Clinical trial NCT06783946: Meditation Effects on Discomfort, Pain InTerference, and AnxieTy After urEteroscopy
Official title: The Effect of Meditation on Anxiety and Pain of Patients Undergoing Ureteroscopy for Kidney Stones: A Pilot Randomized Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Kidney Stone
Pain, Postoperative
Anxiety Postoperative
Keywords: Meditation
Post-Operative Pain
Ureteroscopy
Kidney Stones
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
First posted: 2025-01-20
Enrollment: 50
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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

Detailed description: Context:

Pain is common after surgery to remove urinary stones, and current options for post-operative pain management are limited. Pre-operative anxiety is a well-known clinical entity that is associated with a higher risk of post-operative pain. Meditation is an ancient discipline that has been used for a wide range of presumed benefits including improving pain and anxiety. Meditation has been studied in a variety of clinical settings, but its effects have not been assessed among patients having ureteroscopy to remove kidney and/or ureteral stones.

Objectives:

To determine the effect of a peri-operative meditation intervention on physical and emotional health in adolescent and adult patients undergoing elective unilateral ureteroscopy for unilateral renal or ureteral stones.

To determine the feasibility of implementing a perioperative meditation intervention in patients undergoing elective unilateral ureteroscopy for ureteral or renal stones

Study Design:

Pilot randomized controlled trial

Setting/Participants:

This study will recruit 50 patients aged 12 years or older at the Children's Hospital of Philadelphia and University of Pennsylvania, who will be undergoing elective unilateral ureteroscopy for unilateral renal or ureteral stones with or without stent placement. Participants will be randomized to the meditation intervention or usual care treatment arms.

Intervention: Participants will be randomized to the intervention (meditation) or control groups. Participants will learn and 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 guide.

The Patient-Reported Outcomes Measurement Information System (PROMIS) instruments in the domains of Pain Intensity, Pain Interference, Anxiety, and Depression will be utilized. Patients will complete the questionnaire at the time of enrollment, and at post-operative days 3, 14, and 30. General information, health history, and kidney stone related events will be assessed from the medical record.

Eligibility criteria: Inclusion Criteria:

1. Subjects age 12 years and older
2. Diagnosis of unilateral or bilateral ureteral or renal stones
3. Scheduled to undergo elective unilateral ureteroscopy for renal or ureteral stones in 2 or more weeks from initial clinic visit
4. Parental/guardian permission (informed consent) and if appropriate, child assent.

Exclusion Criteria:

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

Primary outcomes:
measure: Change in PROMIS Scores from Pre-Operatively to Post-Operative Day 3 (Pain Intensity)
timeFrame: Pre-operative baseline to post-operative day 3
measure: Change in PROMIS Scores from Pre-Operatively to Post-Operative Day 3 (Pain Interference)
timeFrame: Pre-operative baseline to post-operative day 3
measure: Change in PROMIS Scores from Pre-Operatively to Post-Operative Day 3 (Anxiety)
timeFrame: Pre-operative baseline to post-operative day 3
measure: Change in PROMIS Scores from Pre-Operatively to Post-Operative Day 3 (Depression)
timeFrame: Pre-operative baseline to post-operative day 3
Secondary outcomes:
measure: Change in PROMIS Scores from Pre-Operatively to Post-Operative Day 30 (Pain Intensity)
timeFrame: Pre-operative baseline to 1 month post-operatively
measure: Change in PROMIS Scores from Pre-Operatively to Post-Operative Day 30 (Pain Interference)
timeFrame: Pre-operative baseline to 1 month post-operatively
measure: Change in PROMIS Scores from Pre-Operatively to Post-Operative Day 30 (Anxiety)
timeFrame: Pre-operative baseline to 1 month post-operatively
measure: Change in PROMIS Scores from Pre-Operatively to Post-Operative Day 30 (Depression)
timeFrame: Pre-operative baseline to 1 month post-operatively
measure: Feasibility Outcome: Monthly Proportion of Enrolled to Eligible Participants
timeFrame: Pre-operative baseline to 1 month post-operatively
measure: Feasibility Outcome: Completion of Questionnaires
timeFrame: Pre-operative baseline to 1 month post-operatively
measure: Feasibility Outcome: Meditation Adherence
timeFrame: Pre-operative baseline to 1 month post-operatively
measure: Number of Participants Who Sought Unplanned Medical Attention
timeFrame: Pre-operative baseline to 1 month post-operatively
measure: Medication usage
timeFrame: From surgery to post-operative day 30
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Gregory E Tasian, MD
role: PRINCIPAL_INVESTIGATOR
References: