Effect of Psychological Interventions on Maternal Outcomes Undergoing Cesarean

Study Overview
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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.

Official Title
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Effect of Perioperative Psychological Interventions on Maternal Outcomes Undergoing Cesarean Delivery

Conditions
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Perioperative Psychology

Intervention / Treatment
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* Other: Language
* Other: Language


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Plain language<br>Conventional plain language will be given without any psychological intervention | Other: Language<br>* Plain language without psychological intervention<br>|
| Active Comparator: Pre-psycho-language<br>Prior surgery psychological linguistic intervention | Other: Language<br>* Psychological linguistic intervention will be given<br>* Other names: Psycholinguistic;|
| Active Comparator: Intra-psycho-language<br>Intraoperative psychological linguistic intervention | Other: Language<br>* Psychological linguistic intervention will be given<br>* Other names: Psycholinguistic;|
| Active Comparator: Post-psycho-language<br>Postoperative psychological linguistic intervention | Other: Language<br>* Psychological linguistic intervention will be given<br>* Other names: Psycholinguistic;|
| Active Comparator: Combined language<br>Psychological linguistic intervention will be given in a combination of pre-, intra- and post-operatively | Other: Language<br>* Psychological linguistic intervention will be given<br>* Other names: Psycholinguistic;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self anxiety assessment scale (SAS) | Scorings of SAS evaluation by the patient herself | One day prior surgery | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Linguistic, Stress response, Corticosteroid, Cesarean section, Anxiety, Depression, Maternal psychosis