Pain Relief Intervention of Meditation in Renal Disease (PRIMER)

Not Applicable

Completed

• Conditions: Chronic Kidney Failure; Chronic Kidney Diseases; Renal Disease; End Stage Renal Disease
• Interventions: Behavioral: Mindfulness-Based Stress Reduction

• Registration Number: NCT03161197
• Lead Sponsor: Weill Medical College of Cornell University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2015-04-24
• Study First Submitted: 2017-05-04
• Study First Submitted QC: 2017-05-18
• Study First Posted: 2017-05-19
• Primary Completion: 2017-06-30
• Study Completion: 2017-06-30
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-26
• Last Update Posted: 2018-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Mindfulness-Based Stress Reduction	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).

Primary Outcome Measures

Name	Time	Method
Reduction in Pain: Participants self-report	6 months	Participants self-report