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CompletedNCT05842356Updated Jun 21, 2024

Parental Feelings About Their Child Needing a Central Line

An interventional study of Communication Technique 2 in Critical Illness, Children, Only and Stress, sponsored by Columbia University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-21.

Sponsored by Columbia University · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Critical Illness
  • Children, Only
  • Stress

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Keywords

  • Central Venous Line (CVL)
  • Peripherally Inserted Central Catheter (PICC)
03

In context

Critical Illness

1,881 studies on the registry are indexed under Critical Illness; 462 are open to participants now.

This study's enrollment of 28 is below the median of 90 across 979 interventional studies indexed under Critical Illness.

Browse Critical Illness studies →

Lead sponsor

Columbia University is the lead sponsor of 1,103 studies on the registry; 193 are open to participants now.

Of its 172 completed or terminated interventional studies of FDA-regulated products, 142 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
28 participants (actual)

Study arms

  • 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

Interventions

  • BehavioralCommunication Technique 2

    A new communication technique.

06

What researchers measure

Primary outcomes

  1. Parental Anxiety

    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.

    Time frame: 15 minutes

  2. Parental Comfort Providing Consent

    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.

    Time frame: 15 minutes

07

Study locations

1 site
  • Columbia University New York-Presbyterian Morgan Stanley Children's Hospital
    New York, New York 10032, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05842356
Lead sponsor
Columbia University
Responsible party
Jeffrey D. Edwards (Associate Professor of Pediatrics, Columbia University) — Principal investigator
First posted
May 6, 2023
Start date
May 19, 2023
Primary completion
Jun 13, 2024
Completion
Jun 13, 2024
Last update
Jun 21, 2024

Study contacts

Jeffrey Edwards, MD, MA, MS
principal investigator · Columbia University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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