Pain Relief Intervention of Meditation in Renal Disease (PRIMER)

NCT03161197 | Completed

• 1 other identifier: 1503016044
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

CKD, Dialysis, ESRD; Mindfulness-Based Stress Reduction (MBSR)

Outcome Measures

Primary Outcomes (1)

• Reduction in Pain: Participants self-report

  Participants self-report

  6 months

Study Arms (1)

Intervention

EXPERIMENTAL

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).

Behavioral: Mindfulness-Based Stress Reduction

Interventions

Mindfulness-Based Stress Reduction 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).

Also known as: MBSR

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Related 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

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Kidney Diseases; Kidney Failure, Chronic

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Renal Insufficiency; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Carla Boutin-Foster, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 4, 2017
• First Posted: May 19, 2017
• Study Start: April 24, 2015
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: October 29, 2018

Record last verified: 2018-10