Meditation for Recovery After Kidney Stone Surgery

(MEDITATE Trial)

Recruiting at 1 trial location

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital of Philadelphia

Disqualifiers: Non-English, Neurologic comorbidities, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

50 Participants Needed

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

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on meditation as an additional practice around the time of surgery.

What data supports the effectiveness of the treatment Meditation for recovery after kidney stone surgery?

Research shows that meditation can help reduce stress, anxiety, and pain, which are common after surgeries like kidney stone removal. It has been beneficial for managing chronic pain and improving mood, suggesting it could aid in recovery by promoting relaxation and emotional well-being. ^{1 2 3 4 5}

Is meditation generally safe for humans?

Meditation is widely practiced by millions of people and is considered one of the most common forms of complementary medicine. While it is generally safe, some studies have reported possible side effects, mainly related to mental health. It's important for researchers to screen participants and follow safety guidelines to minimize risks. ^{3 4 6 7 8}

How does meditation differ from other treatments for recovery after kidney stone surgery?

Meditation is unique because it focuses on mental relaxation and stress reduction, which can improve emotional well-being and potentially enhance recovery after surgery, unlike traditional treatments that primarily address physical symptoms and complications. ^{9 10 11 12 13}

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Meditation

Participants in the meditation group practice daily 20-minute meditation for 2-4 weeks before surgery

2-4 weeks

Virtual meditation sessions

Surgery and Immediate Post-operative

Participants undergo ureteroscopy for kidney stones and complete PROMIS questionnaires at baseline and post-operative days 3, 14, and 30

1 month

In-person surgery, virtual follow-up

Post-operative Meditation

Participants in the meditation group continue daily 20-minute meditation for 2 weeks post-operatively

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including completion of PROMIS questionnaires and assessment of unplanned medical attention

1 month

Treatment Details

Interventions

• Meditation

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+

Findings from Research

Mindfulness meditation (MM) can have side effects, particularly related to mental health, physical health, and spiritual well-being, highlighting the need for safety considerations in research.

The paper provides practical tools for researchers, including screening procedures to assess participant contraindications and guidelines for MM training, based on a review of 17 primary studies and 5 secondary reports on meditation side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness meditation research: issues of participant screening, safety procedures, and researcher training. Lustyk, MK., Chawla, N., Nolan, RS., et al.[2022]

References

1. Korea (South) pubmed.ncbi.nlm.nih.gov

[The experiences of recovery from disease in patients doing meditation]. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Meditation's impact on chronic illness. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Factors Associated with the Use of Meditation, U.S. Adults 2017. [2020]

4. England pubmed.ncbi.nlm.nih.gov

The effect of a one-time 15-minute guided meditation (Isha Kriya) on stress and mood disturbances among operating room professionals: a prospective interventional pilot study. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Global Meditation Practices: A Literature Review. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Mindfulness meditation research: issues of participant screening, safety procedures, and researcher training. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Effect of Healing Meditation on Weight Loss and Waist Circumference of Overweight and Obese Women: Randomized Blinded Clinical Trial. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Effect of Healing Meditation on stress and eating behavior in overweight and obese women: A randomized clinical trial. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Complementary and Alternative Medicine Use in First-time and Recurrent Kidney Stone Formers. [2022]

10. Italy pubmed.ncbi.nlm.nih.gov

Translation and validation of the Chinese version of Wisconsin Stone Quality of Life questionnaire in patients with kidney stones. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Perioperative Fast-Track Surgery Nursing Intervention for Patients with Kidney Stone Disease under Computed Tomography Imaging. [2023]

12. Pakistan pubmed.ncbi.nlm.nih.gov

Complex renal calculi treated with traditional Chinese medicine Paishi decoction combined with laparoscopic ureterectomy. [2023]

13. Turkey pubmed.ncbi.nlm.nih.gov

Validation of the Turkish version of the Wisconsin stone-quality of life questionnaire. [2020]