End Stage Renal DiseaseNCT04155216
A Guided Meditation Program in Patients Undergoing Dialysis
A study testing Relaxation and guided imagery program in people with End Stage Renal Disease, run by The Rogosin Institute at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- Relaxation and guided imagery program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2020to 7 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Plans to withdraw from dialysis at The Rogosin Institute within the study timeline.
- Unable to provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Relaxation and guided imagery program
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relaxation and guided imagery programBehavioural
Listening to a relaxation and guided imagery program for 25 minutes during hemodialysis treatments.
| Study group | Role | What they receive |
|---|---|---|
| Guided imagery | Experimental | Relaxation and guided imagery program Receives: Behavioral: Relaxation and guided imagery program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Four weeks
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).
Measured: Four weeks
Secondary outcomes (5)
Inflammation level
CRP laboratory test
Measured: Four weeks
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).
Measured: Four weeks
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).
Measured: Four weeks
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).
Measured: Four weeks
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).
Measured: Four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start6 Jan 2020
- Primary completion7 Oct 2020
- Study completion7 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Rogosin Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Weill Medical College of Cornell University
- Responsible party
- Sponsor
- Investigators
- Andrew Bohmart, MD, Principal investigator, The Rogosin Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04155216
- Sponsor's protocol ID
- 1706018340
- Status last verified
- Mar 2024
- First submitted
- 11 Feb 2019
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Guided Meditation Program in Patients Undergoing Dialysis
- ClinicalTrials.gov ID
- NCT04155216
- Acronym / sponsor ID
- 1706018340
- Conditions
- End Stage Renal Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- The Rogosin InstituteUniversity, hospital or other
- Collaborators
- Weill Medical College of Cornell University
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 7 Oct 2020 (actual)
- Study completion
- 7 Oct 2020 (actual)
- First posted
- 7 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Guided imagery | Experimental | Behavioral: Relaxation and guided imagery programRelaxation and guided imagery program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Plans to withdraw from dialysis at The Rogosin Institute within the study timeline.
- Unable to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relaxation and guided imagery programListening to a relaxation and guided imagery program for 25 minutes during hemodialysis treatments. | Behavioural | Guided imagery |
Primary outcome
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.
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).
5 secondary outcomes
Inflammation level
Time frame: Four weeks
Headaches
Time frame: Four weeks
Insomnia
Time frame: Four weeks
Fatigue
Time frame: Four weeks
Feeling pain
Time frame: Four weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Bohmart, MD principal investigator
The Rogosin Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relaxation and guided imagery program in people with End Stage Renal Disease, run by The Rogosin Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life Score (time frame: Four weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024; AzTrials last refreshed its copy on 3 Nov 2026.