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Does Psychoeducation Improve the Pain Relief Derived From a Brief Intervention

Does Psychoeducation Improve the Pain Relief Derived From a Brief Mindfulness-Based Intervention Delivered in a Clinic Waiting Room

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06952049
Enrollment
646
Registered
2025-04-30
Start date
2025-04-10
Completion date
2025-12-18
Last updated
2026-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Acute Pain

Brief summary

This project is a single-site, five-arm, randomized controlled trial investigating whether providing patients in an orthopedic clinic waiting room psychoeducation about mindfulness impacts the degree of pain relief they experience during a mindfulness-based intervention.

Interventions

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

BEHAVIORALMindfulness without Psychoeducation

In the mindfulness without psychoeducation intervention, participants will be randomized to listen to a three-minute mindfulness practice consisting of 1 minute of mindful breathing, 1 minute of mindful mapping, and 1 minute of mindfulness of personal meaning.

BEHAVIORAL1 Minute Psychoeducation with 2 Minutes of Mindfulness (Pain Focus)

In the 1 Minute Psychoeducation with 2 minutes of Mindfulness (Pain Focus) intervention, participants will be randomized to listen to a 1 minute of psychoeducation about mindfulness, 1 minute of mindful breathing and 1 minute of mindful mapping.

BEHAVIORAL1 Minute Psychoeducation with 2 Minutes of Mindfulness (Meaning Focus)

In the 1 Minute Psychoeducation with 2 minutes of Mindfulness (Meaning Focus) intervention, participants will be randomized to listen to a 1 minute of psychoeducation about mindfulness, 1 minute of mindful breathing and 1 minute of mindfulness of personal meaning.

BEHAVIORAL2 Minutes of Psychoeducation with 1 Minute of Mindfulness

In the 2 Minutes of Psychoeducation with 1 Minute of Mindfulness intervention, participants will be randomized to listen to a 2 minute of psychoeducation about mindfulness and 1 minute of mindful breathing.

Sponsors

Florida State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Unable to consent because of physical or mental incapacity.

Design outcomes

Primary

MeasureTime frameDescription
Change in Pain Unpleasantness Numeric Rating ScaleImmediately before to after 3-minute audio recordingChange 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.

Secondary

MeasureTime frameDescription
Change in Pain Intensity Numeric Rating ScaleImmediately before to after 3-minute audio recordingChange in acute pain intensity will be measured with an individual item ("How much pain do you have, right now?") rated on a numeric rating scale. Scores range from 0 to 10, with higher scores reflecting greater acute pain intensity.
Change in Anxiety Numeric Rating ScaleImmediately before to after 3-minute audio recordingChange in anxiety from baseline will be assessed a single item adapted from the Generalized Anxiety Disorder-2. Scores range from 0 to 10, with higher scores reflecting greater anxiety.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026