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

Primary Purpose

Vesico-Ureteral Reflux, Filum Terminale Lipoma

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Lying
Holding
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Vesico-Ureteral Reflux focused on measuring cystometry, children, parental holding, procedural pain, pain response, pain management

Eligibility Criteria

6 Months - 18 Months (Child)All SexesDoes not accept 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).

Sites / Locations

  • College of Nursing and Mo-Im Kim Nursing Research Institute, Yonsei University, Seoul, South Korea

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Lying

Holding

Arm Description

Outcomes

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).
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
April 28, 2023
Last Updated
May 17, 2023
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT05864131
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
June 24, 2021 (Actual)
Primary Completion Date
September 22, 2022 (Actual)
Study Completion Date
September 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vesico-Ureteral Reflux, Filum Terminale Lipoma
Keywords
cystometry, children, parental holding, procedural pain, pain response, pain management

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lying
Arm Type
Active Comparator
Arm Title
Holding
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Lying
Intervention Description
After the urethral catheter is inserted, the participant lies on an examination table lined with paper towels and diapers.
Intervention Type
Behavioral
Intervention Name(s)
Holding
Intervention Description
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.
Primary Outcome Measure Information:
Title
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).
Description
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).
Time Frame
Change from immediately, 3 minutes, and 10 minutes after urethral catheter insertion
Title
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.
Description
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.
Time Frame
Change from immediately, 3 minutes, and 10 minutes after urethral catheter insertion
Title
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.
Description
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.
Time Frame
Change from immediately, 3 minutes, and 10 minutes after urethral catheter insertion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
College of Nursing and Mo-Im Kim Nursing Research Institute, Yonsei University, Seoul, South Korea
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
25998310
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.
Results Reference
result
PubMed Identifier
30486427
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.
Results Reference
result
PubMed Identifier
34412976
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. doi: 10.1016/j.jpurol.2021.05.004. Epub 2021 May 11.
Results Reference
result
PubMed Identifier
31464493
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.
Results Reference
result
PubMed Identifier
25504956
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.
Results Reference
result
PubMed Identifier
33833566
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.S267839. eCollection 2021.
Results Reference
result
PubMed Identifier
26630545
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.
Results Reference
result

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

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