NCT05864131

Effects of Parental Holding on Pain Response in Young Children During Cystometry

Effects of Parental Holding on Pain Response in Young Children During Cystometry: a Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 6 Months – 18 Months
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Vesico-Ureteral Reflux
• Filum Terminale Lipoma

Interventions

Type	Name	Description
BEHAVIORAL	Lying	After the urethral catheter is inserted, the participant lies on an examination table lined with paper towels and diapers.
BEHAVIORAL	Holding	Holding is performed as a non-pharmacological intervention to relieve pain in children during cystometry. After the urethral catheter is inserted, the participant's parent sits in the chair, placing a paper towel and diaper on their lap. The researcher lifts the participant by the shoulder and puts them on their parent's lap, and the parent holds the participant in their arms.

Timeline

• Start date: 2021-06-24
• Primary completion: 2022-09-22
• Completion: 2022-09-22
• First posted: 2023-05-18
• Last updated: 2023-05-18

Locations

1 site across 1 country: South Korea