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

NCT05864131 | Completed

• 1 other identifier: 4-2021-0583
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Vesico-Ureteral Reflux; Filum Terminale Lipoma

Keywords

cystometry; children; parental holding; procedural pain; pain response; pain management

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Lying

ACTIVE COMPARATOR

Behavioral: Lying

Holding

EXPERIMENTAL

Behavioral: Holding

Interventions

Lying BEHAVIORAL

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

Lying

Holding BEHAVIORAL

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.

Holding

Eligibility Criteria

• Age: 6 Months - 18 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

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

Seoul, South Korea

Location

Related 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 children. Neurourol Urodyn. 2015 Sep;34(7):640-7. doi: 10.1002/nau.22783. Epub 2015 May 21.

  PMID: 25998310 RESULT

• 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.

  PMID: 30486427 RESULT

• 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.

  PMID: 34412976 RESULT

• 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.

  PMID: 31464493 RESULT

• 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.

  PMID: 25504956 RESULT

• 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.

  PMID: 33833566 RESULT

• 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.

  PMID: 26630545 RESULT

MeSH Terms

Conditions

Vesico-Ureteral Reflux; Pain, Procedural; Agnosia

Interventions

Supine Position

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2023
• First Posted: May 18, 2023
• Study Start: June 24, 2021
• Primary Completion: September 22, 2022
• Study Completion: September 22, 2022
• Last Updated: May 18, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The authors offer the data when requested for a reasonable reason.

Locations

KR (1)