Pain Relief Intervention of Meditation in Renal Disease (PRIMER)

NCT ID: NCT03161197

Last Updated: 2018-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-24
• Study Completion Date: 2017-06-30

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.

Conditions

Chronic Kidney Diseases; Renal Disease; Chronic Kidney Failure; End Stage Renal Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention

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).

Group Type: EXPERIMENTAL

Mindfulness-Based Stress Reduction

Intervention Type: BEHAVIORAL

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).

Interventions

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).

Intervention Type: BEHAVIORAL

Other Intervention Names

MBSR

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carla Boutin-Foster, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Related Links

http://tripll.org/

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

Other Identifiers

1503016044

Identifier Type: -

Identifier Source: org_study_id