Effect of Psychological Interventions on Maternal Outcomes Undergoing Cesarean

NCT ID: NCT01141010

Last Updated: 2010-08-25

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

365 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2010-08-31

Brief Summary

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Pregnancy induced psychosis is an essential factor that influencing maternal health postpartum. When gravidas, especially nulliparas, facing labor and delivery, they will undoubtedly encounter burden from their own and surrounding facts. Maternal psychosis takes a large part of women's psychological disorders. No matter which way, either spontaneous or surgical, they would choose, many factors influence their psychological state. Cesarean section poses higher risks for women than vaginal delivery. Therefore, how to seek effective methods to alleviate parturients' psychological stress response possesses pivotal clinical implications. Herein the investigators proposed that different linguistic interventions given pre-, intra- or post-operatively would produce different effect on maternal psychology and internal stress level.

Detailed Description

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Conditions

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Perioperative Psychology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Plain language

Conventional plain language will be given without any psychological intervention

Group Type SHAM_COMPARATOR

Language

Intervention Type OTHER

Plain language without psychological intervention

Pre-psycho-language

Prior surgery psychological linguistic intervention

Group Type ACTIVE_COMPARATOR

Language

Intervention Type OTHER

Psychological linguistic intervention will be given

Intra-psycho-language

Intraoperative psychological linguistic intervention

Group Type ACTIVE_COMPARATOR

Language

Intervention Type OTHER

Psychological linguistic intervention will be given

Post-psycho-language

Postoperative psychological linguistic intervention

Group Type ACTIVE_COMPARATOR

Language

Intervention Type OTHER

Psychological linguistic intervention will be given

Combined language

Psychological linguistic intervention will be given in a combination of pre-, intra- and post-operatively

Group Type ACTIVE_COMPARATOR

Language

Intervention Type OTHER

Psychological linguistic intervention will be given

Interventions

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Language

Plain language without psychological intervention

Intervention Type OTHER

Language

Psychological linguistic intervention will be given

Intervention Type OTHER

Other Intervention Names

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Psycholinguistic

Eligibility Criteria

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Inclusion Criteria

* Chinese gravidas
* Gestational age \>=36 wk
* Nulliparas
* Undergoing selective Cesarean section

Exclusion Criteria

* With recognition problem
* Used or using centrally acting drugs
* With chronic pain
* Refusal participation
* With existed psychiatric disorders
* With history of psychological diseases
* Contraindications for neuraxial anesthesia
Minimum Eligible Age

19 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Confidential Enquiry into Maternal and Child Health

OTHER

Sponsor Role collaborator

Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Nanjing Maternity and Child Health Care Hospital

Principal Investigators

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DongYing Fu, MSc

Role: STUDY_DIRECTOR

Nanjing Medical University

Locations

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Nanjing Maternity and Child Health Care Hospital

Nanjing, Jiangsu, China

Site Status

Countries

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China

Other Identifiers

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10NJMS067

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NJFY1021005

Identifier Type: -

Identifier Source: org_study_id

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