Pediatric Kidney DiseaseNCT06858267
The Impact of Meditation on Anxiety and Post-Operative Pain in Pediatric Patients Undergoing Urological Surgery
A study testing PeSSKi questionnaire survey and Meditation Video in people with Pediatric Kidney Disease, run by Augusta University at 1 site in United States.
Trial summary
1. The aim of this study is to assess anxiety in pediatric patients preoperatively, perioperatively, and postoperatively and whether meditation reduces anxiety in the days before, during, and after the surgery. 2. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Pediatric Kidney Disease
- What is being tested?
- PeSSKi questionnaire survey and Meditation Video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2025to 30 Dec 2028
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 6-18
- Pediatric urology patients at Children's Healthcare of Georgia in Augusta, GA; scheduled for any urological surgery
- Otherwise, healthy patients
- Must record any medical history and medications
- Must record prior attempts of meditation therapy
- Children must provide assent
Who cannot join
- History of any prior surgeries
- History of anxiety or anxiety-related disorders
- Diagnosis of developmental delay
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Augusta University
Augusta, Georgia, 30912
Bradley Morganstern, MD, 706-721-0982, BMORGANSTERN@augusta.edu
Patty Ray, Phd Physioogy, 7067219680, PARAY@augusta.edu
About this study
- The aim of this study is to assess anxiety in pediatric patients preoperatively, perioperatively, and postoperatively and whether meditation reduces anxiety in the days before, during, and after the surgery.
- The second aim of this study is to see if longitudinal meditation is associated with decreased postoperative pain by examining whether the group prescribed meditation has reduced pain medication intake, measured by the frequency of liquid analgesic medicine intake.
Read the detailed description
Up to 70% of pediatric patients experience preoperative and perioperative anxiety. The anxiety level of their parents or guardians also affects the anxiety levels of pediatric patients themselves. Anxiety levels often peak during the time of anesthesia induction, suggesting the unfamiliar physical environment plays a role in increasing anxiety levels. Pediatric anxiety often manifests in various ways such as strong emotions, physical noncompliance, and regression. Pre-operative anxiety has been shown to increase the risk of cardiovascular events during the operation, increase difficulty gaining access to intubation, and increase anesthetic requirements. The effects of pre-operative anxiety do not end once the operation is complete. Rather, there have been suggestions that preoperative anxiety has a positive association with postoperative pain and prolonged hospital stay. Thirteen percent of pediatric surgical patients have postoperative pain that interferes with their daily activities or sleep patterns. In addition, 25-63% of pediatric patients who undergo urological surgeries experience moderate to severe pain on postoperative day 1 and the pain decreases but persists for 2 days on average. Therefore, it is worthwhile to explore noninvasive and adaptable methods to decrease preoperative anxiety among the patient and their guardians'.
Mindfulness is turning one's awareness of past and future events inward to focus on the present time. The practice provides an opportunity for people to reflect on their current internal conditions in a space and time that is not pressured, which can improve their ability to healthily and effectively respond to those conditions. One such study proposed that trait mindfulness and perceived anxiety have an inverse relationship. While another showed those with higher levels of trait mindfulness have increased resistance to stress and psychological flexibility. By embracing the entire spectrum of emotions one may encounter in the present or about a future event, people may be able to feel relief instead of increased anxiety or worry.
- Conditions
- Pediatric Kidney Disease
- Being tested
- PeSSKi questionnaire survey, Meditation Video
- Keywords
- The Impact of Meditation on Anxiety and Post-Operative Pain in Pediatric Patients Undergoing Urological Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PeSSKi questionnaire surveyBehavioural
The control group will only receive the questionnaire without meditation. The PeSSKi questionnaire survey will be receive in 4 time point, First questionnaire will sent via email after the appointment for the surgery is scheduled. The second PeSSKi questionnaire survey will share via email at halfway point to the surgery. The third questionnaire survey will be done immediately before the day of surgery in person to assess how anxious the patient is. The final questionnaire survey will be done 1 week postoperatively to assess how much pain the patient is still in after the quantity of analgesic usage logged throughout the week.
Meditation VideoBehavioural
The experimental group pediatric patients selected for this study and their parents will be receiving meditation and PeSSKi (Perceived Stress Scale for Kids) questionnaire. The ideal meditation schedule will be 3-5 meditations per week for 5 minutes beginning 3 weeks before surgery. This will provide a dose-response relationship of meditation to anxiety and postoperative pain for data analysis. The Patient and their parents will open the link, enter their assigned number, and follow the guided meditation embedded in the Qualtrics. This will track how many times and for how long the patients are following the regimen.
The questionnaire has eleven questions on a five-point scale ranging from "Not at all" to "A lot". An example of the meditation video questionnaire is linked here:
https://augusta.qualtrics.com/jfe/form/SV_3DeFFKdJVupMJQq (experimental group) https://augusta.qualtrics.com/jfe/form/SV_2b2DZ9x16jY9IzQ (PeSSKi questionnaire)
| Study group | Role | What they receive |
|---|---|---|
| 30 study subjects with meditation | Experimental | The meditation regimen will be linked in a Qualtrics that is delivered to them via email daily. The patient and their parents will open the link, enter their assigned number, and follow the guided meditation embedded in the Qualtrics. This will track how many times and for how long the patients are following the regimen.
The first PeSSKi (Perceived Stress Scale for Kids) questionnaire survey will be asked and sent via email after the appointment surgery is scheduled to assess anxiety. The second PeSSKi questionnaire survey will be over email at the halfway point to the surgery to see impact of meditation and anxiety levels at this point. The third questionnaire survey will be done immediately before the day of surgery in person to assess how anxious the patient is. The final questionnaire survey will be done 1 week postoperatively to assess the pain label of the patient is still in after the quantity of analgesic usage logged throughout the week. Receives: Behavioral: PeSSKi questionnaire survey; Behavioral: Meditation Video |
| 30 study subjects without meditation | Placebo comparator | The control group will only receive the questionnaire without meditation.
The first PeSSKi questionnaire survey will be asked and sent via email after the appointment where the surgery is scheduled to assess anxiety. The second PeSSKi questionnaire survey will be over email at the halfway point to the surgery to see the anxiety levels are at this point. The third questionnaire survey will be done immediately before the day of the surgery in person to assess how anxious the patient is. The final questionnaire survey will be done 1 week postoperatively to assess how much pain the patient is still in after the quantity of analgesic usage logged throughout the week. The questionnaire has eleven questions on a five-point scale ranging from "Not at all" to "A lot". The questionnaire link is given bellow:
https://augusta.qualtrics.com/jfe/form/SV_2b2DZ9x16jY9IzQ (PeSSKi questionnaire) The control group will receive just the PeSSKi questionnaire. Receives: Behavioral: PeSSKi questionnaire survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative Meditation may decrease preoperative anxiety among the patient and their guardians. And to see if longitudinal meditation is associated with decreased postoperative pain by examining frequency of liquid analgesic medicine intake.
Number of participants with meditation as assessed to change pain label from baseline in pain score on the scale at 1-week postoperative condition. The final questionnaire survey will be done 1 week postoperatively to assess how much pain the patient is still in after the quantity of analgesic usage logged throughout the week.
Measured: Active participation in the study will last for about one month, this includes three weeks pre-operatively and one week post-operatively. Total duration of the project is approximately two years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start1 Mar 2025 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Kidney DiseaseStudies of the same condition, open and under way.
- 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
- Pediatric patients between the ages of 6 to 18 who will be undergoing urological surgery will be selected for this study along with their parents. Recruitment will begin in the clinic after surgery is scheduled. The patients will be also sign an informed consent form and assent. Patients and parents will be divided into two groups receiving meditation and not receiving meditation. The ideal meditation schedule will be 3-5 meditations per week for 5 minutes beginning 3 weeks before surgery. This will provide a dose-response relationship of meditation to anxiety and postoperative pain for data analysis. For randomization, the patients and their parents will be assigned a number, surveyed at 4-time points, and given a meditation regimen to see how anxiety is affected. The meditation regimen will be linked in a Qualtrics. The control group will only receive the questionnaire without meditation. The survey has eleven questions on a five-point scale ranging from "Not at all" to "A lot"
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bradley Morganstern, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06858267
- Sponsor's protocol ID
- 2254633
- Status last verified
- Mar 2025
- First submitted
- 24 Feb 2025
- Last updated
- 7 Mar 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 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Meditation on Anxiety and Post-Operative Pain in Pediatric Patients Undergoing Urological Surgery
- ClinicalTrials.gov ID
- NCT06858267
- Acronym / sponsor ID
- 2254633
- Conditions
- Pediatric Kidney Disease
- Keywords
- The Impact of Meditation on Anxiety and Post-Operative Pain in Pediatric Patients Undergoing Urological Surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 5 Mar 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 aim of this study is to assess anxiety in pediatric patients preoperatively, perioperatively, and postoperatively and whether meditation reduces anxiety in the days before, during, and after the surgery.
- The second aim of this study is to see if longitudinal meditation is associated with decreased postoperative pain by examining whether the group prescribed meditation has reduced pain medication intake, measured by the frequency of liquid analgesic medicine intake.
Detailed description
Up to 70% of pediatric patients experience preoperative and perioperative anxiety. The anxiety level of their parents or guardians also affects the anxiety levels of pediatric patients themselves. Anxiety levels often peak during the time of anesthesia induction, suggesting the unfamiliar physical environment plays a role in increasing anxiety levels. Pediatric anxiety often manifests in various ways such as strong emotions, physical noncompliance, and regression. Pre-operative anxiety has been shown to increase the risk of cardiovascular events during the operation, increase difficulty gaining access to intubation, and increase anesthetic requirements. The effects of pre-operative anxiety do not end once the operation is complete. Rather, there have been suggestions that preoperative anxiety has a positive association with postoperative pain and prolonged hospital stay. Thirteen percent of pediatric surgical patients have postoperative pain that interferes with their daily activities or sleep patterns. In addition, 25-63% of pediatric patients who undergo urological surgeries experience moderate to severe pain on postoperative day 1 and the pain decreases but persists for 2 days on average. Therefore, it is worthwhile to explore noninvasive and adaptable methods to decrease preoperative anxiety among the patient and their guardians'.
Mindfulness is turning one's awareness of past and future events inward to focus on the present time. The practice provides an opportunity for people to reflect on their current internal conditions in a space and time that is not pressured, which can improve their ability to healthily and effectively respond to those conditions. One such study proposed that trait mindfulness and perceived anxiety have an inverse relationship. While another showed those with higher levels of trait mindfulness have increased resistance to stress and psychological flexibility. By embracing the entire spectrum of emotions one may encounter in the present or about a future event, people may be able to feel relief instead of increased anxiety or worry.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pediatric patients between the ages of 6 to 18 who will be undergoing urological surgery will be selected for this study along with their parents. Recruitment will begin in the clinic after surgery is scheduled. The patients will be also sign an informed consent form and assent. Patients and parents will be divided into two groups receiving meditation and not receiving meditation. The ideal meditation schedule will be 3-5 meditations per week for 5 minutes beginning 3 weeks before surgery. This will provide a dose-response relationship of meditation to anxiety and postoperative pain for data analysis. For randomization, the patients and their parents will be assigned a number, surveyed at 4-time points, and given a meditation regimen to see how anxiety is affected. The meditation regimen will be linked in a Qualtrics. The control group will only receive the questionnaire without meditation. The survey has eleven questions on a five-point scale ranging from "Not at all" to "A lot"
| Arm | Type | Receives |
|---|---|---|
| 30 study subjects with meditation | Experimental | Behavioral: PeSSKi questionnaire survey, Behavioral: Meditation VideoThe meditation regimen will be linked in a Qualtrics that is delivered to them via email daily. The patient and their parents will open the link, enter their assigned number, and follow the guided meditation embedded in the Qualtrics. This will track how many times and for how long the patients are following the regimen. The first PeSSKi (Perceived Stress Scale for Kids) questionnaire survey will be asked and sent via email after the appointment surgery is scheduled to assess anxiety. The second PeSSKi questionnaire survey will be over email at the halfway point to the surgery to see impact of meditation and anxiety levels at this point. The third questionnaire survey will be done immediately before the day of surgery in person to assess how anxious the patient is. The final questionnaire survey will be done 1 week postoperatively to assess the pain label of the patient is still in after the quantity of analgesic usage logged throughout the week. |
| 30 study subjects without meditation | Placebo comparator | Behavioral: PeSSKi questionnaire surveyThe control group will only receive the questionnaire without meditation. The first PeSSKi questionnaire survey will be asked and sent via email after the appointment where the surgery is scheduled to assess anxiety. The second PeSSKi questionnaire survey will be over email at the halfway point to the surgery to see the anxiety levels are at this point. The third questionnaire survey will be done immediately before the day of the surgery in person to assess how anxious the patient is. The final questionnaire survey will be done 1 week postoperatively to assess how much pain the patient is still in after the quantity of analgesic usage logged throughout the week. The questionnaire has eleven questions on a five-point scale ranging from "Not at all" to "A lot". The questionnaire link is given bellow: https://augusta.qualtrics.com/jfe/form/SV_2b2DZ9x16jY9IzQ (PeSSKi questionnaire) The control group will receive just the PeSSKi questionnaire. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Age 6-18
- Pediatric urology patients at Children's Healthcare of Georgia in Augusta, GA; scheduled for any urological surgery
- Otherwise, healthy patients
- Must record any medical history and medications
- Must record prior attempts of meditation therapy
Key exclusion criteria (3 listed)
- History of any prior surgeries
- History of anxiety or anxiety-related disorders
- Diagnosis of developmental delay
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 |
|---|---|---|
| PeSSKi questionnaire surveyThe control group will only receive the questionnaire without meditation. The PeSSKi questionnaire survey will be receive in 4 time point, First questionnaire will sent via email after the appointment for the surgery is scheduled. The second PeSSKi questionnaire survey will share via email at halfway point to the surgery. The third questionnaire survey will be done immediately before the day of surgery in person to assess how anxious the patient is. The final questionnaire survey will be done 1 week postoperatively to assess how much pain the patient is still in after the quantity of analgesic usage logged throughout the week. | Behavioural | 30 study subjects with meditation, 30 study subjects without meditation |
| Meditation VideoThe experimental group pediatric patients selected for this study and their parents will be receiving meditation and PeSSKi (Perceived Stress Scale for Kids) questionnaire. The ideal meditation schedule will be 3-5 meditations per week for 5 minutes beginning 3 weeks before surgery. This will provide a dose-response relationship of meditation to anxiety and postoperative pain for data analysis. The Patient and their parents will open the link, enter their assigned number, and follow the guided meditation embedded in the Qualtrics. This will track how many times and for how long the patients are following the regimen. The questionnaire has eleven questions on a five-point scale ranging from "Not at all" to "A lot". An example of the meditation video questionnaire is linked here: https://augusta.qualtrics.com/jfe/form/SV_3DeFFKdJVupMJQq (experimental group) https://augusta.qualtrics.com/jfe/form/SV_2b2DZ9x16jY9IzQ (PeSSKi questionnaire) | Behavioural | 30 study subjects with meditation |
Primary outcome
Preoperative Meditation may decrease preoperative anxiety among the patient and their guardians. And to see if longitudinal meditation is associated with decreased postoperative pain by examining frequency of liquid analgesic medicine intake.
Time frame: Active participation in the study will last for about one month, this includes three weeks pre-operatively and one week post-operatively. Total duration of the project is approximately two years.
Number of participants with meditation as assessed to change pain label from baseline in pain score on the scale at 1-week postoperative condition. The final questionnaire survey will be done 1 week postoperatively to assess how much pain the patient is still in after the quantity of analgesic usage logged throughout the week.
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 7 Mar 2025.
- Experimental Group\_ Meditation VideoLink provided by the sponsor.
- PeSSKi (Perceived Stress Scale for Kids) questionnaire for Experimental and control groupLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PeSSKi questionnaire survey and Meditation Video in people with Pediatric Kidney Disease, run by Augusta University at 1 site 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 6 inclusion and 3 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: opening soon, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
Contact Bradley Morganstern, MD (706-721-0982, BMORGANSTERN@augusta.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative Meditation may decrease preoperative anxiety among the patient and their guardians. And to see if longitudinal meditation is associated with decreased postoperative pain by examining frequency of liquid analgesic medicine intake. (time frame: Active participation in the study will last for about one month, this includes three weeks pre-operatively and one week post-operatively. Total duration of the project is approximately two years.). 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 7 Mar 2025.