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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01310634
• Other study ID #: NMU-FY2011-236
• Status: Completed
• Phase: N/A
• First received: March 7, 2011
• Last updated: October 24, 2014
• Start date: January 2011
• Est. completion date: December 2011

Study information

• Verified date: October 2014
• Source: Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: December 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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.

Locations

Country	Name	City	State
China	Nanjing Maternal and Child Care Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Medical University

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parental anxiety symptoms	Parents of Hospitalized Neonates were asked to complete the Self-rating Anxiety Scale (SAS) at 3 weeks after enrolment.	3 weeks	No