Clinical trial NCT01141010: Effect of Psychological Interventions on Maternal Outcomes Undergoing Cesarean
Official title: Effect of Perioperative Psychological Interventions on Maternal Outcomes Undergoing Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perioperative Psychology
Keywords: Linguistic
Stress response
Corticosteroid
Cesarean section
Anxiety
Depression
Maternal psychosis
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: Confidential Enquiry into Maternal and Child Health
First posted: 2010-06-10
Enrollment: 365
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Self anxiety assessment scale (SAS)
timeFrame: One day prior surgery
Secondary outcomes:
measure: Self depression assessment scale (SDS)
timeFrame: One day prior surgery
measure: Visual analog scale of pain (VAS pain)
timeFrame: Five min before surgery (-5 min)
measure: Saliva cortisol level
timeFrame: One day prior surgery
measure: Vital signs
timeFrame: One day prior surgery
measure: SAS scorings
timeFrame: 15 min intraoperation
measure: SAS scorings
timeFrame: 30 min postoperation
measure: SDS scoring
timeFrame: 15 min intraoperation
measure: SDS scoring
timeFrame: 30 min postoperation
measure: VAS pain scoring
timeFrame: Immediately of surgery (0 min)
measure: VAS pain scoring
timeFrame: 5 min after surgery begin (+5 min)
measure: VAS pain scoring
timeFrame: Immediately at the end of surgery (this time changed individually)
measure: VAS pain scoring
timeFrame: 3 h after surgery
measure: Saliva cortisol level
timeFrame: 15 min intraoperation
measure: Saliva cortisol level
timeFrame: 30 min postoperation
measure: Vital signs
timeFrame: 15 min intraoperation
measure: Vital signs
timeFrame: 30 min postoperation
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Maternity and Child Health Care Hospital
state: Jiangsu
Study officials:
affiliation: Nanjing Medical University
name: DongYing Fu, MSc
role: STUDY_DIRECTOR
References: