Skip to main content
OpenTrials
Completed

NCT Number: NCT06394765

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pain Chronic Pain Muscular Diseases Musculoskeletal Diseases Musculoskeletal Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Florida State University

Tallahassee, Florida, 32310, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindful Mapping

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Recruitment Feasibility

    Time frame: 3 months

    Examine recruitment rates during the 3 months planned for recruitment.

  2. Randomization Feasibility

    Time frame: 3 months

    Examine randomization rates during the 3 months planned for recruitment.

  3. Intervention Adherence

    Time frame: 5 minutes

    Examine the percentage of participants completing their 5-minute intervention session

  4. Therapeutic Skill Use Adherence

    Time frame: 2 weeks

    Examine the frequency of therapeutic skill use during the 2-week, post-intervention, self-management period.

Secondary outcomes

  1. Treatment Acceptability

    Time frame: 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.

  2. Global Impression of Change

    Time frame: 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.

Other outcomes

  1. Acute Pain Unpleasantness

    Time frame: Will be completed immediately before and after the 5-minute intervention session

    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.

  2. Acute Pain Intensity

    Time frame: Will be completed immediately before and after the 5-minute intervention session

    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.

  3. Daily Pain Intensity

    Time frame: Daily for 6 weeks

    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.

  4. Daily Pain Interference

    Time frame: Daily for 6 weeks

    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.

  5. Chronic Pain

    Time frame: Baseline, 2 weeks post-treatment, 6 week post-treatment

    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.

  6. Physical Function

    Time frame: Baseline, 2 weeks post-treatment, 6 week post-treatment

    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.

  7. Sleep

    Time frame: Baseline, 2 weeks post-treatment, 6 week post-treatment

    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.

  8. Pain Catastrophizing

    Time frame: Baseline, 2 weeks post-treatment, 6 week post-treatment

    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.

  9. Depression

    Time frame: Baseline, 2 weeks post-treatment, 6 week post-treatment

    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.

  10. Anxiety

    Time frame: Baseline, 2 weeks post-treatment, 6 week post-treatment

    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.

  11. Prescription Pain Medication Use

    Time frame: Baseline, 2 weeks post-treatment, 6 week post-treatment

    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.

  12. Mindful Pain Management

    Time frame: Baseline, 2 weeks post-treatment, 6 week post-treatment

    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.

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 1, 2024
Registry last updated
Mar 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.