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A Guided Meditation Program in Patients Undergoing Dialysis

Primary Purpose

End Stage Renal Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Relaxation and guided imagery program
Sponsored by
The Rogosin Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Rogosin Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Guided imagery

Arm Description

Relaxation and guided imagery program

Outcomes

Primary Outcome Measures

Quality of Life Score
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.
Anxiety level
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

Inflammation level
CRP laboratory test
Headaches
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).
Insomnia
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).
Fatigue
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).
Feeling pain
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).

Full Information

First Posted
February 11, 2019
Last Updated
April 4, 2023
Sponsor
The Rogosin Institute
Collaborators
Weill Medical College of Cornell University
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1. Study Identification

Unique Protocol Identification Number
NCT04155216
Brief Title
A Guided Meditation Program in Patients Undergoing Dialysis
Official Title
A Guided Meditation Program in Patients Undergoing Dialysis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
January 6, 2020 (Actual)
Primary Completion Date
October 7, 2020 (Actual)
Study Completion Date
October 7, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Rogosin Institute
Collaborators
Weill Medical College of Cornell University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Guided imagery
Arm Type
Experimental
Arm Description
Relaxation and guided imagery program
Intervention Type
Behavioral
Intervention Name(s)
Relaxation and guided imagery program
Intervention Description
Listening to a relaxation and guided imagery program for 25 minutes during hemodialysis treatments.
Primary Outcome Measure Information:
Title
Quality of Life Score
Description
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.
Time Frame
Four weeks
Title
Anxiety level
Description
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).
Time Frame
Four weeks
Secondary Outcome Measure Information:
Title
Inflammation level
Description
CRP laboratory test
Time Frame
Four weeks
Title
Headaches
Description
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).
Time Frame
Four weeks
Title
Insomnia
Description
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).
Time Frame
Four weeks
Title
Fatigue
Description
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).
Time Frame
Four weeks
Title
Feeling pain
Description
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).
Time Frame
Four weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males and females; 18 years or older. Receiving hemodialysis at The Rogosin Institute for End Stage Renal Disease. Willingness to adhere to the treatment intervention schedule. Subjects must present with anxiety. Willing and able to provide informed consent. Exclusion Criteria: Plans to withdraw from dialysis at The Rogosin Institute within the study timeline. Unable to provide informed consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Bohmart, MD
Organizational Affiliation
The Rogosin Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Rogosin Institute
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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A Guided Meditation Program in Patients Undergoing Dialysis

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