Pain Relief Intervention of Meditation in Renal Disease (PRIMER)

Chronic Kidney Diseases Clinical Trial

— PRIMER  

Official title:

Pain Relief Intervention of Meditation in Renal Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03161197
• Other study ID #: 1503016044
• Status: Completed
• Phase: N/A
• Start date: April 24, 2015
• Est. completion date: June 30, 2017

Study information

• Verified date: October 2018
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Chronic Kidney Failure
• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Disease
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Behavioral:
• Mindfulness-Based Stress Reduction
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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in Pain: Participants self-report	Participants self-report	6 months

External Links

•   The Translational Research Institute for Pain in Later Life (TRIPLL) is an NIA funded Edward R. Roybal center with a focus on chronic pain