Parental Feelings About Their Child Needing a Central Line

June 18, 2024 updated by: Jeffrey D. Edwards, Columbia University
The goal of this research project is to determine if different communication techniques during the consent process impact parental anxiety and comfort providing consent.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University New York-Presbyterian Morgan Stanley Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Communication Technique 1
A standard communication technique will be used in this group.
Experimental: Communication Technique 2
A new communication technique will be used in this group.
Behavioral: Communication Technique 2
A new communication technique.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
15 minutes
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.
15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Investigators

  • Principal Investigator: Jeffrey Edwards, MD, MA, MS, Columbia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 19, 2023

Primary Completion (Actual)

June 13, 2024

Study Completion (Actual)

June 13, 2024

Study Registration Dates

First Submitted

April 24, 2023

First Submitted That Met QC Criteria

April 24, 2023

First Posted (Actual)

May 6, 2023

Study Record Updates

Last Update Posted (Actual)

June 21, 2024

Last Update Submitted That Met QC Criteria

June 18, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAU3577

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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