Clinical Trial

Aromatherapy and Music on Pain, Vital Signs and Parental Satisfaction in Children Undergoing Peritoneal Dialysis

Study acronym: 2024-KAEK-11
Not Yet Recruiting
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Record status
This record was last updated June 27, 2025 (before its estimated June 25, 2026 completion). Its status may not reflect the trial's current state.
Summary
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.
Trial Details
NCT Number NCT07040410
Lead Sponsor Istanbul Saglik Bilimleri University
Conditions Pain, Vital Signs Monitoring, Parental Satisfaction
Enrollment 45 participants
Start Date 2025-06-25
Primary Completion 2026-06-25 (estimated)
Study Completion 2026-06-25 (estimated)
Updated on ClinicalTrials.gov 2025-06-27