Meditation for Recovery After Kidney Stone Surgery

(MEDITATE Trial)

Recruiting at 1 trial location

Overseen by Gregory E Tasian, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Children's Hospital of Philadelphia

No Placebo Group

Trial Summary

What is the purpose of this trial?

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

Research Team

Gregory E Tasian, MD

Principal Investigator

Children's Hospital of Philadelphia

Eligibility Criteria

This trial is for children and adults scheduled for kidney stone surgery (ureteroscopy) who are interested in trying meditation as part of their recovery process. Participants must be willing to complete health forms, pain and mood questionnaires before and after surgery, and practice daily meditation if assigned to that group.

Inclusion Criteria

I am scheduled for a kidney or ureter stone removal surgery in 2+ weeks.

Parental/guardian permission (informed consent) and if appropriate, child assent.

I am 12 years old or older.

Exclusion Criteria

Parents/guardians or subjects who, in the opinion of the investigator, may be non-compliant with study schedules or procedures

I do not have a working email or phone.

I am under 12 years old.

Treatment Details

Interventions

• Meditation (Behavioral Intervention)

Trial Overview The study is testing whether a daily 20-minute meditation program for 2-4 weeks before and 2 weeks after ureteroscopy can improve postoperative pain and anxiety. It will also assess the feasibility of patients adhering to this meditation routine around the time of their surgery.

Participant Groups

Group I: Meditation Experimental Treatment 1 Intervention

In the intervention group, a meditation intervention will be implemented pre- and post-operatively. The meditation technique will be comprised of breathing techniques, full body relaxation, color meditation, visualization, and positive affirmations. A physician researcher trained in teaching meditation will conduct virtual meditation sessions with patients enrolled in the study. Participants will practice a daily 20-minute meditation for 2-4 weeks before scheduled surgery (whichever is the maximum length of time from enrollment) to 2 weeks post-operatively using the provided audio guided meditation recordings. Participants will also log adherence to meditation via daily questionnaires. They will receive standard pre-operative counseling and post-operative medications at the discretion of their urologist.

Group II: Usual Care Active Control 1 Intervention

Those in the control or usual care arm will complete the same questionnaires at baseline and at post-operative days 3, 14, and 30. They will receive standard pre-operative counseling and post-operative medications at the discretion of their urologist.

Who Is Running the Clinical Trial?

Children's Hospital of Philadelphia

Lead Sponsor

Trials

749

Recruited

11,400,000+

University of Pennsylvania

Collaborator

Trials

2,118

Recruited

45,270,000+