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

Vesico-Ureteral Reflux Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05864131
• Other study ID #: 4-2021-0583
• Status: Completed
• Phase: N/A
• Start date: June 24, 2021
• Est. completion date: September 22, 2022

Study information

• Verified date: May 2023
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: September 22, 2022
• Est. primary completion date: September 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 18 Months

Eligibility

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).

Related Conditions & MeSH terms

• Vesico-Ureteral Reflux

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	College of Nursing and Mo-Im Kim Nursing Research Institute, Yonsei University, Seoul, South Korea	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (7)

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 child — View Citation

Crellin D, Harrison D, Santamaria N, Babl FE. Comparison of the Psychometric Properties of the FLACC Scale, the MBPS and the Observer Applied Visual Analogue Scale Used to Assess Procedural Pain. J Pain Res. 2021 Mar 31;14:881-892. doi: 10.2147/JPR.S26783 — View Citation

Hatfield LA, Ely EA. Measurement of acute pain in infants: a review of behavioral and physiological variables. Biol Res Nurs. 2015 Jan;17(1):100-11. doi: 10.1177/1099800414531448. Epub 2014 May 1. — View Citation

LoBue V, Adolph KE. Fear in infancy: Lessons from snakes, spiders, heights, and strangers. Dev Psychol. 2019 Sep;55(9):1889-1907. doi: 10.1037/dev0000675. — View Citation

Pancekauskaite G, Jankauskaite L. Paediatric Pain Medicine: Pain Differences, Recognition and Coping Acute Procedural Pain in Paediatric Emergency Room. Medicina (Kaunas). 2018 Nov 27;54(6):94. doi: 10.3390/medicina54060094. — View 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):CD006 — View Citation

Yerkes EB, Cheng EY, Wiener JS, Austin JC, Tu DD, Joseph DB, Routh JC, Tanaka ST. Translating pediatric urodynamics from clinic into collaborative research: Lessons and recommendations from the UMPIRE study group. J Pediatr Urol. 2021 Oct;17(5):716-725. d — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	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).	Change from immediately, 3 minutes, and 10 minutes after urethral catheter insertion
Primary	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.	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.	Change from immediately, 3 minutes, and 10 minutes after urethral catheter insertion
Primary	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.	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.	Change from immediately, 3 minutes, and 10 minutes after urethral catheter insertion