5-minute Mindful Pain Management Strategy

NCT ID: NCT06394765

Last Updated: 2025-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-13

Study Completion Date

2024-09-15

Brief Summary

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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

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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.

Conditions

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Pain Chronic Pain Musculoskeletal Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Participants will be randomized (1:1) using a computer-generated randomization sequence created by the PI prior to the study start date.

Study Groups

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Mindful Mapping

Group Type EXPERIMENTAL

Mindful Mapping

Intervention Type 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

Group Type ACTIVE_COMPARATOR

Serial Sevens

Intervention Type 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.

Interventions

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Mindful Mapping

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.

Intervention Type BEHAVIORAL

Serial Sevens

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Florida State University

OTHER

Sponsor Role lead

Responsible Party

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Adam Hanley

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Florida State University

Tallahassee, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY00005027

Identifier Type: -

Identifier Source: org_study_id

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