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Clinical Trial Summary

Cystometry is essential for diagnosis and treatment plans by identifying the causes of lower urinary tract symptoms and objectively evaluating bladder functions in diseases such as neurogenic bladder, voiding dysfunction, and vesicoureteral reflux. Children may experience pain during this invasive procedure of inserting the urethra catheter. Furthermore, infants aged ≥ 6 months may feel pain from an unfamiliar and unnatural environment as they experience stranger anxiety. This experience can have a negative physical and emotional impact on children, and uncooperative behavioral reactions caused by pain can hinder the procedure. In this regard, parental holding is known as effective non-pharmacological procedural pain management in children. Although the International Children's Continence Society has advised performing cystometry while holding the infant as an effective non-pharmacological pain management method, there is insufficient evidence to support this. So, this study aimed to analyze the effect of parental holding on reducing pain in children during cystometry.


Clinical Trial Description

This is an experimental study in a randomized controlled pre-posttest design. During cystometry, participants in the experimental group are placed on the parents' laps and held in the parents' arms. Participants in the control group are laid down on the examination table. The behavioral (FLACC scale) and physiological (oxygen saturation and heart rate) pain responses are measured at three time points (immediately, 3 min, and 10 min after urethral catheter insertion). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05864131
Study type Interventional
Source Yonsei University
Contact
Status Completed
Phase N/A
Start date June 24, 2021
Completion date September 22, 2022

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