Does Patient Testimonial Improve the Pain Relief Derived From a Brief Intervention
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFlorida State University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Receiving treatment at Tallahassee Orthopedic Center
Understanding English instructions fluently
Being 18 years of age or older
Disqualifiers
Unable to consent because of physical or mental incapacity.
Trial design
Design model
Parallel
Treatments tested in this trial
Pain Psychoeducation
BehavioralIn 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.
Mindfulness
BehavioralIn 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.
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: Pain PsychoeducationActive comparator 1 intervention
Group B: MindfulnessExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Immediately before to after 4-minute audio recordingSecondary outcomes
1
Change in Pain Intensity Numeric Rating Scale
Change 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.
Time frame
Immediately before to after 4-minute audio recordingOther outcomes
1
Interest in additional pain management resources
After the recording, participants will complete a single dichotomous (yes/no) item assessing interest in additional pain management resources: "Would you like access to additional pain management resources similar to the one presented today?"
Time frame
Immediately after the 4-minute audio recording2
Net Promoter Scale
The Net Promoter Scale (NPS) is a single-item measure of satisfaction and loyalty that asks respondents to rate how likely they are to recommend a product, service, or experience to others, typically on an 11-point scale from 0 ("not at all likely") to 10 ("extremely likely"). Responses are categorized as detractors (0-6), passives (7-8), or promoters (9-10). The overall NPS score is calculated by subtracting the percentage of detractors from the percentage of promoters, yielding a score ranging from -100 to +100.
Time frame
Immediately after the 4-minute audio recordingSponsors and contacts
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Source ClinicalTrials.gov