5-minute Mindful Pain Management Strategy

Pain Clinical Trial

Official title:

5-minute Mindful Pain Management Strategy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06394765
• Other study ID #: STUDY00005027
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: November 1, 2025

Study information

• Verified date: June 2024
• Source: Florida State University
• Contact: Adam W Hanley, PhD
• Phone: 850-508-0286
• Email: adam.hanley[@]fsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This project is a single-site, two-arm, pilot study assessing the feasibility and preliminary efficacy of a 5-minute Mindful Mapping intervention for adults with chronic musculoskeletal pain (n=60) relative to a time- and attention-matched control condition.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 1, 2025
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• having a chronic pain diagnosis

• being able not to commit to another (new) treatment during the course of the study

• understanding English instructions fluently

• Being 18 and above

Exclusion Criteria:

• having learned to practice mindfulness meditation any time in the past

• being unable to perform most basic tasks due to pain or pain treatment

Related Conditions & MeSH terms

• Chronic Pain
• Musculoskeletal Pain
• Pain

Intervention

Behavioral:
• Mindful Mapping
Participants in the Mindful Mapping condition will receive a 5-minute, therapist-guided mindfulness intervention for chronic pain. During this training they will learn the 30-second Mindful Mapping technique, which they will be instructed to use each time they experience a painful sensation over the next 2 weeks. The Mindful Mapping technique consists of focusing on five basic characteristics (shape, weight, density, temperature, movement) of the most intense sensation in the body as it emerges in the present moment while remaining equanimous, i.e., preventing the learned reaction.
• Serial Sevens
Participants in the control condition will receive a 5-minute, therapist-guided "serial sevens" intervention for chronic pain. During this training, participants will be instructed that each time they experience pain, they will count backwards in their heads by 7 from 100 for 30 second.

Locations

Country	Name	City	State
United States	Florida State University	Tallahassee	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Florida State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Acute Pain Unpleasantness	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.	Will be completed immediately before and after the 5-minute intervention session
Other	Acute Pain Intensity	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.	Will be completed immediately before and after the 5-minute intervention session
Other	Daily Pain Intensity	Change in daily pain intensity from from the first post-intervention day through the 6-week follow-up will be assessed with the pain intensity item from the Pain, Enjoyment, and General Activity scale. Scores range from 0 to 10, with higher scores reflecting greater pain intensity.	Daily for 6 weeks
Other	Daily Pain Interference	Change in daily pain interference from from the first post-intervention day through the 6-week follow-up will be assessed with the two pain interference items from the Pain, Enjoyment, and General Activity scale. Scores range from 0 to 10, with higher scores reflecting greater pain interference.	Daily for 6 weeks
Other	Chronic Pain	Change in chronic pain from baseline through 6-week follow-up will be assessed with the Pain, Enjoyment, and General Activity scale. Scores range from 0 to 10, with higher scores reflecting greater chronic pain.	Baseline, 2 weeks post-treatment, 6 week post-treatment
Other	Physical Function	Change in physical function from baseline through 6-week follow-up will be assessed with the PROMIS Physical Functioning Short Form. Scores range from 6 to 30, with higher scores reflecting greater physical function.	Baseline, 2 weeks post-treatment, 6 week post-treatment
Other	Sleep	Change in sleep from baseline through 6-week follow-up will be assessed with the PROMIS Sleep Disturbance Short Form. Scores range from 6 to 30, with higher scores reflecting worse sleep.	Baseline, 2 weeks post-treatment, 6 week post-treatment
Other	Pain Catastrophizing	Change in pain catastrophizing from baseline through 6-week follow-up will be assessed with the Pain Catastrophizing Scale. Scores range from 0 to 52, with higher scores reflecting greater pain catastrophizing.	Baseline, 2 weeks post-treatment, 6 week post-treatment
Other	Depression	Change in depression from baseline through 6-week follow-up will be assessed with the Patient Health Questionnaire-2. Scores range from 0 to 6, with higher scores reflecting greater depression.	Baseline, 2 weeks post-treatment, 6 week post-treatment
Other	Anxiety	Change in anxiety from baseline through 6-week follow-up will be assessed with the Generalized Anxiety Disorder 2-item. Scores range from 0 to 6, with higher scores reflecting greater anxiety.	Baseline, 2 weeks post-treatment, 6 week post-treatment
Other	Prescription Pain Medication Use	Change in prescription pain medication misuse from baseline through 6-week follow-up will be assessed with the PROMIS Prescription Pain Medication Misuse Short Form. Scores range from 7 to 35, with higher scores reflecting greater medication misuse.	Baseline, 2 weeks post-treatment, 6 week post-treatment
Other	Mindful Pain Management	Change in the use of mindfulness for pain management from baseline through 6-week follow-up will be assessed with the Mindful Reappraisal of Pain Scale. Scores range from 0 to 54, with higher scores reflecting greater mindful pain management.	Baseline, 2 weeks post-treatment, 6 week post-treatment
Primary	Recruitment Feasibility	Examine recruitment rates during the 3 months planned for recruitment.	3 months
Primary	Randomization Feasibility	Examine randomization rates during the 3 months planned for recruitment.	3 months
Primary	Intervention Adherence	Examine the percentage of participants completing their 5-minute intervention session	5 minutes
Primary	Therapeutic Skill Use Adherence	Examine the frequency of therapeutic skill use during the 2-week, post-intervention, self-management period.	2 weeks
Secondary	Treatment Acceptability	Treatment acceptability will be assessed with the Treatment Acceptability and Preference (TAP) scale. Scores range from 0 to 4, with higher scores reflecting greater acceptability.	Completed at 2- and 6-week follow-ups
Secondary	Global Impression of Change	Treatment related improvement will be assessed with the Patient Global Impression of Change scale. Scores range from 0 to 7, with higher scores reflecting greater treatment related improvement.	Completed at 2- and 6-week follow-ups