Parental Feelings About Their Child Needing a Central Line
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Columbia University
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Parental Anxiety
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Participant)
Masking Description
Participants (parents) will not know which communication technique group they are in until after their participation.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
Outcomes
Primary Outcomes
Parental Anxiety
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Jeffrey D. Edwards
Associate Professor of Pediatrics
Columbia University