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

Sponsor

Yonsei University (Other)

Overall Status

Completed

CT.gov ID

NCT05864131

Collaborator

(none)

Enrollment

Location

Arms

14.9

Actual Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vesico-Ureteral Reflux Filum Terminale Lipoma	Behavioral: Lying Behavioral: Holding	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

64 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jun 24, 2021

Actual Primary Completion Date :

Sep 22, 2022

Actual Study Completion Date :

Sep 22, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Lying	Behavioral: Lying After the urethral catheter is inserted, the participant lies on an examination table lined with paper towels and diapers.
Experimental: Holding	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.

Arm

Intervention/Treatment

Active Comparator: Lying

Behavioral: Lying

After the urethral catheter is inserted, the participant lies on an examination table lined with paper towels and diapers.

Experimental: Holding

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.

Outcome Measures

Primary Outcome Measures

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 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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months to 18 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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