Effect of Perinatal Emotional Management on Maternal Emotion and Delivery Outcomes

NCT ID: NCT01851187

Last Updated: 2013-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2009-12-31

Brief Summary

Pregnancy or childbirth is a kind of persistent and strong source of stress for pregnant women. Prenatal and intrapartum negative emotions not only damage the mental health of pregnant women, but also have a negative impact on the mode of delivery, labor, postpartum complications and neonatal outcomes . Due to considerations for the effect on the fetus, there is concern of the use of drug treatment for depression during pregnancy. Therefore, psychological interventions have an important role. According to the WHO global survey in Asia 2007-08, China had the highest overall rate of caesarean section (46.2%), and also had the highest rate of caesarean section without indication (11.7%). The embarrassing "first in the world" of caesarean section rate was causing widespread concern in China. Recently, the Chinese government has launched a project named "promoting the rate of natural childbirth and protecting the health of mother and child", trying to reduce the cesarean section rate especially that without medical indication. Therefore, examining if emotional management is effective in reducing negative emotions of pregnant women as well as decreasing the rate of cesarean section is an important research question. Our study aims to help the pregnant women control their anxiety, depressive feelings and other negative emotions by "emotional self-management group training" and we examine if this can reduce the incidence of depression and improve delivery outcomes.

Detailed Description

This study tried to explore the effectiveness of prenatal emotional management on pregnant women' delivery outcomes. All participants filled the Questionnaire (PHQ-9) at the baseline assessment. Then they were randomly assigned into the emotional management (EM) group and the usual care (UC) group. The baseline evaluation began at 31 weeks of pregnancy and the mother was followed up to 42 days postpartum. Each subject received the EM package In the EM, and the UC was given only routine prenatal care. PHQ-9 and Edinburgh Postnatal Depression scale（EPDS）were used for assessment.

Conditions

Perinatal Problems; Mental Depression; Complications; Cesarean Section

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

emotional management (EM) group

emotional management (EM) group received antenatal psychological intervention

Group Type: EXPERIMENTAL

antenatal psychological intervention

Intervention Type: BEHAVIORAL

emotion management included:

(1) Establish relationship between the health care workers and the pregnant women, (2) Determine training objectives, (3) Guide to practice relaxation training, including imagination and abdominal breathing. (4) Make cognitive adjustment, (5) Relieve anxiety and tension by scene simulation and stimulus exposure. (6) Learn emotional self-regulation, (7) Improve self-efficacy by group interaction. (8) Teach prenatal knowledge ,(9) Guide interactive trainings between pregnant women and their couples; (10) Visit delivery rooms.

routine prenatal care

Intervention Type: BEHAVIORAL

Prenatal routine inspection included blood pressure, weight, uterine fundal height, abdominal circumference, fetal presentation, fetal position, fetal heart rate and so on.

the usual care (UC) group

the usual care (UC) group was given routine prenatal care only

Group Type: ACTIVE_COMPARATOR

routine prenatal care

Intervention Type: BEHAVIORAL

Prenatal routine inspection included blood pressure, weight, uterine fundal height, abdominal circumference, fetal presentation, fetal position, fetal heart rate and so on.

Interventions

antenatal psychological intervention

emotion management included:

(1) Establish relationship between the health care workers and the pregnant women, (2) Determine training objectives, (3) Guide to practice relaxation training, including imagination and abdominal breathing. (4) Make cognitive adjustment, (5) Relieve anxiety and tension by scene simulation and stimulus exposure. (6) Learn emotional self-regulation, (7) Improve self-efficacy by group interaction. (8) Teach prenatal knowledge ,(9) Guide interactive trainings between pregnant women and their couples; (10) Visit delivery rooms.

Intervention Type: BEHAVIORAL

routine prenatal care

Prenatal routine inspection included blood pressure, weight, uterine fundal height, abdominal circumference, fetal presentation, fetal position, fetal heart rate and so on.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. never have a baby before,

2. with single fetus, head position and normal pelvic measurements,

3. were receiving regular antenatal care,

4. were able to schedule and fulfill questionnaires independently.

Exclusion Criteria

1. situation with pregnancy complications,

2. surgical history of diseases,

3. current or previous history of any kind of mental disorders.

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Zhejiang University

OTHER

Sponsor Role: collaborator

First People's Hospital of Hangzhou

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hejiang Li, MD

Role: PRINCIPAL_INVESTIGATOR

The First People's Hospital of Hangzhou

Locations

The First People's Hospital of Hangzhou

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

Y207858

Identifier Type: -

Identifier Source: org_study_id