5-minute Mindful Pain Management Strategy

NCT06394765 | Completed

• 1 other identifier: STUDY00005027
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Chronic Pain; Musculoskeletal Pain

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Treatment Acceptability

  Completed at 2- and 6-week follow-ups

• Global Impression of Change

  Completed at 2- and 6-week follow-ups

Other Outcomes (12)

• Acute Pain Unpleasantness

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

• Acute Pain Intensity

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

• Daily Pain Intensity

  Daily for 6 weeks

Study Arms (2)

Mindful Mapping

EXPERIMENTAL

Behavioral: Mindful Mapping

Serial Sevens

ACTIVE COMPARATOR

Behavioral: Serial Sevens

Interventions

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.

Mindful Mapping

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.

Serial Sevens

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• having learned to practice mindfulness meditation any time in the past
• being unable to perform most basic tasks due to pain or pain treatment

Sponsors & Collaborators

• Florida State University: lead

Study Sites (1)

Florida State University

Tallahassee, Florida, 32310, United States

Location

MeSH Terms

Conditions

Pain; Chronic Pain; Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be randomized (1:1) using a computer-generated randomization sequence created by the PI prior to the study start date.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 1, 2024
• Study Start: June 13, 2024
• Primary Completion: July 31, 2024
• Study Completion: September 15, 2024
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)