Parental Feelings About Their Child Needing a Central Line

Sponsor

Columbia University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05842356

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Critical Illness Children, Only Stress	Behavioral: Communication Technique 2	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Masking Description:

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

Primary Purpose:

Other

Official Title:

Parental Feelings About Their Child Needing a Central Line

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Communication Technique 1 A standard communication technique will be used in this group.
Experimental: Communication Technique 2 A new communication technique will be used in this group.	Behavioral: Communication Technique 2 A new communication technique.

Arm

Intervention/Treatment

No Intervention: Communication Technique 1

A standard communication technique will be used in this group.

Experimental: Communication Technique 2

A new communication technique will be used in this group.

Behavioral: Communication Technique 2

A new communication technique.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Columbia University New York-Presbyterian Morgan Stanley Children's Hospital	New York	New York	United States	10032

Sponsors and Collaborators

Columbia University

Investigators

Principal Investigator: Jeffrey Edwards, MD, MA, MS, Columbia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jeffrey D. Edwards, Associate Professor of Pediatrics, Columbia University

ClinicalTrials.gov Identifier:

NCT05842356

Other Study ID Numbers:

AAAU3577

First Posted:

May 6, 2023

Last Update Posted:

May 6, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Jeffrey D. Edwards, Associate Professor of Pediatrics, Columbia University

Central Venous Line (CVL)

Peripherally Inserted Central Catheter (PICC)

Additional relevant MeSH terms:

Critical Illness

Study Results

No Results Posted as of May 6, 2023