Parental Feelings About Their Child Needing a Central Line

NCT05842356 | Completed

• 1 other identifier: AAAU3577
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness; Children, Only; Stress

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  15 minutes

• 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.

  15 minutes

Study Arms (2)

Communication Technique 1

NO INTERVENTION

A standard communication technique will be used in this group.

Communication Technique 2

EXPERIMENTAL

A new communication technique will be used in this group.

Behavioral: Communication Technique 2

Interventions

Communication Technique 2 BEHAVIORAL

A new communication technique.

Communication Technique 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

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

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jeffrey Edwards, MD, MA, MS

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants (parents) will not know which communication technique group they are in until after their participation.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 6, 2023
• Study Start: May 19, 2023
• Primary Completion: June 13, 2024
• Study Completion: June 13, 2024
• Last Updated: June 21, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)