Back to resultsParental Feelings About Their Child Needing a Central Line
Primary Purpose
Critical Illness, Children, Only, Stress
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Communication Technique 2
Sponsored by
About this trial
This is an interventional other trial for Critical Illness focused on measuring Central Venous Line (CVL), Peripherally Inserted Central Catheter (PICC)
Eligibility Criteria
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
Sites / Locations
- Columbia University New York-Presbyterian Morgan Stanley Children's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Communication Technique 1
Communication Technique 2
Arm Description
A standard communication technique will be used in this group.
A new communication technique will be used in this group.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05842356
Brief Title
Parental Feelings About Their Child Needing a Central Line
Official Title
Parental Feelings About Their Child Needing a Central Line
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 19, 2023 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, Children, Only, Stress
Keywords
Central Venous Line (CVL), Peripherally Inserted Central Catheter (PICC)
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Participants (parents) will not know which communication technique group they are in until after their participation.
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Communication Technique 1
Arm Type
No Intervention
Arm Description
A standard communication technique will be used in this group.
Arm Title
Communication Technique 2
Arm Type
Experimental
Arm Description
A new communication technique will be used in this group.
Intervention Type
Behavioral
Intervention Name(s)
Communication Technique 2
Intervention Description
A new communication technique.
Primary Outcome Measure Information:
Title
Parental Anxiety
Description
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.
Time Frame
15 minutes
Title
Parental Comfort Providing Consent
Description
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.
Time Frame
15 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew Spence, MD
Phone
646-825-1336
Email
ms6290@cumc.columbia.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jeffrey Edwards, MD, MA, MS
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Edwards, MD, MA, MS
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University New York-Presbyterian Morgan Stanley Children's Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Spence, MD
Phone
646-825-1336
Email
ms6290@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Jeffrey Edwards, MD, MA, MS
First Name & Middle Initial & Last Name & Degree
Matthew Spence, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Parental Feelings About Their Child Needing a Central Line
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