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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05842356
Other study ID # AAAU3577
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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