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

NCT06783946 | Enrolling By Invitation

• 1 other identifier: 24-022475
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Anxiety Postoperative; Kidney Stone; Pain, Postoperative

Keywords

Meditation; Post-Operative Pain; Ureteroscopy; Kidney Stones

Outcome Measures

Primary Outcomes (4)

• Change in PROMIS Scores from Pre-Operatively to Post-Operative Day 3 (Pain Intensity)

  The primary outcome is the change in PROMIS T-scores from pre-operatively to post-operative day 3 in the domains of pain intensity, pain interference, anxiety, and depression. Four PROMIS questionnaires will be utilized, one for each domain. Questionnaires will be administered electronically with computerized adaptive testing (CAT). With CAT participants' responses guide the system's choice of subsequent items from the question bank; therefore, there is not a set number of questions per respondent. Each questionnaire will typically consist of 4-12 items and can be completed under 1 minute. Each questionnaire results in a standardized T-Score, in which 50 is the mean score for a general reference population, and 10 is the standard deviation. A higher PROMIS T-score represents more of the concept being measures (e.g. worse anxiety or pain intensity). Questionnaires will be administered at baseline and post-operative days 3, 14, 30 with separate T-scores for each time point and domain.

  Pre-operative baseline to post-operative day 3

• Change in PROMIS Scores from Pre-Operatively to Post-Operative Day 3 (Pain Interference)

  The primary outcome is the change in PROMIS T-scores from pre-operatively to post-operative day 3 in the domains of pain intensity, pain interference, anxiety, and depression. Four PROMIS questionnaires will be utilized, one for each domain. Questionnaires will be administered electronically with computerized adaptive testing (CAT). With CAT participants' responses guide the system's choice of subsequent items from the question bank; therefore, there is not a set number of questions per respondent. Each questionnaire will typically consist of 4-12 items and can be completed under 1 minute. Each questionnaire results in a standardized T-Score, in which 50 is the mean score for a general reference population, and 10 is the standard deviation. A higher PROMIS T-score represents more of the concept being measures (e.g. worse anxiety or pain intensity). Questionnaires will be administered at baseline and post-operative days 3, 14, 30 with separate T-scores for each time point and domain.

  Pre-operative baseline to post-operative day 3

• Change in PROMIS Scores from Pre-Operatively to Post-Operative Day 3 (Anxiety)

  The primary outcome is the change in PROMIS T-scores from pre-operatively to post-operative day 3 in the domains of pain intensity, pain interference, anxiety, and depression. Four PROMIS questionnaires will be utilized, one for each domain. Questionnaires will be administered electronically with computerized adaptive testing (CAT). With CAT participants' responses guide the system's choice of subsequent items from the question bank; therefore, there is not a set number of questions per respondent. Each questionnaire will typically consist of 4-12 items and can be completed under 1 minute. Each questionnaire results in a standardized T-Score, in which 50 is the mean score for a general reference population, and 10 is the standard deviation. A higher PROMIS T-score represents more of the concept being measures (e.g. worse anxiety or pain intensity). Questionnaires will be administered at baseline and post-operative days 3, 14, 30 with separate T-scores for each time point and domain.

  Pre-operative baseline to post-operative day 3

• Change in PROMIS Scores from Pre-Operatively to Post-Operative Day 3 (Depression)

  The primary outcome is the change in PROMIS T-scores from pre-operatively to post-operative day 3 in the domains of pain intensity, pain interference, anxiety, and depression. Four PROMIS questionnaires will be utilized, one for each domain. Questionnaires will be administered electronically with computerized adaptive testing (CAT). With CAT participants' responses guide the system's choice of subsequent items from the question bank; therefore, there is not a set number of questions per respondent. Each questionnaire will typically consist of 4-12 items and can be completed under 1 minute. Each questionnaire results in a standardized T-Score, in which 50 is the mean score for a general reference population, and 10 is the standard deviation. A higher PROMIS T-score represents more of the concept being measures (e.g. worse anxiety or pain intensity). Questionnaires will be administered at baseline and post-operative days 3, 14, 30 with separate T-scores for each time point and domain.

  Pre-operative baseline to post-operative day 3

Secondary Outcomes (9)

• Change in PROMIS Scores from Pre-Operatively to Post-Operative Day 30 (Pain Intensity)

  Pre-operative baseline to 1 month post-operatively

• Change in PROMIS Scores from Pre-Operatively to Post-Operative Day 30 (Pain Interference)

  Pre-operative baseline to 1 month post-operatively

• Change in PROMIS Scores from Pre-Operatively to Post-Operative Day 30 (Anxiety)

  Pre-operative baseline to 1 month post-operatively

• Change in PROMIS Scores from Pre-Operatively to Post-Operative Day 30 (Depression)

  Pre-operative baseline to 1 month post-operatively

• Feasibility Outcome: Monthly Proportion of Enrolled to Eligible Participants

  Pre-operative baseline to 1 month post-operatively

Study Arms (2)

Meditation

EXPERIMENTAL

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.

Behavioral: Meditation

Usual Care

NO 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.

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.

Meditation

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Participants \<12 years of age
• Subjects undergoing any other type of stone procedure (i.e. bilateral ureteroscopy, percutaneous nephrolithotomy, ESWL, staged ureteroscopy)
• Patients who are pre-stented at the initial clinic visit
• Non-English speaking participants
• Participants without functional e-mail address or phone
• Participants unable to use a computer/tablet independently
• Participants who will be undergoing ureteroscopy in less than 2 weeks from initial clinic visit
• Patients who are non-verbal or with cognitive delay that may impair ability to learn and adhere to intervention
• Patients with neurologic comorbidities that may alter sensation (eg. spinal cord injuries)
• Parents/guardians or subjects who, in the opinion of the investigator, may be non-compliant with study schedules or procedures

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• University of Pennsylvania: collaborator

Study Sites (2)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Kidney Calculi; Pain, Postoperative

Interventions

Meditation

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Gregory E Tasian, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Urologic surgeons who will be performing the ureteroscopy will be masked to the group assignment
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Block randomization, stratified by site, will be used to randomize participants into the treatment or control arms. Those in the treatment group will be taught a meditation intervention to be performed daily from 2-4 weeks before scheduled surgery date (whichever is the maximum length of time) to 2 weeks post-operatively. Participants will complete questionnaires to assess pain, anxiety, and depression at enrollment (day 0), post-operative days 3, 14, and 30. Participant feedback to assess experiences with the meditation intervention will be assessed within 1 month after completion of the final questionnaires.

Study Record Dates

• First Submitted: January 15, 2025
• First Posted: January 20, 2025
• Study Start: December 2, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)