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| Name | Class |
|---|---|
| University of Pennsylvania | OTHER |
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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregory E Tasian, MD | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States | ||
| University of Pennsylvania |
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| ID | Term |
|---|---|
| D007669 | Kidney Calculi |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D019122 | Meditation |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026443 | Spiritual Therapies |
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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.
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Urologic surgeons who will be performing the ureteroscopy will be masked to the group assignment
|
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 |
| 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. | 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. | 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. | 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. | 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). | 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. | 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. | 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:
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. | From surgery to post-operative day 30 |
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D012064 |
| Relaxation Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |