Parental Feelings About Their Child Needing a Central Line

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.

Official Title
-----------------
Parental Feelings About Their Child Needing a Central Line

Conditions
-----------------
Critical Illness, Children, Only, Stress

Intervention / Treatment
-----------------
* Behavioral: Communication Technique 2


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Communication Technique 1<br>A standard communication technique will be used in this group. | |
| Experimental: Communication Technique 2<br>A new communication technique will be used in this group. | Behavioral: Communication Technique 2<br>* A new communication technique.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Central Venous Line (CVL), Peripherally Inserted Central Catheter (PICC)