5-minute Mindful Pain Management Strategy

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.

Study Overview

• Status: Completed
• Conditions: Pain; Musculoskeletal Pain; Chronic Pain
• Intervention / Treatment: Behavioral: Mindful Mapping; Behavioral: Serial Sevens

Detailed Description

This was a two-arm (Mindful Mapping vs. Serial Sevens), remotely delivered, parallel-group, pilot RCT. All procedures were approval by the local IRB and preregistered (NCT06394765). Written informed consent was obtained from all participants prior to their inclusion in the study. Participants were randomly assigned (1:1) to either the Mindful Mapping intervention (n=30) or a control condition, Serial Sevens (n=30). Randomization was performed using a computer-generated sequence.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tallahassee, Florida, United States, 32310
      • Florida State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindful Mapping	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.
Active Comparator: Serial Sevens	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment Feasibility	Examine recruitment rates during the 3 months planned for recruitment.	3 months
Randomization Feasibility	Examine randomization rates during the 3 months planned for recruitment.	3 months
Intervention Adherence	Examine the percentage of participants completing their 5-minute intervention session	5 minutes
Therapeutic Skill Use Adherence	Examine the frequency of therapeutic skill use during the 2-week, post-intervention, self-management period.	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Florida State University

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2024
• Primary Completion (Actual): July 31, 2024
• Study Completion (Actual): September 15, 2024

Study Registration Dates

• First Submitted: April 29, 2024
• First Submitted That Met QC Criteria: April 29, 2024
• First Posted (Actual): May 1, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 18, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Musculoskeletal Pain; Chronic Pain
• Other Study ID Numbers: STUDY00005027

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No