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NCT Number: NCT05864131

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

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.

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Key information

Conditions

Vesico-Ureteral Reflux Agnosia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Filum Terminale Lipoma Male Urogenital Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Procedural Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Urinary Bladder Diseases Urogenital Diseases Urologic Diseases

Age range

6 month–18 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Seoul, South Korea

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Lying

Behavioral

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

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.

Primary outcomes

  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).

    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).

  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.

    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.

  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.

    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.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 18, 2023
Registry last updated
May 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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