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

Primary Purpose

Anxiety

Status
Withdrawn
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Lecture
Sponsored by
Hillel Yaffe Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety focused on measuring anxiety, parents, NICU, prematurity, Anxiety of parents to NICU infants

Eligibility Criteria

undefined - 4 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Parents to premature infants, after releasing the mother

Exclusion Criteria:

  • Term infants
  • Hospitalized mother

Sites / Locations

  • Hillel Yaffe medical center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

The group that will have lecture of information regarding infants in NICU.

The group that will not have lecture of information regarding NICU hospitalization

Outcomes

Primary Outcome Measures

Difference between questionnaires at the first week and the last week to hospitalization.

Secondary Outcome Measures

Full Information

First Posted
June 14, 2008
Last Updated
July 3, 2008
Sponsor
Hillel Yaffe Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00699127
Brief Title
Organizing the Information Given to Parents of NICU Infants in Order to Reduce Their Anxiety
Official Title
Dose Organizing the Information Given to Parents of NICU Infants Reduce Their Anxiety?
Study Type
Interventional

2. Study Status

Record Verification Date
July 2008
Overall Recruitment Status
Withdrawn
Why Stopped
After a discussion, we decided to withdraw the study.
Study Start Date
July 2008 (undefined)
Primary Completion Date
July 2008 (Anticipated)
Study Completion Date
July 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Hillel Yaffe Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
Keywords
anxiety, parents, NICU, prematurity, Anxiety of parents to NICU infants

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
The group that will have lecture of information regarding infants in NICU.
Arm Title
2
Arm Type
No Intervention
Arm Description
The group that will not have lecture of information regarding NICU hospitalization
Intervention Type
Behavioral
Intervention Name(s)
Lecture
Intervention Description
Lecture of information regarding prematurity, NICU hospitalization, etc.
Primary Outcome Measure Information:
Title
Difference between questionnaires at the first week and the last week to hospitalization.
Time Frame
1 year

10. Eligibility

Sex
All
Maximum Age & Unit of Time
4 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Parents to premature infants, after releasing the mother Exclusion Criteria: Term infants Hospitalized mother
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erez Nadir, MD
Organizational Affiliation
Hillel Yaffe medical center, Hadera, Israel
Official's Role
Study Chair
Facility Information:
Facility Name
Hillel Yaffe medical center
City
Hadera
ZIP/Postal Code
38100
Country
Israel

12. IPD Sharing Statement

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

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