Effects of Parental Holding on Pain Response in Young Children During Cystometry
May 17, 2023 updated by: Yonsei University
Effects of Parental Holding on Pain Response in Young Children During Cystometry: a Randomized Controlled Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
64
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of
- College of Nursing and Mo-Im Kim Nursing Research Institute, Yonsei University, Seoul, South Korea
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Lying
|
After the urethral catheter is inserted, the participant lies on an examination table lined with paper towels and diapers.
|
|
Experimental: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
Time Frame: 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).
|
Change from immediately, 3 minutes, and 10 minutes after urethral catheter insertion
|
|
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.
Time Frame: 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.
|
Change from immediately, 3 minutes, and 10 minutes after urethral catheter insertion
|
|
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.
Time Frame: 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.
|
Change from immediately, 3 minutes, and 10 minutes after urethral catheter insertion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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. doi: 10.1016/j.jpurol.2021.05.004. Epub 2021 May 11.
- 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.
- 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.
- 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.S267839. eCollection 2021.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 24, 2021
Primary Completion (Actual)
September 22, 2022
Study Completion (Actual)
September 22, 2022
Study Registration Dates
First Submitted
April 28, 2023
First Submitted That Met QC Criteria
May 17, 2023
First Posted (Actual)
May 18, 2023
Study Record Updates
Last Update Posted (Actual)
May 18, 2023
Last Update Submitted That Met QC Criteria
May 17, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4-2021-0583
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
The authors offer the data when requested for a reasonable reason.
IPD Sharing Time Frame
The authors offer the data when requested for a reasonable reason.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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