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Completed

NCT Number: NCT05842356

Parental Feelings About Their Child Needing a Central Line

The goal of this research project is to determine if different communication techniques during the consent process impact parental anxiety and comfort providing consent.

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Key information

Conditions

Critical Illness Children, Only Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Stress

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University New York-Presbyterian Morgan Stanley Children's Hospital

New York, 10032, United States

About this study

The parents of children in the pediatric intensive care units (PICUs) at Columbia University may be asked if they are interested in participating in this study if their child needs a central venous line (CVL) or peripherally inserted central catheter (PICC) placed.

If the parents are interested in participating, they will be randomly assigned to a communication technique group while they are discussing the procedure and giving consent with a medical team member. After they provide consent, they will be asked to complete surveys about their thoughts and feelings. The study should take about 15 minutes.

After data is collected, the researchers will compare survey answers between the two communication styles used with parents.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Parent or guardian of a child admitted to the pediatric intensive care units (PICUs) at Columbia University
  • The child needs a central venous line (CVL) or peripherally inserted central catheter (PICC) placed in the PICU
  • The parent or guardian speaks English or Spanish

Exclusion criteria

  • Parents or guardians who speak languages other than English or Spanish
  • Parents or guardians of children who need a CVL or PICC placed during an emergency without consent
  • Parents or guardians who are unable to be physically present and provide consent over the phone

Treatment and study plan

Communication Technique 2

Behavioral

A new communication technique.

Primary outcomes

  1. Parental Anxiety

    Time frame: 15 minutes

    The parental anxiety survey is a tool used to measure levels of parental anxiety at the time of consent. Scores range from 7 to 28 with lower scores representing lower levels of anxiety.

  2. Parental Comfort Providing Consent

    Time frame: 15 minutes

    The parental comfort providing consent survey score is a tool used to measure parental comfort in providing consent. Scores range from 0 to 24 with lower scores representing higher levels of comfort.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 6, 2023
Registry last updated
Jun 21, 2024

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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