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Does Choice Improve the Pain Relief Derived From a Brief Intervention

Brief (<10 Minute) Behavioral Interventions for Pain

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06582758
Enrollment
212
Registered
2024-09-03
Start date
2024-09-04
Completion date
2024-11-25
Last updated
2025-03-21

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

Conditions

Pain, Acute Pain

Keywords

mindfulness

Brief summary

This project is a single-site, four-arm, randomized controlled trial investigating whether providing patients in an orthopedic clinic waiting room the ability to choose which pain management intervention the receive impacts the degree of pain relief they experience.

Detailed description

This project is a single-site, four-arm, randomized controlled trial investigating whether providing patients in an orthopedic clinic waiting room the ability to choose which pain management intervention the receive impacts the degree of pain relief they experience. Participants will be randomized to one of three conditions: 1) a 4-minute pain psychoeducation recording, 2) a 4-minute mindfulness recording, or 3) choice. In the choice condition, participants will be able to choose which recoding (i.e., pain psychoeducation or mindfulness) they would like to listen to.

Interventions

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

In the mindful pain management intervention, participants will listen to a four minute mindfulness intervention consisting of a 1-minute introduction to mindful pain management and a 3-minute mindfulness practice.

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
Yes

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 7 to 10-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 7 to 10-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 7 to 10-minute audio recordingChange in anxiety from baseline will be assessed with the Generalized Anxiety Disorder 2-item. Scores range from 0 to 6, with higher scores reflecting greater anxiety.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026