Effect of Psychological Interventions on Maternal Outcomes Undergoing Cesarean (PIMAC)

This study has been completed.
Sponsor:
Collaborator:
Confidential Enquiry into Maternal and Child Health
Information provided by:
Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT01141010
First received: June 3, 2010
Last updated: August 24, 2010
Last verified: August 2010

June 3, 2010
August 24, 2010
May 2010
August 2010   (final data collection date for primary outcome measure)
Self anxiety assessment scale (SAS) [ Time Frame: One day prior surgery ] [ Designated as safety issue: Yes ]
Scorings of SAS evaluation by the patient herself
Same as current
Complete list of historical versions of study NCT01141010 on ClinicalTrials.gov Archive Site
  • Self depression assessment scale (SDS) [ Time Frame: One day prior surgery ] [ Designated as safety issue: Yes ]
    Scorings of SDS by the patient herself
  • Visual analog scale of pain (VAS pain) [ Time Frame: Five min before surgery (-5 min) ] [ Designated as safety issue: Yes ]
    Patient self assessed pain scorings with a 100 mm (0-100) scale
  • Saliva cortisol level [ Time Frame: One day prior surgery ] [ Designated as safety issue: No ]
    Saliva cortisol levels will be measured with EIA
  • Vital signs [ Time Frame: One day prior surgery ] [ Designated as safety issue: Yes ]
    Blood pressure, heart rate, respiratory rate, oral temperature
  • SAS scorings [ Time Frame: 15 min intraoperation ] [ Designated as safety issue: Yes ]
    Scorings of SAS by patient herself
  • SAS scorings [ Time Frame: 30 min postoperation ] [ Designated as safety issue: Yes ]
    Scorings of SAS by the patient herself
  • SDS scoring [ Time Frame: 15 min intraoperation ] [ Designated as safety issue: Yes ]
    Scorings of SDS by patient herself
  • SDS scoring [ Time Frame: 30 min postoperation ] [ Designated as safety issue: Yes ]
    Scorings of SDS by patient herself
  • VAS pain scoring [ Time Frame: Immediately of surgery (0 min) ] [ Designated as safety issue: Yes ]
    VAS scorings of pain by a 100 mm scale
  • VAS pain scoring [ Time Frame: 5 min after surgery begin (+5 min) ] [ Designated as safety issue: Yes ]
    Scorings of VAS pain by a 100 mm scale
  • VAS pain scoring [ Time Frame: Immediately at the end of surgery (this time changed individually) ] [ Designated as safety issue: Yes ]
    Scorings of VAS pain by a 100 mm scale
  • VAS pain scoring [ Time Frame: 3 h after surgery ] [ Designated as safety issue: Yes ]
    Scorings of VAS pain by a 100 mm scale
  • Saliva cortisol level [ Time Frame: 15 min intraoperation ] [ Designated as safety issue: No ]
    Saliva cortisol level will be measured with EIA
  • Saliva cortisol level [ Time Frame: 30 min postoperation ] [ Designated as safety issue: No ]
    Saliva cortisol level will be measured with EIA
  • Vital signs [ Time Frame: 15 min intraoperation ] [ Designated as safety issue: Yes ]
    Blood pressure, heart rate, respiratory rate, oral temperature
  • Vital signs [ Time Frame: 30 min postoperation ] [ Designated as safety issue: No ]
    Blood pressure, heart rate, respiratory rate, oral temperature
  • Self depression assessment scale (SDS) [ Time Frame: One day prior surgery, 15 min intraoperation, 30 min postoperation ] [ Designated as safety issue: Yes ]
    Scorings of SDS by the patient herself
  • Visual analog scale of pain (VAS pain) [ Time Frame: Five min before surgery (-5 min); immediately of surgery (0 min); 5 min after surgery begin (+5 min); immediately at the end of surgery (this time changed individually); 3 h, 6 h,12 h and 24h after surgery ] [ Designated as safety issue: Yes ]
    Patient self assessed pain scorings with a 100 mm (0-100) scale
  • Saliva cortisol level [ Time Frame: One day prior surgery, 15 min intraoperation, 30 min postoperation ] [ Designated as safety issue: No ]
    Saliva corticol levels will be measured with ELSA
  • Vital signs [ Time Frame: One day prior surgery, 15 min intraoperation, 30 min postoperation ] [ Designated as safety issue: Yes ]
    Blood pressure, heart rate, respiratory rate, oral temperature
  • SAS scorings [ Time Frame: 15 min intraoperation ] [ Designated as safety issue: Yes ]
    Scorings of SAS by patient herself
  • SAS scorings [ Time Frame: 30 min postoperation ] [ Designated as safety issue: Yes ]
    Scorings of SAS by the patient herself
Not Provided
Not Provided
 
Effect of Psychological Interventions on Maternal Outcomes Undergoing Cesarean
Effect of Perioperative Psychological Interventions on Maternal Outcomes Undergoing Cesarean Delivery

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Supportive Care
Perioperative Psychology
  • Other: Language
    Plain language without psychological intervention
  • Other: Language
    Psychological linguistic intervention will be given
    Other Name: Psycholinguistic
  • Sham Comparator: Plain language
    Conventional plain language will be given without any psychological intervention
    Intervention: Other: Language
  • Active Comparator: Pre-psycho-language
    Prior surgery psychological linguistic intervention
    Intervention: Other: Language
  • Active Comparator: Intra-psycho-language
    Intraoperative psychological linguistic intervention
    Intervention: Other: Language
  • Active Comparator: Post-psycho-language
    Postoperative psychological linguistic intervention
    Intervention: Other: Language
  • Active Comparator: Combined language
    Psychological linguistic intervention will be given in a combination of pre-, intra- and post-operatively
    Intervention: Other: Language
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
365
August 2010
August 2010   (final data collection date for primary outcome measure)

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
Female
19 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01141010
NJFY1021005, 10NJMS067
Yes
DongYing Fu, Nanjing Maternity and Child Health Care Hospital
Nanjing Medical University
Confidential Enquiry into Maternal and Child Health
Study Director: DongYing Fu, MSc Nanjing Medical University
Nanjing Medical University
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP