Meditation Effects on Discomfort, Pain InTerference, and AnxieTy After urEteroscopy (NCT06783946) | Clinical Trial Compass
By InvitationNot Applicable
Meditation Effects on Discomfort, Pain InTerference, and AnxieTy After urEteroscopy
United States50 participantsStarted 2024-12-02
Plain-language summary
The goal of this pilot clinical trial is to learn whether meditation can help improve recovery in children and adults having surgery for kidney stones. The main questions it aims to answer are:
* Does meditation around the time of surgery improve pain and anxiety in patients undergoing kidney stone surgery (ureteroscopy)?
* Is a meditation program around the time of surgery feasible for patients having kidney stone surgery (ureteroscopy)?
Participants will be randomly assigned to the meditation group and the control group to understand how meditation affects recovery after surgery. Participants will be asked to:
* Complete a health history form
* Complete questionnaires about pain and mood before surgery and certain days after surgery
* Those in the meditation group will learn and practice a daily 20-minute meditation for 2-4 weeks before surgery and 2 weeks after surgery
* Those in the meditation group will be asked to provide feedback of the meditation program after completing the last questionnaire
Who can participate
Age range
12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subjects age 12 years and older
. Diagnosis of unilateral or bilateral ureteral or renal stones
. Scheduled to undergo elective unilateral ureteroscopy for renal or ureteral stones in 2 or more weeks from initial clinic visit
. Parental/guardian permission (informed consent) and if appropriate, child assent.
Exclusion criteria
. Participants \<12 years of age
. Subjects undergoing any other type of stone procedure (i.e. bilateral ureteroscopy, percutaneous nephrolithotomy, ESWL, staged ureteroscopy)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in PROMIS Scores from Pre-Operatively to Post-Operative Day 3 (Pain Intensity)
Timeframe: Pre-operative baseline to post-operative day 3
2
Change in PROMIS Scores from Pre-Operatively to Post-Operative Day 3 (Pain Interference)
Timeframe: Pre-operative baseline to post-operative day 3
3
Change in PROMIS Scores from Pre-Operatively to Post-Operative Day 3 (Anxiety)
Timeframe: Pre-operative baseline to post-operative day 3
4
Change in PROMIS Scores from Pre-Operatively to Post-Operative Day 3 (Depression)
Timeframe: Pre-operative baseline to post-operative day 3