Clinical trial NCT03161197: Pain Relief Intervention of Meditation in Renal Disease (PRIMER)
Official title: Pain Relief Intervention of Meditation in Renal Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Diseases
Renal Disease
Chronic Kidney Failure
End Stage Renal Disease
Keywords: CKD, Dialysis, ESRD
Mindfulness-Based Stress Reduction (MBSR)
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2017-05-19
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Reduction in Pain: Participants self-report
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Weill Medical College of Cornell University
name: Carla Boutin-Foster, MD
role: PRINCIPAL_INVESTIGATOR
References: