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| ID | Type | Description | Link |
|---|---|---|---|
| 10NJMS067 | Other Grant/Funding Number | Nanjing Municipal Bureau of Health |
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| Name | Class |
|---|---|
| Confidential Enquiry into Maternal and Child Health | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plain language | Sham Comparator | Conventional plain language will be given without any psychological intervention |
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| Pre-psycho-language | Active Comparator | Prior surgery psychological linguistic intervention |
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| Intra-psycho-language | Active Comparator | Intraoperative psychological linguistic intervention |
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| Post-psycho-language | Active Comparator | Postoperative psychological linguistic intervention |
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| Combined language | Active Comparator | Psychological linguistic intervention will be given in a combination of pre-, intra- and post-operatively |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Language | Other | Plain language without psychological intervention |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Self anxiety assessment scale (SAS) | Scorings of SAS evaluation by the patient herself | One day prior surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Self depression assessment scale (SDS) | Scorings of SDS by the patient herself | One day prior surgery |
| Visual analog scale of pain (VAS pain) | Patient self assessed pain scorings with a 100 mm (0-100) scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| DongYing Fu, MSc | Nanjing Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing Maternity and Child Health Care Hospital | Nanjing | Jiangsu | 210004 | China |
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| ID | Term |
|---|---|
| D015775 | Fractures, Stress |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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| ID | Term |
|---|---|
| D011578 | Psycholinguistics |
| ID | Term |
|---|---|
| D001525 | Behavioral Sciences |
| D004191 | Behavioral Disciplines and Activities |
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| Language |
| Other |
Psychological linguistic intervention will be given |
|
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| Five min before surgery (-5 min) |
| Saliva cortisol level | Saliva cortisol levels will be measured with EIA | One day prior surgery |
| Vital signs | Blood pressure, heart rate, respiratory rate, oral temperature | One day prior surgery |
| SAS scorings | Scorings of SAS by patient herself | 15 min intraoperation |
| SAS scorings | Scorings of SAS by the patient herself | 30 min postoperation |
| SDS scoring | Scorings of SDS by patient herself | 15 min intraoperation |
| SDS scoring | Scorings of SDS by patient herself | 30 min postoperation |
| VAS pain scoring | VAS scorings of pain by a 100 mm scale | Immediately of surgery (0 min) |
| VAS pain scoring | Scorings of VAS pain by a 100 mm scale | 5 min after surgery begin (+5 min) |
| VAS pain scoring | Scorings of VAS pain by a 100 mm scale | Immediately at the end of surgery (this time changed individually) |
| VAS pain scoring | Scorings of VAS pain by a 100 mm scale | 3 h after surgery |
| Saliva cortisol level | Saliva cortisol level will be measured with EIA | 15 min intraoperation |
| Saliva cortisol level | Saliva cortisol level will be measured with EIA | 30 min postoperation |
| Vital signs | Blood pressure, heart rate, respiratory rate, oral temperature | 15 min intraoperation |
| Vital signs | Blood pressure, heart rate, respiratory rate, oral temperature | 30 min postoperation |
| D001519 |
| Behavior |