An interventional study of Relaxation and guided imagery program in End Stage Renal Disease, sponsored by The Rogosin Institute. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-15.
Sponsored by The Rogosin Institute · Not applicable, Interventional, and Treatment
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Among 765 studies in Kidney Failure, Chronic with a site in United States — 65 open to participants now, 97 under way, 9 of them phase 3. Kidney Failure, Chronic · United States.
Among the 765 studies in Kidney Failure, Chronic with a site in United States, this one is the 542nd largest by enrollment of the 638 interventional ones that give a count, is one of 35 that started in 2020, is one of 287 with no phase, and was the 544th registered.
2,109 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.
Browse Kidney Failure, Chronic studies →65 of the 765 studies in Kidney Failure, Chronic with a site in United States are open now. Recruiting first, the newest first:
United Therapeutics · Sites in United States
Ages 40–70
Xeno Holdings (US), LLC dba ChoironeX · Sites in United States
Ages 18–70
University of California, San Francisco · Sites in United States
Ages 18+
Basilea Pharmaceutica · Sites in United States
Ages 18–80 · Healthy volunteers
University of Washington · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 169 Kidney Failure, Chronic studies recruiting now, 109 (64%) set no upper age limit and 32 (19%) stop at 75 or younger; 18 take children under 18; 22 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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765 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 119 · Phase 2 130 · Phase 3 89 · Phase 4 61
First in 1995; this study’s year is marked. 35 started in 2020.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 10 is below the median of 57 across 1,569 interventional studies indexed under Kidney Failure, Chronic.
Median enrollment 48 across the 638 interventional studies, 100 across the 121 observational. Of the 610 that completed or were terminated, 267 (44%) have results posted.
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275 of 765 have an industry lead sponsor. The 10 most frequent:
The Rogosin Institute is the lead sponsor of 24 studies on the registry; 3 are open to participants now.
The Rogosin Institute has 6 studies filed under Kidney Failure, Chronic — fewer than ten, so there is no comparison to draw.
44 of the studies in Kidney Failure, Chronic with a site in United States that are under way reach primary completion within a year, 5 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04020055Phase 3Amicus TherapeuticsA Study to Evaluate Migalastat in Fabry Subjects With Amenable GLA Variant and Renal Disease | 2026-12-31 |
| NCT05931276Phase 3VA Office of Research and DevelopmentCSP #2026 - Beta Blocker Dialyzability on Cardiovascular Outcomes | 2026-12-31 |
| NCT03321656Phase 3Roberto GedalyImpact of Envarsus XR® on Kidney Biopsy Subclinical Rejection and Blood Immunologic Profile | 2027-03-31 |
| NCT05908084Phase 3Humacyte, Inc.To Compare the Efficacy and Safety of the ATEV With AVF in Female Patients With End-Stage Renal Disease Requiring Hemodialysis | 2027-06 |
| NCT05422534Phase 3Vanderbilt University Medical CenterCoQ10 and Exercise for Mitochondrial Dysfunction in Advance Kidney Disease | 2027-06-20 |
Add all 44 to your calendar (.ics) → With an account.
Among the 765 studies in Kidney Failure, Chronic with a site in United States, from their registry updates:
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: 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).
Time frame: Four weeks
Inflammation level
CRP laboratory test
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Four weeks
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2020 to primary completion in Oct 2020, 9 months.
Of 347 non-industry interventional studies with no phase under Kidney Failure, Chronic, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 47. This study's 9 months is below that.
Counting every sponsor, half of 425 studies reached it within 22 months; a quarter within 8 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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The Rogosin Institute