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A Guided Meditation Program in Patients Undergoing Dialysis

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ClinicalTrials.gov Identifier: NCT04155216
Recruitment Status : Recruiting
First Posted : November 7, 2019
Last Update Posted : September 1, 2020
Sponsor:
Collaborator:
Weill Medical College of Cornell University
Information provided by (Responsible Party):
The Rogosin Institute

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.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Behavioral: Relaxation and guided imagery program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Guided Meditation Program in Patients Undergoing Dialysis
Actual Study Start Date : January 6, 2020
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Guided imagery
Relaxation and guided imagery program
Behavioral: Relaxation and guided imagery program
Listening to a relaxation and guided imagery program for 25 minutes during hemodialysis treatments.




Primary Outcome Measures :
  1. Quality of Life Score [ Time Frame: Four weeks ]
    To determine the quality of life using the Kidney Disease and Quality of Life (KDQOL) questionnaire. The score is determined by transforming the raw precoded numeric values of items to a 0-100 possible range, with higher transformed scores always reflecting better quality of life. Each item is put on a 0-100 range so that the lowest and highest possible score are set at 0 and 100 respectively. Scores represent the percentage of total possible score achieved.

  2. Anxiety level [ Time Frame: Four weeks ]
    To determine how much of an impact anxiety had on the subject's day to day life, using a Likert Scale, ranging from 1 (none) to 5 (extreme).


Secondary Outcome Measures :
  1. Inflammation level [ Time Frame: Four weeks ]
    CRP laboratory test

  2. Headaches [ Time Frame: Four weeks ]
    To determine how much of an impact headaches had on the subject's day to day life, using a Likert Scale, ranging from 1 (none) to 5 (extreme).

  3. Insomnia [ Time Frame: Four weeks ]
    To determine how much of an impact insomnia had on the subject's day to day life, using a Likert Scale, ranging from 1 (none) to 5 (extreme).

  4. Fatigue [ Time Frame: Four weeks ]
    To determine how much of an impact fatigue had on the subject's day to day life, using a Likert Scale, ranging from 1 (none) to 5 (extreme).

  5. Feeling pain [ Time Frame: Four weeks ]
    To determine how much of an impact pain had on the subject's day to day life, using a Likert Scale, ranging from 1 (none) to 5 (extreme).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04155216


Contacts
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Contact: Andrew Bohmart, MD 212-746-1559 anb9090@nyp.org

Locations
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United States, New York
The Rogosin Institute Recruiting
New York, New York, United States, 10021
Contact: Andrew Bohmart, MD    212-746-1559    anb9090@nyp.org   
Principal Investigator: Andrew Bohmart, MD         
Sponsors and Collaborators
The Rogosin Institute
Weill Medical College of Cornell University
Investigators
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Principal Investigator: Andrew Bohmart, MD The Rogosin Institute
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Responsible Party: The Rogosin Institute
ClinicalTrials.gov Identifier: NCT04155216    
Other Study ID Numbers: 1706018340
First Posted: November 7, 2019    Key Record Dates
Last Update Posted: September 1, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency