Clinical trial NCT06394765: 5-minute Mindful Pain Management Strategy
Official title: 5-minute Mindful Pain Management Strategy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Chronic Pain
Musculoskeletal Pain
Lead sponsor: Florida State University
Sponsor class: OTHER
First posted: 2024-05-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 relative to a time- and attention-matched control condition.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Recruitment Feasibility
timeFrame: 3 months
measure: Randomization Feasibility
timeFrame: 3 months
measure: Intervention Adherence
timeFrame: 5 minutes
measure: Therapeutic Skill Use Adherence
timeFrame: 2 weeks
Secondary outcomes:
measure: Treatment Acceptability
timeFrame: Completed at 2- and 6-week follow-ups
measure: Global Impression of Change
timeFrame: Completed at 2- and 6-week follow-ups
Other outcomes:
measure: Acute Pain Unpleasantness
timeFrame: Will be completed immediately before and after the 5-minute intervention session
measure: Acute Pain Intensity
timeFrame: Will be completed immediately before and after the 5-minute intervention session
measure: Daily Pain Intensity
timeFrame: Daily for 6 weeks
measure: Daily Pain Interference
timeFrame: Daily for 6 weeks
measure: Chronic Pain
timeFrame: Baseline, 2 weeks post-treatment, 6 week post-treatment
measure: Physical Function
timeFrame: Baseline, 2 weeks post-treatment, 6 week post-treatment
measure: Sleep
timeFrame: Baseline, 2 weeks post-treatment, 6 week post-treatment
measure: Pain Catastrophizing
timeFrame: Baseline, 2 weeks post-treatment, 6 week post-treatment
measure: Depression
timeFrame: Baseline, 2 weeks post-treatment, 6 week post-treatment
measure: Anxiety
timeFrame: Baseline, 2 weeks post-treatment, 6 week post-treatment
measure: Prescription Pain Medication Use
timeFrame: Baseline, 2 weeks post-treatment, 6 week post-treatment
measure: Mindful Pain Management
timeFrame: Baseline, 2 weeks post-treatment, 6 week post-treatment
Locations:
city: Tallahassee
country: United States
facility: Florida State University
state: Florida
Study officials:
References: