[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596050":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":29,"centralContacts":34,"locations":44,"responsibleParty":57,"collaborators":29,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":63,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":29,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":83,"overallStatus":89,"whyStopped":29,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Istanbul Saglik Bilimleri University","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Aromatherapy","EXPERIMENTAL","Fifteen minutes before the PD session and during the first outflow and inflow phases, aromatherapy will be administered via inhalation. Five drops of 100% pure organic lavender oil will be added to drinking water in a diffuser visible to the child and parent. The diffuser will be plugged in at the bedside, and participants will be warned not to touch the device. Pain and vital signs will be assessed as in the control group.",[13],"Procedure: Aromatherapy",{"label":15,"type":10,"description":16,"interventionNames":17},"Music Therapy","Fifteen minutes before the PD session and during the first outflow and inflow phases, music chosen by the child or parent will be played. Pain and vital signs will be assessed as in the control group.",[18],"Procedure: Music Therapy",{"label":20,"type":10,"description":21,"interventionNames":22},"Control","Peritoneal dialysis treatment will be started with discharge first, and then the amount of dialysate fluid determined by the physician's request will be filled. In the clinical routine, nonpharmacological pain treatment method is not applied during excretion and filling. Nonpharmacological pain treatment method will not be applied to the control group. The \"Wong-Baker Facial Expressions Rating Scale\" and \"Life Signs Evaluation Form\" will be filled in by the researcher at the 0th and 1st minutes of the first discharge and at the 0th and 1st minutes of the first filling.",[23],"Procedure: Control",[25,30,32],{"type":26,"name":9,"description":27,"armGroupLabels":28,"otherNames":29},"PROCEDURE","Fifteen minutes before the PD session and during the first outflow and inflow phases, aromatherapy will be administered via inhalation. Five drops of 100% pure organic lavender oil",[9],null,{"type":26,"name":15,"description":16,"armGroupLabels":31,"otherNames":29},[15],{"type":26,"name":20,"description":21,"armGroupLabels":33,"otherNames":29},[20],[35,40],{"name":36,"role":37,"phone":38,"phoneExt":29,"email":39},"Eda Aktaş, PhD, RN, Associate Professor","CONTACT","+90 530 558 90 36","eda.aktas@sbu.edu.tr",{"name":41,"role":37,"phone":42,"phoneExt":29,"email":43},"Burcu Aykanat Girgin, PhD, RN, Associate Professor","+90 537 920 06 83","burcuaykanat.girgin@sbu.edu.tr",[45],{"facility":46,"status":29,"city":47,"state":48,"zip":49,"country":50,"countryCode":29,"cosmosGeoPoint":51,"geoPoint":56,"contacts":29},"İstanbul Sağlık Bilimleri University","Istanbul","Üsküdar","34899","Turkey (Türkiye)",{"type":52,"coordinates":53},"Point",[54,55],28.94966,41.01384,{"lat":55,"lon":54},{"type":58,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"PRINCIPAL_INVESTIGATOR","Eda Aktaş","PhD, RN, Associate Professor","100596050","aromatherapy-and-music-on-pain-vital-signs-and-parental-satisfaction-in-children-undergoing-peritoneal-dialysis-100596050",false,"NCT07040410","Aromatherapy and Music on Pain, Vital Signs and Parental Satisfaction in Children Undergoing Peritoneal Dialysis","The Effect of Aromatherapy and Music on Pain, Vital Signs and Parental Satisfaction in Children Undergoing Peritoneal Dialysis Treatment: A Randomized Controlled Study","2024-KAEK-11","Inclusion Criteria:\n\n* Children will be included between the ages of 3 and 18 who receive instrumental peritoneal dialysis or continuous outpatient peritoneal dialysis treatment.\n* Children who have a sufficient cognitive level (3-18 years) to determine pain scores,\n* Children who have a healthy hearing and vision system,\n* Children who did not take painkillers, opioids or sedatives 6 hours before the study,\n* Children who have absence of severe pain in another part of the body,\n* Children who have absence of a history of allergies,\n* Children and parents who can speak and understand Turkish.\n\nExclusion Criteria:\n\n* Decline to participate in the study,\n* Peritonitis diagnosis,\n* Pain due to catheter immobilization,\n* Receiving the first session of peritoneal dialysis treatment","ALL","3 Years","18 Years",{"count":73,"type":74},45,"ESTIMATED","INTERVENTIONAL",[77],"NA","This study is an experimental randomized controlled study conducted to compare the effect of two different nonpharmacological treatment methods (aromatherapy and music therapy) on pain, vital signs and parental satisfaction to alleviate or eliminate pain during excretion and filling in children undergoing peritoneal dialysis treatment. The study population consists of pediatric patients aged 3 to 18 years undergoing peritoneal dialysis treatment at Basaksehir Cam and Sakura City Hospital between June 2025- 2026. According to literature, for experimental studies and parametric measurements, at least 30 participants should be included in both experimental and control groups. Therefore, this crossover randomized design will include 45 children per group: control, aromatherapy, and music therapy. Children included in the sample will be assigned to groups based on a crossover randomized design. This method is suitable for studies with a small sample size. Since three different interventions will be applied once per session over three sessions, to avoid bias, the order of interventions will be randomized and labeled as A, B, and C. The researcher will write the names of the interventions on three separate papers, draw them one by one, and assign them accordingly: Method A: Aromatherapy, Method B: Music Therapy, Method C: Control. Then, the six possible sequences (ABC, ACB, BAC, BCA, CAB, CBA) will be written on six papers and drawn randomly to determine the intervention order for each participant.",[80,81,82],"Pain","Vital Signs Monitoring","Parental Satisfaction",[84,85,86,87,88],"peritoneal dialysis treatment","pain management","pain in children","non-pharmacological method","satisfaction","NOT_YET_RECRUITING","2025-06-26",{"date":92,"type":93},"2025-06-27","ACTUAL",{"date":95,"type":74},"2025-06-25",{"date":97,"type":74},"2026-06-25",{"name":5,"class":6},1]