A Guided Meditation Program in Patients Undergoing Dialysis

NCT ID: NCT04155216

Last Updated: 2024-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-06
• Study Completion Date: 2020-10-07

Brief Summary

This is an open-label, single center, non-randomized, single-arm pilot study to determine the ability of a Relaxation and Guided Imagery Program for its ability to induce a reduction in anxiety in subjects undergoing hemodialysis for End Stage Renal Disease (ESRD). Measures will evaluate the program's ability to impact anxiety, with secondary analysis of headaches, insomnia, fatigue, and pain. Subjects will be administered questionnaires at the study start and study end. Intervention will involve listening to a pre-recorded guided relaxation and imagery during regularly-scheduled dialysis sessions for four weeks.

Detailed Description

The investigators hypothesize that participation in the guided relaxation and imagery sessions, at least once during each hemodialysis session by subjects presenting with anxiety, will result in a demonstrated ability to shift out of anxiety into a peaceful state of mind, and result in a decrease in the reported immediate and overall anxiety levels.

Intervention will involve listening to a pre-recorded guided relaxation and imagery during regularly-scheduled dialysis sessions for four weeks. Subjects will be asked to complete the Kidney Disease and Quality of Life (KDQOL) questionnaire relating to quality of life measures, Likert scales to measure anxiety, headaches, insomnia, fatigue and pain and a questionnaire to assess other practiced meditative therapies, psychological therapies and medications.

Study Procedures:

Baseline: Following consent, each subject will be given an introduction to the program and will be provided with an MP3 player, pre-loaded with a recording of the guided mediation program. Subjects will be asked to complete the KDQOL questionnaire, as well as a Likert Scale to measure the psychophysical parameters in question at baseline. Subjects will be given a short questionnaire to assess other practiced meditative therapies. Per standard of care, patients will have blood drawn to measure C Reactive Protein (CRP) levels on day of consent, or within one week prior to Visit 1.

Visits 1 - 12: Subjects will complete a Likert Scale at the start of every dialysis session for 4 weeks (a total of 12 sessions), as well as listen to the recording at least once during each of the 12 sessions. Every recorded session will last approximately 25 minutes. Subjects will repeat the Likert Scale completion following each recorded session.

Visit 12: Subjects will be asked to complete the KDQOL questionnaire and a short questionnaire to assess other practiced meditative therapies, psychological therapies, and medications. Subjects will have C reactive protein drawn as standard of care. The subject's medical record will be reviewed for data relevant to the study. This includes dialysis attendance, notes on study measures, including anxiety, as well as headaches, insomnia, fatigue, and pain, KDQOL results, and CRP levels.

Conditions

End Stage Renal Disease

Study Design

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

Study Groups

Guided imagery

Relaxation and guided imagery program

Group Type: EXPERIMENTAL

Relaxation and guided imagery program

Intervention Type: BEHAVIORAL

Listening to a relaxation and guided imagery program for 25 minutes during hemodialysis treatments.

Interventions

Relaxation and guided imagery program

Listening to a relaxation and guided imagery program for 25 minutes during hemodialysis treatments.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Males and females; 18 years or older.

2. Receiving hemodialysis at The Rogosin Institute for End Stage Renal Disease.

3. Willingness to adhere to the treatment intervention schedule.

4. Subjects must present with anxiety.

5. Willing and able to provide informed consent.

Exclusion Criteria

1. Plans to withdraw from dialysis at The Rogosin Institute within the study timeline.

2. Unable to provide informed consent.

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

Sponsors

Weill Medical College of Cornell University

OTHER

Sponsor Role: collaborator

The Rogosin Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew Bohmart, MD

Role: PRINCIPAL_INVESTIGATOR

The Rogosin Institute

Locations

The Rogosin Institute

New York, New York, United States

Countries

United States

Other Identifiers

1706018340

Identifier Type: -

Identifier Source: org_study_id