Critical IllnessNCT05842356
Parental Feelings About Their Child Needing a Central Line
A study testing Communication Technique 2 in people with Critical Illness and Children, Only, run by Columbia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Critical Illness, Children, Only, Stress
- What is being tested?
- Communication Technique 2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 19 May 2023to 13 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University New York-Presbyterian Morgan Stanley Children's Hospital
New York, New York, 10032
About this study
The goal of this research project is to determine if different communication techniques during the consent process impact parental anxiety and comfort providing consent.
Read the 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.
- Conditions
- Critical Illness, Children, Only, Stress
- Being tested
- Communication Technique 2
- Keywords
- Central Venous Line (CVL), Peripherally Inserted Central Catheter (PICC)
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Communication Technique 2Behavioural
A new communication technique.
| Study group | Role | What they receive |
|---|---|---|
| Communication Technique 1 | No intervention | A standard communication technique will be used in this group. |
| Communication Technique 2 | Experimental | A new communication technique will be used in this group. Receives: Behavioral: Communication Technique 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start19 May 2023
- Primary completion13 Jun 2024
- Study completion13 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey D. Edwards, Columbia University
- Investigators
- Jeffrey Edwards, MD, MA, MS, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05842356
- Sponsor's protocol ID
- AAAU3577
- Status last verified
- Jun 2024
- First submitted
- 24 Apr 2023
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parental Feelings About Their Child Needing a Central Line
- ClinicalTrials.gov ID
- NCT05842356
- Acronym / sponsor ID
- AAAU3577
- Conditions
- Critical Illness, Children, Only, Stress
- Keywords
- Central Venous Line (CVL), Peripherally Inserted Central Catheter (PICC)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 19 May 2023 (actual)
- Primary completion
- 13 Jun 2024 (actual)
- Study completion
- 13 Jun 2024 (actual)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Communication Technique 1 | No intervention | –A standard communication technique will be used in this group. |
| Communication Technique 2 | Experimental | Behavioral: Communication Technique 2A new communication technique will be used in this group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Communication Technique 2A new communication technique. | Behavioural | Communication Technique 2 |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Edwards, MD, MA, MS principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Communication Technique 2 in people with Critical Illness and Children, Only, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parental Anxiety (time frame: 15 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024.