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Mindful Walking for Adults With Chronic Pain

Primary Purpose

Chronic Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mindful Walking for Adults with Chronic Pain
Sponsored by
Clemson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Individuals 18 years of age or older Residents in Oconee and Pickens County Individuals with mild to severe chronic pain (i.e., neuropathic pain, postoperative pain, migraine headaches, etc.) Individuals must be able to read and understand English (can speak other languages), a translator will not be provided. Exclusion Criteria: Current Mindfulness practice. Individuals without chronic pain. Individuals who cannot walk without assistance for more than 5 minutes. Individuals who do not experience mild to severe chronic pain for at least 3 days per week every week on average.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Mindful Walking

    Arm Description

    All participants will belong to the experimental mindful walking arm for our single arm feasibility study.

    Outcomes

    Primary Outcome Measures

    Pain Intensity
    Measure participants perceived level of pain using validated scales Brief Pain Inventory for pain level 0 meaning no pain and 10 meaning pain as bad as you can imagine.
    Unpleasantness of the pain
    Understand participants perceived level of pain using questionnaire Brief Pain Inventory for pain level 0 meaning no pain and 10 meaning pain as bad as you can imagine and qualitative responses.
    Pain-related functional scale
    Measure participants perceived level of pain using validated scales for pain level (Visual Pain scale 0 meaning no pain and 10 being the worst pain.
    Pain-related quality of life
    Understand participants perceived level of pain using validated scales for pain level (Visual Pain scale Pain scale 0 meaning no pain and 10 being the worst pain. Also use qualitative data responses.

    Secondary Outcome Measures

    Mindfulness inventory
    Assess the effect of mindfulness techniques based on survey questions and qualitative responses.
    Perceived intervention effectiveness of pain change
    Perceived intervention effectiveness of pain change will be assessed with a Visual Analogue Scale (VAS) ("0" = not effective at all; "10"= most effective imaginable, for each intervention session's assigned intervention

    Full Information

    First Posted
    October 4, 2023
    Last Updated
    October 18, 2023
    Sponsor
    Clemson University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06088329
    Brief Title
    Mindful Walking for Adults With Chronic Pain
    Official Title
    Mindfulness Walking for Adults With Chronic Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 24, 2023 (Anticipated)
    Primary Completion Date
    December 5, 2023 (Anticipated)
    Study Completion Date
    December 19, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Clemson University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Both mindfulness-based interventions and light physical activity have been shown as effective in reducing the burden of chronic pain. This proposed intervention, mindful walking (MW), is a combination of physical activity and mindfulness-based intervention aimed at reducing pain with a non-pharmacological approach. In MW, mindfulness-based instructions emphasized acknowledging arising thoughts, feelings, and/or emotions without judgment or emotional reaction and to "simply return their attention back to the footstep" sensation whenever such discursive events occur. Furthermore, subjects will be taught that perceived sensory and affective events were "momentary" and "fleeting" and do not require further interpretation or evaluation.
    Detailed Description
    Specifically, our proposed MW intervention will focus on the following: Participants will be instructed to focus on the sensations occurring "at the toes or at sole." Participants will be instructed to expand their focus to the "full length of the step," including bodily sensations (e.g., rise and fall of the abdomen and chest). Participants will learn the application of mindfulness principles with the goal for use in everyday life. The anticipation is to include thirty patients in Clemson South Carolina with chronic pain without any prior meditative experience (diabetes patients with neuropathic pain, prostate cancer patients with postoperative pain, etc.) into our study. Eligible participants will then complete 6 sessions of mindful walking across 6 weeks. Each weekly session will last approximately 60 minutes and will be conducted outdoors (weather pending). Mindful walking is a practice of becoming aware of one's surroundings and internal feelings while moving. When practicing walking mindfully, one focuses his/her attention on the sensations in the body with each step, paying close attention to the breath. The mindful walking sessions are intended to provide therapeutic techniques based on achieving a state of mind that focuses one's awareness on the present moment while acknowledging and accepting one's thoughts/feelings. Sessions will be led by a certified instructor to follow mindfulness practices with the incorporation of walking for adults with chronic pain. At the end of the sessions, participants will be randomly selected using a random number generator to participate in an informal interview session. This is an opportunity for participants to tell us about their experiences in the program and how mindful walking has impacted their chronic pain. The interview will take about thirty minutes of their time.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Pain

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    15 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Mindful Walking
    Arm Type
    Experimental
    Arm Description
    All participants will belong to the experimental mindful walking arm for our single arm feasibility study.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Mindful Walking for Adults with Chronic Pain
    Intervention Description
    Participants identified with chronic pain will complete 6 sessions of mindfulness based walking exercises.
    Primary Outcome Measure Information:
    Title
    Pain Intensity
    Description
    Measure participants perceived level of pain using validated scales Brief Pain Inventory for pain level 0 meaning no pain and 10 meaning pain as bad as you can imagine.
    Time Frame
    Over a 6 week time frame from the start at baseline of the study (week 0) to the end of the study (week 6).
    Title
    Unpleasantness of the pain
    Description
    Understand participants perceived level of pain using questionnaire Brief Pain Inventory for pain level 0 meaning no pain and 10 meaning pain as bad as you can imagine and qualitative responses.
    Time Frame
    Over a 6 week time frame from the start at baseline of the study (week 0) to the end of the study (week 6).
    Title
    Pain-related functional scale
    Description
    Measure participants perceived level of pain using validated scales for pain level (Visual Pain scale 0 meaning no pain and 10 being the worst pain.
    Time Frame
    Over a 6 week time frame from the start at baseline of the study (week 0) to the end of the study (week 6).
    Title
    Pain-related quality of life
    Description
    Understand participants perceived level of pain using validated scales for pain level (Visual Pain scale Pain scale 0 meaning no pain and 10 being the worst pain. Also use qualitative data responses.
    Time Frame
    Over a 6 week time frame from the start at baseline of the study (week 0) to the end of the study (week 6).
    Secondary Outcome Measure Information:
    Title
    Mindfulness inventory
    Description
    Assess the effect of mindfulness techniques based on survey questions and qualitative responses.
    Time Frame
    Over a 6 week time frame from the start at baseline of the study (week 0) to the end of the study (week 6).
    Title
    Perceived intervention effectiveness of pain change
    Description
    Perceived intervention effectiveness of pain change will be assessed with a Visual Analogue Scale (VAS) ("0" = not effective at all; "10"= most effective imaginable, for each intervention session's assigned intervention
    Time Frame
    Over a 6 week time frame from the start at baseline of the study (week 0) to the end of the study (week 6).

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Individuals 18 years of age or older Residents in Oconee and Pickens County Individuals with mild to severe chronic pain (i.e., neuropathic pain, postoperative pain, migraine headaches, etc.) Individuals must be able to read and understand English (can speak other languages), a translator will not be provided. Exclusion Criteria: Current Mindfulness practice. Individuals without chronic pain. Individuals who cannot walk without assistance for more than 5 minutes. Individuals who do not experience mild to severe chronic pain for at least 3 days per week every week on average.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Principal Investigator
    Phone
    864-656-0495
    Email
    lus@clemson.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Project Organizer
    Phone
    864-986-4077
    Email
    kmegget@clemson.edu

    12. IPD Sharing Statement

    Learn more about this trial

    Mindful Walking for Adults With Chronic Pain

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