Meditation Effects on Discomfort, Pain InTerference, and AnxieTy After urEteroscopy

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Children's Hospital of Philadelphia
Study ID
NCT06783946
Status
Enrolling By Invitation

Conditions

  • Anxiety Postoperative
  • Kidney Stone
  • Pain, Postoperative

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Meditation — BEHAVIORAL
    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 completion of daily meditation practice electronically.

Study Details

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

Key Dates

Start date
Dec 2, 2024
Status verified
Dec 2025
Primary completion
Jun 30, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Meditation
    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.
  • No Intervention: Usual Care
    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.

Primary Outcome Measure

Change in PROMIS Scores from Pre-Operatively to Post-Operative Day 3 (Pain Intensity) [ Time Frame: Pre-operative baseline to post-operative day 3 ]

Locations (2)

FacilityCityStateZIPSite coordinators
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104-
University of PennsylvaniaPhiladelphiaPennsylvania19104-

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By research site
Children's Hospital of Philadelphia· Philadelphia, PAUniversity of Pennsylvania· Philadelphia, PA

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