Meditation for Recovery After Kidney Stone Surgery

(MEDITATE Trial)

Enrolling by invitation 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether meditation can aid recovery from kidney stone surgery by reducing pain and anxiety. Participants will be divided into two groups: one will practice meditation techniques such as deep breathing and visualization before and after surgery, while the other will receive standard care. The trial seeks individuals aged 12 years or older who are scheduled for ureteroscopy, a specific type of kidney stone surgery. Those planning surgery for kidney stones may find this trial suitable. As an unphased trial, it offers a unique opportunity to explore innovative recovery methods that could enhance the surgical experience.

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 prior data suggests that meditation is safe for recovery after kidney stone surgery?

Research has shown that meditation is a safe and well-tolerated practice for people recovering from surgery. Studies have found that guided meditation can reduce pain and anxiety post-surgery. Participants who used guided meditation reported feeling less anxious and experiencing less pain. Meditation has also improved sleep quality, which aids recovery.

No known serious side effects are associated with meditation, making it a low-risk option. Meditation is widely accepted and often used for relaxation and stress management, making it a promising option for those seeking to support their recovery after kidney stone surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores meditation as a tool for recovery after kidney stone surgery, offering a non-pharmaceutical approach to managing post-operative healing. Unlike traditional treatments that rely on medications to alleviate pain and promote recovery, this meditation technique incorporates breathing exercises, full-body relaxation, and visualization. By engaging the mind and body, meditation may enhance recovery by reducing stress and potentially even pain, offering a holistic complement to standard surgical care. This trial could uncover how integrating mindfulness practices improves patient outcomes without the side effects associated with medications.

What evidence suggests that meditation might be an effective treatment for recovery after kidney stone surgery?

This trial will compare a meditation intervention with usual care for recovery after kidney stone surgery. Studies have shown that meditation can reduce anxiety and depression, particularly around the time of surgery. Research indicates that high anxiety before surgery often results in more pain afterward and a slower recovery. Meditation calms the mind, potentially leading to less pain and a quicker recovery. Some studies have found that mindfulness meditation significantly reduces anxiety and improves mood in surgical patients. Guided meditation, which includes techniques like breathing exercises and visualization, has been well-researched and supports a successful surgery experience. ^{6 7 8 9 10}

Who Is on the Research Team?

Gregory E Tasian, MD

Principal Investigator

Children's Hospital of Philadelphia

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. e-century.us e-century.us/files/ajtr/16/5/ajtr0153804.pdf

Investigation of the application of Enhanced Recovery After ... Abstract: Objective: To investigate the efficacy and application of Enhanced Recovery After Surgery (ERAS) in elderly.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2818773/

Mindfulness Meditation Training to Reduce Symptom ... This paper describes the design and rationale of a clinical trial to determine whether training in mindfulness meditation can reduce depression, anxiety and ...

3. headspace.com headspace.com/articles/meditation-and-recovery

Can meditation shorten recovery time after surgery? A significant number of studies suggest preoperative anxiety is associated with increased postoperative pain, slower recovery, increased risk of infection, and ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9246505/

Mindfulness for patients undergoing surgery: a cost-effective ... There is a wealth of Level I evidence that illustrates the ability of mindfulness to improve symptoms of anxiety and depression.

5. healingworksfoundation.org healingworksfoundation.org/guided-imagery/guided-meditations-to-promote-successful-surgery/

Guided Meditations To Promote Successful Surgery This award winning, highly researched meditation for surgery preparation and recovery, was found in double blind, placebo-controlled research.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11170615/

Investigation of the application of Enhanced Recovery After ... Objective: To investigate the efficacy and application of Enhanced Recovery After Surgery (ERAS) in elderly patients undergoing surgery for kidney stones.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03198039

Guided Meditation as an Adjunct to Enhance Postoperative ... In addition to testing feasibility, the investigators will explore whether a meditation program can affect recovery after surgery. Patients enrolled will be ...

8. patlynk.com patlynk.com/trial/NCT03198039

Guided Meditation as an Adjunct to Enhance Postoperative ... The primary purpose of this trial is to test the feasibility of implementing a meditation program in the perioperative period. This is a prospective, ...

9. examine.com examine.com/research-feed/study/z0Ae20/?srsltid=AfmBOorUx5TlLiLE8opfhkGfRja4waA1IgJDd6NxP8_RiLikMk3XTkDT

Guided meditation improves well-being after surgery The outcomes were anxiety, pain, sleep quality, nausea, and vomiting. The results. Participants who listened to guided imagery had less pain, anxiety, and ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11603705/

Mindfulness Meditation Reduces Stress and Hospital Stay ... Perioperative short-term mindfulness meditation can improve the mindfulness ability of patients with gastrointestinal tumors, relieve anxiety and tension, ...