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Pain Relief Intervention of Meditation in Renal Disease (PRIMER) (PRIMER)

Primary Purpose

Chronic Kidney Diseases, Renal Disease, Chronic Kidney Failure

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mindfulness-Based Stress Reduction
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Kidney Diseases focused on measuring CKD, Dialysis, ESRD, Mindfulness-Based Stress Reduction (MBSR)

Eligibility Criteria

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

Inclusion Criteria:

  • Patients with Chronic Kidney Disease (CKD) and ESRD on dialysis for over 6 months and who are willing to consent. English speakers only, 18 years of age or older

Exclusion Criteria:

  • Patients with severe cognitive or psychiatric impairment will be excluded. Patients who are not willing to provide consent.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Intervention

    Arm Description

    The intervention consists of 8-10 sessions consisting of mindfulness-based stress reduction. Key components of what the intervention consists relate to stress management, breathing, and meditation exercises, as well as, techniques aimed at improving relations with others, sense of mastery and purpose in life. Additionally, during every point of contact subjects will be asked how often they utilized the strategies they were taught. This information will be helpful in understanding each subject's individual level of mastery and proficiency in Mindfulness-Based Stress Reduction (MBSR).

    Outcomes

    Primary Outcome Measures

    Reduction in Pain: Participants self-report
    Participants self-report

    Secondary Outcome Measures

    Full Information

    First Posted
    May 4, 2017
    Last Updated
    October 26, 2018
    Sponsor
    Weill Medical College of Cornell University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03161197
    Brief Title
    Pain Relief Intervention of Meditation in Renal Disease (PRIMER)
    Acronym
    PRIMER
    Official Title
    Pain Relief Intervention of Meditation in Renal Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    April 24, 2015 (Actual)
    Primary Completion Date
    June 30, 2017 (Actual)
    Study Completion Date
    June 30, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Weill Medical College of Cornell 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
    Kidney Disease subjects will be recruited to take part of a mindfulness-based stress reduction intervention for 8-10 sessions. All subjects will complete a baseline interview, one follow-up at 3 months and the close out interview at 5 months.
    Detailed Description
    Kidney Disease subjects will be recruited from multiple locations within the Rogosin Institute Dialysis Center to take part of a mindfulness-based stress reduction intervention. The intervention consists of meet with a researcher and/or research assistant on a weekly basis. Dialysis patients will receive the intervention individually while on dialysis. Dialysis is an optimal time for conducting interventions as patients are there for 3-4 hours every 3 days. For 8-10 weeks (which will begin the week after the baseline interview). Chronic Kidney Disease (CKD) patients will receive the intervention in group setting. Key components of what the intervention consists relate to stress management, breathing, and meditation exercises, as well as, techniques aimed at improving relations with others, sense of mastery and purpose in life. Additionally, during every point of contact, will be asked how often they utilized the strategies they were taught. This information will be helpful in understanding each person's individual level of mastery and proficiency in Mindfulness-Based Stress Reduction (MBSR). All subjects will complete a baseline interview, one follow-up at 3 months and the close out interview at 5 months.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Kidney Diseases, Renal Disease, Chronic Kidney Failure, End Stage Renal Disease
    Keywords
    CKD, Dialysis, ESRD, Mindfulness-Based Stress Reduction (MBSR)

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Dialysis patients will receive the intervention individually while on dialysis. Dialysis is an optimal time for conducting interventions as patients are there for 3-4 hours every 3 days. For 8-10 weeks (which will begin the week after the baseline interview). Chronic Kidney Disease (CKD) patients will receive the intervention in group setting. Since CKD patients only come to see their nephrologist once a month, all CKD potential participants will be invited to attend eight consecutive weekly sessions.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    24 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    The intervention consists of 8-10 sessions consisting of mindfulness-based stress reduction. Key components of what the intervention consists relate to stress management, breathing, and meditation exercises, as well as, techniques aimed at improving relations with others, sense of mastery and purpose in life. Additionally, during every point of contact subjects will be asked how often they utilized the strategies they were taught. This information will be helpful in understanding each subject's individual level of mastery and proficiency in Mindfulness-Based Stress Reduction (MBSR).
    Intervention Type
    Behavioral
    Intervention Name(s)
    Mindfulness-Based Stress Reduction
    Other Intervention Name(s)
    MBSR
    Intervention Description
    The intervention consists of mindfulness-based stress reduction. Key components of what the intervention consists relate to stress management, breathing, and meditation, as well as, techniques aimed at improving relations with others, sense of mastery and purpose in life. Additionally, the intervention subjects, during every point of contact, will be asked how often they utilized the strategies they were taught. This information will be helpful in understanding each subject's individual level of mastery and proficiency in Mindfulness-Based Stress Reduction (MBSR).
    Primary Outcome Measure Information:
    Title
    Reduction in Pain: Participants self-report
    Description
    Participants self-report
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with Chronic Kidney Disease (CKD) and ESRD on dialysis for over 6 months and who are willing to consent. English speakers only, 18 years of age or older Exclusion Criteria: Patients with severe cognitive or psychiatric impairment will be excluded. Patients who are not willing to provide consent.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Carla Boutin-Foster, MD
    Organizational Affiliation
    Weill Medical College of Cornell University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    Undecided
    Links:
    URL
    http://tripll.org/
    Description
    The Translational Research Institute for Pain in Later Life (TRIPLL) is an NIA funded Edward R. Roybal center with a focus on chronic pain

    Learn more about this trial

    Pain Relief Intervention of Meditation in Renal Disease (PRIMER)

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