Back to resultsEpidemiology and Prevention of Anxiety and Depression in Parents of Hospitalized Neonates
Primary Purpose
Depression
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Comprehensive intervention
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring Neonates, Parenting, Anxiety, Depression
Eligibility 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
Sites / Locations
- Nanjing Maternal and Child Care Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Comprehensive intervention
Conventional treatment
Arm Description
Parents of hospitalized neonates received Comprehensive intervention program.
Usual educational program
Outcomes
Primary Outcome Measures
Parental anxiety symptoms
Parents of Hospitalized Neonates were asked to complete the Self-rating Anxiety Scale (SAS) at 3 weeks after enrolment.
Secondary Outcome Measures
Full Information
NCT ID
NCT01310634
First Posted
March 7, 2011
Last Updated
October 24, 2014
Sponsor
Nanjing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT01310634
Brief Title
Epidemiology and Prevention of Anxiety and Depression in Parents of Hospitalized Neonates
Official Title
Epidemiology and Prevention of Anxiety and Depression in Parents of Hospitalized Neonates
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Neonates, Parenting, Anxiety, Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
600 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Comprehensive intervention
Arm Type
Experimental
Arm Description
Parents of hospitalized neonates received Comprehensive intervention program.
Arm Title
Conventional treatment
Arm Type
Other
Arm Description
Usual educational program
Intervention Type
Behavioral
Intervention Name(s)
Comprehensive intervention
Other Intervention Name(s)
Comprehensive intervention program.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Parental anxiety symptoms
Description
Parents of Hospitalized Neonates were asked to complete the Self-rating Anxiety Scale (SAS) at 3 weeks after enrolment.
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shuping Han, PhD
Organizational Affiliation
Nanjing Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Nanjing Maternal and Child Care Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210004
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
23480505
Citation
Kong LP, Cui Y, Qiu YF, Han SP, Yu ZB, Guo XR. Anxiety and depression in parents of sick neonates: a hospital-based study. J Clin Nurs. 2013 Apr;22(7-8):1163-72. doi: 10.1111/jocn.12090.
Results Reference
result
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Epidemiology and Prevention of Anxiety and Depression in Parents of Hospitalized Neonates
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