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Clinical Trials/NCT01141010
NCT01141010
Completed
Not Applicable

Effect of Perioperative Psychological Interventions on Maternal Outcomes Undergoing Cesarean Delivery

Nanjing Medical University1 site in 1 country365 target enrollmentMay 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Perioperative Psychology
Sponsor
Nanjing Medical University
Enrollment
365
Locations
1
Primary Endpoint
Self anxiety assessment scale (SAS)
Status
Completed
Last Updated
15 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2010
End Date
August 2010
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Nanjing Medical University

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

Outcomes

Primary Outcomes

Self anxiety assessment scale (SAS)

Time Frame: One day prior surgery

Scorings of SAS evaluation by the patient herself

Secondary Outcomes

  • Self depression assessment scale (SDS)(One day prior surgery)
  • Visual analog scale of pain (VAS pain)(Five min before surgery (-5 min))
  • Saliva cortisol level(30 min postoperation)
  • Vital signs(30 min postoperation)
  • SAS scorings(30 min postoperation)
  • SDS scoring(30 min postoperation)
  • VAS pain scoring(3 h after surgery)

Study Sites (1)

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