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

Yonsei University

Status: Completed

Conditions: Filum Terminale Lipoma; Vesico-Ureteral Reflux

Treatments: Behavioral: Lying; Behavioral: Holding

Study type: Interventional

Funder types: Other

Identifiers

NCT05864131

4-2021-0583

Details and patient eligibility

About

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.

Full 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).

Enrollment: 64 patients

Sex: All

Ages: 6 to 18 months old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

Lying

Active Comparator group

Treatment:

Behavioral: Lying

Holding

Experimental group

Treatment:

Behavioral: Holding