Parental Feelings About Their Child Needing a Central Line

Stress Clinical Trial

Official title:

Parental Feelings About Their Child Needing a Central Line

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05842356
• Other study ID #: AAAU3577
• Status: Completed
• Phase: N/A
• Start date: May 19, 2023
• Est. completion date: June 13, 2024

Study information

• Verified date: June 2024
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 13, 2024
• Est. primary completion date: June 13, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Children, Only
• Critical Illness
• Stress

Intervention

Behavioral:
• Communication Technique 2
A new communication technique.

Locations

Country	Name	City	State
United States	Columbia University New York-Presbyterian Morgan Stanley Children's Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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