Parental Feelings About Their Child Needing a Central Line

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-19

Study Completion Date

2024-06-13

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this research project is to determine if different communication techniques during the consent process impact parental anxiety and comfort providing consent.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Family Nurture Intervention, A Group Model in Connecticut

NCT02970565

Behavior Problem Development Delay Emotional Disturbance +1 more

COMPLETED NA

Family-Centered Behavioral Preparation for Surgery

NCT00261261

Anxiety

COMPLETED NA

Empowering Anxious Parents to Manage Child Avoidance Behaviors

NCT04453865

Anxiety Disorders

COMPLETED NA

Evaluating the Impact of Reining in Anxiety

NCT04825756

Anxiety Anxiety Disorder

COMPLETED NA

Pilot of an Online Sexual Health Program

NCT06564025

Program, Communication

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Critical Illness Children, Only Stress

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

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

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Communication Technique 1

A standard communication technique will be used in this group.

Group Type NO_INTERVENTION

No interventions assigned to this group

Communication Technique 2

A new communication technique will be used in this group.

Group Type EXPERIMENTAL

Communication Technique 2

Intervention Type BEHAVIORAL

A new communication technique.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Communication Technique 2

A new communication technique.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes