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Vesico-Ureteral RefluxNCT05864131

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

A study testing Lying and Holding in people with Vesico-Ureteral Reflux and Filum Terminale Lipoma, run by Yonsei University at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 6 to 18 months
What is being tested?
Lying and Holding
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
1 siteSouth Korea
Study dates
24 Jun 2021to 22 Sep 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 18 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

South Korea1 site

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

    Seoul

Other trials in South Korea

About this study

Official title: 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.

Read the 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).

Being tested
Lying, Holding
Keywords
cystometry, children, parental holding, procedural pain, pain response, pain management
Medical subject headings
Vesico-Ureteral Reflux, Pain, Procedural, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LyingBehavioural

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

  • HoldingBehavioural

    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.

Study groups in NCT05864131
Study groupRoleWhat they receive
LyingActive comparatorNot described
Receives: Behavioral: Lying
HoldingExperimentalNot described
Receives: Behavioral: Holding

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Change from immediately, 3 minutes, and 10 minutes after urethral catheter insertion

  2. 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.

    Measured: Change from immediately, 3 minutes, and 10 minutes after urethral catheter insertion

  3. 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.

    Measured: Change from immediately, 3 minutes, and 10 minutes after urethral catheter insertion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2023
  2. Study start24 Jun 2021
  3. Primary completion22 Sep 2022
  4. Study completion22 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05864131
Sponsor's protocol ID
4-2021-0583
Status last verified
May 2023
First submitted
28 Apr 2023
Last updated
18 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The authors offer the data when requested for a reasonable reason.

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.

    PubMed 25998310

  • 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.

    PubMed 30486427

  • 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.

    PubMed 34412976

  • 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.

    PubMed 31464493

  • 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.

    PubMed 25504956

  • 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.

    PubMed 33833566

  • 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.

    PubMed 26630545

Questions about this trial

What is this clinical trial studying?

A study testing Lying and Holding in people with Vesico-Ureteral Reflux and Filum Terminale Lipoma, run by Yonsei University at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05864131, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2023.

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