Effect of Psychological Interventions on Maternal Outcomes Undergoing Cesarean (PIMAC)
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| First Received Date ICMJE | June 3, 2010 | ||||
| Last Updated Date | August 24, 2010 | ||||
| Start Date ICMJE | May 2010 | ||||
| Primary Completion Date | August 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Self anxiety assessment scale (SAS) [ Time Frame: One day prior surgery ] [ Designated as safety issue: Yes ] Scorings of SAS evaluation by the patient herself |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01141010 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effect of Psychological Interventions on Maternal Outcomes Undergoing Cesarean | ||||
| Official Title ICMJE | Effect of Perioperative Psychological Interventions on Maternal Outcomes Undergoing Cesarean Delivery | ||||
| Brief Summary | 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Supportive Care |
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| Condition ICMJE | Perioperative Psychology | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 365 | ||||
| Completion Date | August 2010 | ||||
| Primary Completion Date | August 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 19 Years to 50 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | China | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01141010 | ||||
| Other Study ID Numbers ICMJE | NJFY1021005, 10NJMS067 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | DongYing Fu, Nanjing Maternity and Child Health Care Hospital | ||||
| Study Sponsor ICMJE | Nanjing Medical University | ||||
| Collaborators ICMJE | Confidential Enquiry into Maternal and Child Health | ||||
| Investigators ICMJE |
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| Information Provided By | Nanjing Medical University | ||||
| Verification Date | August 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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