ClinicalTrials.gov
ClinicalTrials.gov Menu

Organizing the Information Given to Parents of NICU Infants in Order to Reduce Their Anxiety

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00699127
Recruitment Status : Withdrawn (After a discussion, we decided to withdraw the study.)
First Posted : June 17, 2008
Last Update Posted : July 4, 2008
Sponsor:
Information provided by:
Hillel Yaffe Medical Center

Study Description
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Anxiety Behavioral: Lecture Not Applicable

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 Design
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Dose Organizing the Information Given to Parents of NICU Infants Reduce Their Anxiety?
Study Start Date : July 2008
Estimated Primary Completion Date : July 2008
Estimated Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Arms and Interventions
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: 1
The group that will have lecture of information regarding infants in NICU.
 Behavioral: Lecture
Lecture of information regarding prematurity, NICU hospitalization, etc.
No Intervention: 2
The group that will not have lecture of information regarding NICU hospitalization


Outcome Measures
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Difference between questionnaires at the first week and the last week to hospitalization. [ Time Frame: 1 year ]

Eligibility Criteria
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 4 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Parents to premature infants, after releasing the mother

Exclusion Criteria:

  • Term infants
  • Hospitalized mother
Contacts and Locations
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00699127


Locations
Israel
Hillel Yaffe medical center
Hadera, Israel, 38100
Sponsors and Collaborators
Hillel Yaffe Medical Center
Investigators
Study Chair: Erez Nadir, MD Hillel Yaffe medical center, Hadera, Israel
More Information
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Erez Nadir, MD, Hillel Yaffe medical center
ClinicalTrials.gov Identifier: NCT00699127     History of Changes
Other Study ID Numbers: HY-19-2008-CTIL
First Posted: June 17, 2008    Key Record Dates
Last Update Posted: July 4, 2008
Last Verified: July 2008

Keywords provided by Hillel Yaffe Medical Center:
anxiety
parents
NICU
prematurity
Anxiety of parents to NICU infants

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders