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Epidemiology and Prevention of Anxiety and Depression in Parents of Hospitalized Neonates

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ClinicalTrials.gov Identifier: NCT01310634
Recruitment Status : Completed
First Posted : March 8, 2011
Last Update Posted : October 28, 2014
Sponsor:
Information provided by (Responsible Party):
Zhangbin Yu, Nanjing Medical University

Brief Summary:
The overall goal of this project is to elucidate the epidemiology of anxiety and depression in parents of hospitalized neonates and test a comprehensive intervention program to prevent anxiety and depression in parents in this setting.

Condition or disease Intervention/treatment Phase
Depression Behavioral: Comprehensive intervention Not Applicable

Detailed Description:
Parents of hospitalized neonates experience high stress levels and feelings of helplessness in the neonatal ward and often concern for the health and well being of their fragile infant. Parental stress associated with admission to the neonatal ward of infants has been extensively studied in developed countries for many years, but rarely have epidemiological and intervention studies been reported in Chinese parents of hospitalized neonates. The aim of the present study was to elucidate the epidemiology of anxiety and depression in parents of hospitalized neonates and test a comprehensive intervention program to prevent anxiety and depression in parents in a Chinese hospital.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Epidemiology and Prevention of Anxiety and Depression in Parents of Hospitalized Neonates
Study Start Date : January 2011
Actual Primary Completion Date : September 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Comprehensive intervention
Parents of hospitalized neonates received Comprehensive intervention program.
Behavioral: Comprehensive intervention
Parents of hospitalized neonates received comprehensive intervention program,including parent educational-behavioral intervention program, effective doctor/nurse parent communication,regularly visit the neonatal ward and care the hospitalized neonates under the guidance of a doctor.
Other Name: Comprehensive intervention program.
Conventional treatment
Usual educational program
Behavioral: Comprehensive intervention
Parents of hospitalized neonates received comprehensive intervention program,including parent educational-behavioral intervention program, effective doctor/nurse parent communication,regularly visit the neonatal ward and care the hospitalized neonates under the guidance of a doctor.
Other Name: Comprehensive intervention program.



Primary Outcome Measures :
  1. Parental anxiety symptoms [ Time Frame: 3 weeks ]
    Parents of Hospitalized Neonates were asked to complete the Self-rating Anxiety Scale (SAS) at 3 weeks after enrolment.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Speaks and reads Chinese
  • No severe handicapping conditions or mental diseases
  • Informed consent, no medical dispute
  • Infants born within 28 days to be cared in the neonatal ward for at least 24 hours

Exclusion Criteria:

  • Significant mental health history
  • Newborns died within a week after hospitalization

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): NCT01310634


Locations
China, Jiangsu
Nanjing Maternal and Child Care Hospital
Nanjing, Jiangsu, China, 210004
Sponsors and Collaborators
Nanjing Medical University
Investigators
Study Director: Shuping Han, PhD Nanjing Medical University

Publications of Results:
Responsible Party: Zhangbin Yu, Director, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT01310634     History of Changes
Other Study ID Numbers: NMU-FY2011-236
First Posted: March 8, 2011    Key Record Dates
Last Update Posted: October 28, 2014
Last Verified: October 2014

Keywords provided by Zhangbin Yu, Nanjing Medical University:
Neonates
Parenting
Anxiety
Depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders