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

NCT ID: NCT01310634

Last Updated: 2014-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-12-31

Brief Summary

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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

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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.

Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Comprehensive intervention

Parents of hospitalized neonates received Comprehensive intervention program.

Group Type EXPERIMENTAL

Comprehensive intervention

Intervention Type BEHAVIORAL

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.

Conventional treatment

Usual educational program

Group Type OTHER

Comprehensive intervention

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Comprehensive intervention program.

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Zhangbin Yu

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shuping Han, PhD

Role: STUDY_DIRECTOR

Nanjing Medical University

Locations

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Nanjing Maternal and Child Care Hospital

Nanjing, Jiangsu, China

Site Status

Countries

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China

References

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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.

Reference Type RESULT
PMID: 23480505 (View on PubMed)

Other Identifiers

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NMU-FY2011-236

Identifier Type: -

Identifier Source: org_study_id

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