[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06858267":3,"trial-entities:NCT06858267":103,"trial-summary:NCT06858267":108},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":39,"secondary_outcomes":44,"sex":45,"minimum_age":46,"maximum_age":47,"healthy_volunteers":14,"eligibility_criteria":48,"std_ages":61,"locations":64,"central_contacts":88,"overall_officials":94,"references":95,"see_also_links":96},"NCT06858267","2254633","The Impact of Meditation on Anxiety and Post-Operative Pain in Pediatric Patients Undergoing Urological Surgery","NOT_YET_RECRUITING","2028-12-30","2025-03","2025-03-07","2025-03-01","Augusta University","OTHER",false,"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.\n2. 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.","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'.\n\nMindfulness 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.",[18],"Pediatric Kidney Disease",[6],"INTERVENTIONAL","SUPPORTIVE_CARE",[23],"NA",{"count":25,"type":26},60,"ESTIMATED",[28,35],{"type":29,"name":30,"description":31,"armGroupLabels":32},"BEHAVIORAL","PeSSKi questionnaire survey","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.",[33,34],"30 study subjects with meditation","30 study subjects without meditation",{"type":29,"name":36,"description":37,"armGroupLabels":38},"Meditation Video","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.\n\nThe 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:\n\nhttps:\u002F\u002Faugusta.qualtrics.com\u002Fjfe\u002Fform\u002FSV\\_3DeFFKdJVupMJQq (experimental group) https:\u002F\u002Faugusta.qualtrics.com\u002Fjfe\u002Fform\u002FSV\\_2b2DZ9x16jY9IzQ (PeSSKi questionnaire)",[33],[40],{"measure":41,"description":42,"timeFrame":43},"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.","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.",[],"ALL","6 Years","18 Years",{"inclusion":49,"exclusion":56,"raw_text":60},[50,51,52,53,54,55],"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",[57,58,59],"History of any prior surgeries","History of anxiety or anxiety-related disorders","Diagnosis of developmental delay","Inclusion Criteria:\n\n* Age 6-18\n* Pediatric urology patients at Children's Healthcare of Georgia in Augusta, GA; scheduled for any urological surgery\n* Otherwise, healthy patients\n* Must record any medical history and medications\n* Must record prior attempts of meditation therapy\n* Children must provide assent\n\nExclusion Criteria:\n\n* History of any prior surgeries\n* History of anxiety or anxiety-related disorders\n* Diagnosis of developmental delay",[62,63],"CHILD","ADULT",[65],{"facility":12,"city":66,"state":67,"zip":68,"country":69,"contacts":70,"geoPoint":85},"Augusta","Georgia","30912","United States",[71,76,80,82],{"name":72,"role":73,"phone":74,"email":75},"Bradley Morganstern, MD","CONTACT","706-721-0982","BMORGANSTERN@augusta.edu",{"name":77,"role":73,"phone":78,"email":79},"Patty Ray, Phd Physioogy","7067219680","PARAY@augusta.edu",{"name":72,"role":81},"PRINCIPAL_INVESTIGATOR",{"name":83,"role":84},"Ali Abolhassani, MD","SUB_INVESTIGATOR",{"lat":86,"lon":87},33.47097,-81.97484,[89,90],{"name":72,"role":73,"phone":74,"email":75},{"name":91,"role":73,"phone":92,"email":93},"Masuma Anwar, Pharmacy","706-721-9680","maanwar@augusta.edu",[],[],[97,100],{"label":98,"url":99},"Experimental Group\\_ Meditation Video","https:\u002F\u002Faugusta.qualtrics.com\u002Fjfe\u002Fform\u002FSV_3DeFFKdJVupMJQq",{"label":101,"url":102},"PeSSKi (Perceived Stress Scale for Kids) questionnaire for Experimental and control group","https:\u002F\u002Faugusta.qualtrics.com\u002Fjfe\u002Fform\u002FSV_2b2DZ9x16jY9IzQ",{"nct_id":4,"conditions":104,"biomarkers":107},[105,106],"Childhood Kidney Disorder","Urinary System Disorder",[],{"nct_id":4,"found":109,"summary":110,"prompt_version":120},true,{"design":111,"status":112,"heading":113,"summary":114,"follow_up":115,"word_count":116,"commitments":117,"compensation":118,"drugs_mentioned":119},"This is an interventional study planning to enroll 60 participants. Participants will be divided into a group that receives meditation and questionnaires, and a control group that only receives questionnaires.","completed","Meditation for Anxiety and Pain in Pediatric Urology Surgery","This study is looking at whether meditation can help reduce anxiety and pain in children aged 6 to 18 who are having urological surgery. Some children and their parents will watch meditation videos regularly for three weeks before surgery and continue for one week after. They will also fill out a questionnaire called PeSSKi (Perceived Stress Scale for Kids). Another group will only complete the questionnaire. The researchers want to see if meditation helps lower anxiety before surgery and reduces the need for pain medicine afterward. The study is currently recruiting 60 participants at Children's Healthcare of Georgia in Augusta, GA, and its status is unclear.","Active participation in the study will last for about one month, including three weeks pre-operatively and one week post-operatively.",106,"If you join, you or your child will participate for about one month, including three weeks before surgery and one week after. This involves watching meditation videos (if in the experimental group) and completing questionnaires.","Not stated in the trial record.",[36],"v2"]