5-minute Mindful Pain Management Strategy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Florida State University
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Intervention Adherence
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
Participants will be randomized (1:1) using a computer-generated randomization sequence created by the PI prior to the study start date.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Intervention Adherence
Time Frame: 5 minutes
Examine the percentage of participants completing their 5-minute intervention session
Randomization Feasibility
Time Frame: 3 months
Examine randomization rates during the 3 months planned for recruitment.
Therapeutic Skill Use Adherence
Time Frame: 2 weeks
Examine the frequency of therapeutic skill use during the 2-week, post-intervention, self-management period.
Recruitment Feasibility
Time Frame: 3 months
Examine recruitment rates during the 3 months planned for recruitment.
Secondary Outcomes
- Treatment Acceptability(Completed at 2- and 6-week follow-ups)
- Global Impression of Change(Completed at 2- and 6-week follow-ups)
Investigators
Adam Hanley
Associate Professor
Florida State University