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

Not Applicable

Completed

• Conditions: Filum Terminale Lipoma; Vesico-Ureteral Reflux
• Interventions: Behavioral: Holding; Behavioral: Lying

• Registration Number: NCT05864131
• Lead Sponsor: Yonsei University

Brief 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).

Study Timeline

• Study Start: 2021-06-24
• Primary Completion: 2022-09-22
• Study Completion: 2022-09-22
• Study First Submitted: 2023-04-28
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-17
• Last Update Submitted: 2023-05-17
• Study First Posted: 2023-05-18
• Last Update Posted: 2023-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

1. The children aged 6-18 months.
2. The children who undergo cystometry for the first time.
3. The children who undergo cystometry with their parents.

Exclusion Criteria

1. The child who is premature or has a low birth weight
2. The primary caregiver is not the participant's parent
3. The child who has unstable vital signs
4. The child is expected to have neurological or sensory impairments (e.g., spinal cord inflammation, spina bifida).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Holding	Holding	-
Lying	Lying	-

Primary Outcome Measures

Name	Time	Method
Behavioral pain response change measured using the FLACC(Faces, Legs, Activity, Crying, and Consolability) scale between each time point (immediately, 3 min, and 10 min after urethral catheter insertion).	Change from immediately, 3 minutes, and 10 minutes after urethral catheter insertion	Behavioral pain response refers to facial expression changes, body movements, postures, and crying on pain stimuli. This is measured using the FLACC scale developed to evaluate acute pain in children. According to the FLACC scale, pain is rated using a total of five subcategories (Faces, Legs, Activity, Crying, and Consolability) on a scale of 0-2, and the scores are summed (range 0 to 10).
Physiological pain responses change measured using heart rate (beats/min) . Change between each time point (immediately, 3 min, and 10 min after urethral catheter insertion), automatically measured by a Pulse oximeter.	Change from immediately, 3 minutes, and 10 minutes after urethral catheter insertion	The heart rate (beats/minute) is automatically measured by a Nellcor OxiMax N-560 Pulse oximeter (Nellcor Puritan Bennett LLC, USA), and a Nellcor SpO2 sensor (Nellcor Puritan Bennett LLC, USA) is attached to the participants' toes.
Physiological pain responses change measured using oxygen saturation (%/min). Change between each time point (immediately, 3 min, and 10 min after urethral catheter insertion), automatically measured by a Pulse oximeter.	Change from immediately, 3 minutes, and 10 minutes after urethral catheter insertion	The oxygen saturation (%/minute) is automatically measured by a Nellcor OxiMax N-560 Pulse oximeter (Nellcor Puritan Bennett LLC, USA), and a Nellcor SpO2 sensor (Nellcor Puritan Bennett LLC, USA) is attached to the participants' toes.

Trial Locations

Locations (1)

College of Nursing and Mo-Im Kim Nursing Research Institute, Yonsei University, Seoul, South Korea; 🇰🇷 Seoul, Korea, Republic of