Clinical trial NCT05864131: Effects of Parental Holding on Pain Response in Young Children During Cystometry
Official title: Effects of Parental Holding on Pain Response in Young Children During Cystometry: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vesico-Ureteral Reflux
Filum Terminale Lipoma
Keywords: cystometry
children
parental holding
procedural pain
pain response
pain management
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2023-05-18
Enrollment: 64
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

Eligibility criteria: 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).

Primary outcomes:
measure: 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).
timeFrame: Change from immediately, 3 minutes, and 10 minutes after urethral catheter insertion
measure: 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.
timeFrame: Change from immediately, 3 minutes, and 10 minutes after urethral catheter insertion
measure: 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.
timeFrame: Change from immediately, 3 minutes, and 10 minutes after urethral catheter insertion
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: College of Nursing and Mo-Im Kim Nursing Research Institute, Yonsei University, Seoul, South Korea
Study officials:
References:
citation: Bauer SB, Nijman RJ, Drzewiecki BA, Sillen U, Hoebeke P; International Children's Continence Society Standardization Subcommittee. International Children's Continence Society standardization report on urodynamic studies of the lower urinary tract in children. Neurourol Urodyn. 2015 Sep;34(7):640-7. doi: 10.1002/nau.22783. Epub 2015 May 21.
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citation: Pillai Riddell RR, Racine NM, Gennis HG, Turcotte K, Uman LS, Horton RE, Ahola Kohut S, Hillgrove Stuart J, Stevens B, Lisi DM. Non-pharmacological management of infant and young child procedural pain. Cochrane Database Syst Rev. 2015 Dec 2;2015(12):CD006275. doi: 10.1002/14651858.CD006275.pub3.