Skip to content

Parental Feelings About Their Child Needing a Central Line

Parental Feelings About Their Child Needing a Central Line

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05842356
Enrollment
28
Registered
2023-05-06
Start date
2023-05-19
Completion date
2024-06-13
Last updated
2024-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children, Only, Critical Illness, Stress

Keywords

Central Venous Line (CVL), Peripherally Inserted Central Catheter (PICC)

Brief 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.

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.

Interventions

BEHAVIORALCommunication Technique 2

A new communication technique.

Sponsors

Columbia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Masking description

Participants (parents) will not know which communication technique group they are in until after their participation.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Parental Anxiety15 minutesThe 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.
Parental Comfort Providing Consent15 minutesThe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026