5-minute Mindful Pain Management Strategy

Not Applicable

Completed

• Conditions: Chronic Pain; Pain; Musculoskeletal Pain
• Interventions: Behavioral: Serial Sevens; Behavioral: Mindful Mapping

• Registration Number: NCT06394765
• Lead Sponsor: Florida State University

Brief 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.

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 Timeline

• Study First Submitted: 2024-04-29
• Study First Submitted QC: 2024-04-29
• Study First Posted: 2024-05-01
• Study Start: 2024-06-13
• Primary Completion: 2024-07-31
• Study Completion: 2024-09-15
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Serial Sevens	Serial Sevens	-
Mindful Mapping	Mindful Mapping	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Treatment Acceptability	Completed at 2- and 6-week follow-ups	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.
Global Impression of Change	Completed at 2- and 6-week follow-ups	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.

Trial Locations

Locations (1)

Florida State University; 🇺🇸 Tallahassee, Florida, United States