intervention, participants will be randomized to listen to 1 minute of psychoeducation about mindfulness that includes a patient testimonial, 1 minute of mindful breathing, 1 minute of mindful mapping (i.e., mindfulness of pain), and 1 minute of mindfulness of personal meaning.

Behavioral: Mindfulness

Interventions

In the pain psychoeducation intervention, participants will be randomized to listen to a four-minute recording about different pain management strategies (e.g., ice, rest) to promote overall well-being.

Pain Psychoeducation
MindfulnessBEHAVIORAL

In the mindfulness intervention, participants will be randomized to listen to 1 minute of psychoeducation about mindfulness that includes a patient testimonial, 1 minute of mindful breathing, 1 minute of mindful mapping (i.e., mindfulness of pain), and 1 minute of mindfulness of personal meaning.

Mindfulness

Eligibility Criteria

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

You may qualify if:

  • Receiving treatment at Tallahassee Orthopedic Center
  • Understanding English instructions fluently
  • Being 18 years of age or older

You may not qualify if:

  • Unable to consent because of physical or mental incapacity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tallahassee Orthopedic Clinic

Tallahassee, Florida, 32308, United States

RECRUITING

MeSH Terms

Conditions

PainAcute PainChronic PainAgnosia

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

Carter Minnick

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 5, 2026

First Posted

January 13, 2026

Study Start

January 5, 2026

Primary Completion (Estimated)

May 30, 2026

Study Completion (Estimated)

May 30, 2026

Last Updated

March 30, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations