Parental Feelings About Their Child Needing a Central Line

Not Applicable

Completed

• Conditions: Critical Illness; Children, Only; Stress
• Interventions: Behavioral: Communication Technique 2

• Registration Number: NCT05842356
• Lead Sponsor: Columbia University

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.

Study Timeline

• Study First Submitted: 2023-04-24
• Study First Submitted QC: 2023-04-24
• Study First Posted: 2023-05-06
• Study Start: 2023-05-19
• Status Verified: 2024-06
• Primary Completion: 2024-06-13
• Study Completion: 2024-06-13
• Last Update Submitted: 2024-06-18
• Last Update Posted: 2024-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Communication Technique 2	Communication Technique 2	A new communication technique will be used in this group.

Primary Outcome Measures

Name	Time	Method
Parental Anxiety	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.
Parental Comfort Providing Consent	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.

Trial Locations

Locations (1)

Columbia University New York-Presbyterian Morgan Stanley Children's Hospital; 🇺🇸 New York, New York, United States