Kidney StoneMEDITATENCT06783946
Meditation Effects on Discomfort, Pain InTerference, and AnxieTy After urEteroscopy
A study testing Meditation in people with Kidney Stone and Pain, Postoperative, run by Children's Hospital of Philadelphia at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Kidney Stone, Pain, Postoperative, Anxiety Postoperative
- What is being tested?
- Meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Dec 2024to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: The Effect of Meditation on Anxiety and Pain of Patients Undergoing Ureteroscopy for Kidney Stones: A Pilot Randomized Study
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)?
Read more
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
Read the 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.
- Conditions
- Kidney Stone, Pain, Postoperative, Anxiety Postoperative
- Being tested
- Meditation
- Keywords
- Meditation, Post-Operative Pain, Ureteroscopy, Kidney Stones
- Medical subject headings
- Kidney Calculi, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeditationBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
The secondary outcome is the change in PROMIS T-scores from pre-operatively to post-operative day 30 in the domains of pain intensity, pain interference, anxiety, and depression. Four PROMIS questionnaires will be used, one per domain. They will be administered electronically with computerized adaptive testing, where responses guide subsequent item selection from the question bank. Thus, there is not a set number of questions per respondent. Each questionnaire typically consists of 4-12 items and can be completed under 1 minute. Each questionnaire results in a standardized T-Score (50 is the mean for a general reference population, 10 is the standard deviation). A higher T-score represents more of the concept being measures (e.g. worse 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. The trend of mean PROMIS T-Scores over the peri-operative period in both groups will be assessed.
Measured: Pre-operative baseline to 1 month post-operatively
Change in PROMIS Scores from Pre-Operatively to Post-Operative Day 30 (Pain Interference)
The secondary outcome is the change in PROMIS T-scores from pre-operatively to post-operative day 30 in the domains of pain intensity, pain interference, anxiety, and depression. Four PROMIS questionnaires will be used, one per domain. They will be administered electronically with computerized adaptive testing, where responses guide subsequent item selection from the question bank. Thus, there is not a set number of questions per respondent. Each questionnaire typically consists of 4-12 items and can be completed under 1 minute. Each questionnaire results in a standardized T-Score (50 is the mean for a general reference population, 10 is the standard deviation). A higher T-score represents more of the concept being measures (e.g. worse 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. The trend of mean PROMIS T-Scores over the peri-operative period in both groups will be assessed.
Measured: Pre-operative baseline to 1 month post-operatively
Change in PROMIS Scores from Pre-Operatively to Post-Operative Day 30 (Anxiety)
The secondary outcome is the change in PROMIS T-scores from pre-operatively to post-operative day 30 in the domains of pain intensity, pain interference, anxiety, and depression. Four PROMIS questionnaires will be used, one per domain. They will be administered electronically with computerized adaptive testing, where responses guide subsequent item selection from the question bank. Thus, there is not a set number of questions per respondent. Each questionnaire typically consists of 4-12 items and can be completed under 1 minute. Each questionnaire results in a standardized T-Score (50 is the mean for a general reference population, 10 is the standard deviation). A higher T-score represents more of the concept being measures (e.g. worse 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. The trend of mean PROMIS T-Scores over the peri-operative period in both groups will be assessed.
Measured: Pre-operative baseline to 1 month post-operatively
Change in PROMIS Scores from Pre-Operatively to Post-Operative Day 30 (Depression)
The secondary outcome is the change in PROMIS T-scores from pre-operatively to post-operative day 30 in the domains of pain intensity, pain interference, anxiety, and depression. Four PROMIS questionnaires will be used, one per domain. They will be administered electronically with computerized adaptive testing, where responses guide subsequent item selection from the question bank. Thus, there is not a set number of questions per respondent. Each questionnaire typically consists of 4-12 items and can be completed under 1 minute. Each questionnaire results in a standardized T-Score (50 is the mean for a general reference population, 10 is the standard deviation). A higher T-score represents more of the concept being measures (e.g. worse 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. The trend of mean PROMIS T-Scores over the peri-operative period in both groups will be assessed.
Measured: Pre-operative baseline to 1 month post-operatively
Feasibility Outcome: Monthly Proportion of Enrolled to Eligible Participants
Measures of feasibility of implementation of a perioperative meditation intervention in patients undergoing elective unilateral ureteroscopy for ureteral or renal stones. This will include evaluating the proportion of enrolled to eligible participants per month, reported using descriptive statistics. Monthly enrollment proportions will be presented, along with the overall mean and range for the entire study enrollment period.
Measured: Pre-operative baseline to 1 month post-operatively
Feasibility Outcome: Completion of Questionnaires
Measures of feasibility for implementing a perioperative meditation intervention in patients undergoing elective unilateral ureteroscopy for ureteral or renal stones will be assessed. This includes evaluating the proportion of PROMIS questionnaires completed at each time point, reported as the mean proportion of completed questionnaires to total eligible questionnaires, separated by group and by time point (baseline, post-operative days 3, 14, and 30).
Measured: Pre-operative baseline to 1 month post-operatively
Feasibility Outcome: Meditation Adherence
Measures of feasibility for implementing a perioperative meditation intervention in patients undergoing elective unilateral ureteroscopy for ureteral or renal stones will include evaluating meditation session adherence. Participants in the intervention arm will complete daily online logs indicating whether meditation was performed (yes/no). Adherence will be calculated as the proportion of meditation days marked "yes" to the total eligible meditation days. Results will be summarized using descriptive statistics, including mean, median, and mode.
Measured: Pre-operative baseline to 1 month post-operatively
Number of Participants Who Sought Unplanned Medical Attention
The number of participants seeking unplanned medical attention within 1 month post-operatively (including emergency department visits, unplanned office visits, unplanned surgical re-treatment, and phone calls) will be assessed through chart review and health care utilization questionnaires on post-operative days 14 and 30. Results will be reported as the mean number of unplanned medical events per participant.
Measured: Pre-operative baseline to 1 month post-operatively
Medication usage
A 2-item questionnaire will be administered to assess post-operative medication usage at post-operative days 3, 14, and 30. This will include:
- Has the participant taken any of these medications since surgery? Please select all medications at apply.
- Which of these medications is the participant currently taking? Please select all that apply.
Medication options include a variety of over the counter and prescription medications typically prescribed after stone surgery.
Number and type of medications taken will be assessed at each time point.
Measured: From surgery to post-operative day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start2 Dec 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney StoneStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania
- Responsible party
- Sponsor
- Investigators
- Gregory E Tasian, MD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06783946
- Sponsor's protocol ID
- 24-022475
- Acronym
- MEDITATE
- Status last verified
- Dec 2025
- First submitted
- 15 Jan 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Meditation on Anxiety and Pain of Patients Undergoing Ureteroscopy for Kidney Stones: A Pilot Randomized Study
- ClinicalTrials.gov ID
- NCT06783946
- Acronym / sponsor ID
- MEDITATE / 24-022475
- Conditions
- Kidney Stone, Pain, Postoperative, Anxiety Postoperative
- Keywords
- Meditation, Post-Operative Pain, Ureteroscopy, Kidney Stones
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- University of Pennsylvania
- Study start
- 2 Dec 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 20 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Meditation | Experimental | Behavioral: MeditationIn 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. |
| 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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MeditationThe 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. | Behavioural | Meditation |
Primary outcome
Change in PROMIS Scores from Pre-Operatively to Post-Operative Day 3 (Pain Intensity)
Time frame: Pre-operative baseline to post-operative day 3
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.
Change in PROMIS Scores from Pre-Operatively to Post-Operative Day 3 (Pain Interference)
Time frame: Pre-operative baseline to post-operative day 3
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.
Change in PROMIS Scores from Pre-Operatively to Post-Operative Day 3 (Anxiety)
Time frame: Pre-operative baseline to post-operative day 3
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.
Change in PROMIS Scores from Pre-Operatively to Post-Operative Day 3 (Depression)
Time frame: Pre-operative baseline to post-operative day 3
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.
9 secondary outcomes
Change in PROMIS Scores from Pre-Operatively to Post-Operative Day 30 (Pain Intensity)
Time frame: Pre-operative baseline to 1 month post-operatively
Change in PROMIS Scores from Pre-Operatively to Post-Operative Day 30 (Pain Interference)
Time frame: Pre-operative baseline to 1 month post-operatively
Change in PROMIS Scores from Pre-Operatively to Post-Operative Day 30 (Anxiety)
Time frame: Pre-operative baseline to 1 month post-operatively
Change in PROMIS Scores from Pre-Operatively to Post-Operative Day 30 (Depression)
Time frame: Pre-operative baseline to 1 month post-operatively
Feasibility Outcome: Monthly Proportion of Enrolled to Eligible Participants
Time frame: Pre-operative baseline to 1 month post-operatively
Feasibility Outcome: Completion of Questionnaires
Time frame: Pre-operative baseline to 1 month post-operatively
Feasibility Outcome: Meditation Adherence
Time frame: Pre-operative baseline to 1 month post-operatively
Number of Participants Who Sought Unplanned Medical Attention
Time frame: Pre-operative baseline to 1 month post-operatively
Medication usage
Time frame: From surgery to post-operative day 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Individual participant dataSharing planned: No
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Intertransverse Process Block Versus Erector Spinae Plane Block for Postoperative Analgesia After Percutaneous Nephrolithotomy
Kidney Stones, Urolithiasis, Hypocitraturia, Pain, Postoperative
Not yet recruiting
Comparison of Smart Pressure-Controlled Flexible Ureteroscopy and Flexible Suction Ureteral Access Sheath-Assisted Flexible Ureteroscopy for 2-3 cm Renal Stones
Kidney Stones
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gregory E Tasian, MD principal investigator
Children's Hospital of Philadelphia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meditation in people with Kidney Stone and Pain, Postoperative, run by Children's Hospital of Philadelphia at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.