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CompletedNCT07025161Updated Jul 30, 2026

Brief Mindfulness Intervention for Patients at a Free Acute Care Clinic

An interventional study of Pain Coping Information and Mindful Pain Management in Pain, sponsored by Florida State University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-30.

Sponsored by Florida State University · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
111
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This is a single-site, two-arm, parallel-group randomized clinical trial (RCT). The clinical effects of a 4-minute audio-recorded mindfulness intervention for 100 English-speaking patients and 100 Spanish-speaking patients at a free acute care clinic will be investigated relative to a 4-minute audio-recoding about pain psychoeducation.

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Conditions studied

  • Pain

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In context

Pain

2,219 studies on the registry are indexed under Pain; 915 are open to participants now.

This study's enrollment of 111 is above the median of 70 across 1,901 interventional studies indexed under Pain.

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Lead sponsor

Florida State University is the lead sponsor of 241 studies on the registry; 46 are open to participants now.

Of its 15 completed or terminated interventional studies of FDA-regulated products, 9 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Age ≥18
  • Seeking treatment at the Shepherd's Hope Downtown Clinic

Exclusion criteria

Exclusion Criteria:

  • Cognitive impairment preventing completion of study procedures.
  • Other unstable illness judged by medical staff to interfere with study involvement.
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
111 participants (actual)

Study arms

  • Active comparator
    Pain Coping Information

    Participants will be randomized to listen to a 4-minute audio recording providing common pain coping techniques (e.g., ice, rest, medication, surgery).

    Behavioral: Pain Coping Information

  • Experimental
    Mindful Pain Management

    Participants will be randomized to listen to a 4-minute audio recording consisting of a 1-minute introduction to mindfulness followed by a 1-minute and 30-second mindful breathing practice and a 1-minute and 30-second mindfulness of pain practice.

    Behavioral: Mindful Pain Management

Interventions

  • BehavioralPain Coping Information

    A 4-minute audio recording providing common pain coping techniques (e.g., ice, rest, medication, surgery).

  • BehavioralMindful Pain Management

    A 4-minute audio recording consisting of a 1-minute introduction to mindfulness followed by a 1-minute and 30-second mindful breathing practice and a 1-minute and 30-second mindfulness of pain practice.

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What researchers measure

Primary outcomes

  1. Change in Pain Unpleasantness Numeric Rating Scale

    Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most unpleasant pain imaginable.

    Time frame: Immediately before to after 4-minute audio recording

Secondary outcomes

  1. Change in Pain Intensity Numeric Rating Scale

    Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most intense pain imaginable.

    Time frame: Immediately before to after 4-minute audio recording

  2. Change in Anxiety Numeric Rating Scale

    Single Likert scale item ranging from 0-10, with 0 indicating no anxiety and 10 representing severe anxiety.

    Time frame: Immediately before to after 4-minute audio recording

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Study locations

1 site
  • Shepherd's Hope Downtown Clinic
    Orlando, Florida 32805, United States
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References and documents

Individual participant data

Plan to share: No — All our data is aggregate and anonymous.

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07025161
Lead sponsor
Florida State University
Responsible party
Adam Hanley (Principal Investigator, Florida State University) — Principal investigator
First posted
Jun 17, 2025
Start date
Apr 21, 2025
Primary completion
Dec 3, 2025
Completion
Dec 3, 2025
Last update
Jul 30, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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