- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00699127
Organizing the Information Given to Parents of NICU Infants in Order to Reduce Their Anxiety
July 3, 2008 updated by: Hillel Yaffe Medical Center
Dose Organizing the Information Given to Parents of NICU Infants Reduce Their Anxiety?
Being a parent to a premature infant in NICU is an anxious state.
Parents ask a lot of questions, and look for information all the time.
Organizing the information given to parents could reduce their anxiety.
The parents will be divided into two groups: one group will get organized information, by a lecture at the first week of their infant's life, and the other group will not.
Of course, questions will be answered all the time.
The parents will answer a questionnaire on the first week of the infant's life, and on the last week, just before releasing the infant home.
Study Overview
Detailed Description
Being a parent to a premature infant in NICU is an anxious state.
Parents ask a lot of questions, and look for information all the time.
Organizing the information given to parents could reduce their anxiety.
The parents will be divided into two groups: one group will get organized information, by a lecture at the first week of their infant's life, and the other group will not.
Of course, questions will be answered all the time.
The parents will answer a questionnaire on the first week of the infant's life, and on the last week, just before releasing the infant home.
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Hadera, Israel, 38100
- Hillel Yaffe Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 4 months (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Parents to premature infants, after releasing the mother
Exclusion Criteria:
- Term infants
- Hospitalized mother
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
The group that will have lecture of information regarding infants in NICU.
|
Lecture of information regarding prematurity, NICU hospitalization, etc.
|
No Intervention: 2
The group that will not have lecture of information regarding NICU hospitalization
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Difference between questionnaires at the first week and the last week to hospitalization.
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Erez Nadir, MD, Hillel Yaffe medical center, Hadera, Israel
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2008
Primary Completion (Anticipated)
July 1, 2008
Study Completion (Anticipated)
July 1, 2008
Study Registration Dates
First Submitted
June 14, 2008
First Submitted That Met QC Criteria
June 16, 2008
First Posted (Estimate)
June 17, 2008
Study Record Updates
Last Update Posted (Estimate)
July 4, 2008
Last Update Submitted That Met QC Criteria
July 3, 2008
Last Verified
July 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HY-19-2008-CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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