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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
  Purpose

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.


Condition Intervention
Perioperative Psychology
Other: Language

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effect of Perioperative Psychological Interventions on Maternal Outcomes Undergoing Cesarean Delivery

Resource links provided by NLM:


Further study details as provided by Nanjing Medical University:

Primary Outcome Measures:
  • Self anxiety assessment scale (SAS) [ Time Frame: One day prior surgery ] [ Designated as safety issue: Yes ]
    Scorings of SAS evaluation by the patient herself


Secondary Outcome Measures:
  • 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


Enrollment: 365
Study Start Date: May 2010
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Plain language
Conventional plain language will be given without any psychological intervention
Other: Language
Plain language without psychological intervention
Active Comparator: Pre-psycho-language
Prior surgery psychological linguistic intervention
Other: Language
Psychological linguistic intervention will be given
Other Name: Psycholinguistic
Active Comparator: Intra-psycho-language
Intraoperative psychological linguistic intervention
Other: Language
Psychological linguistic intervention will be given
Other Name: Psycholinguistic
Active Comparator: Post-psycho-language
Postoperative psychological linguistic intervention
Other: Language
Psychological linguistic intervention will be given
Other Name: Psycholinguistic
Active Comparator: Combined language
Psychological linguistic intervention will be given in a combination of pre-, intra- and post-operatively
Other: Language
Psychological linguistic intervention will be given
Other Name: Psycholinguistic

  Eligibility

Ages Eligible for Study:   19 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01141010

Locations
China, Jiangsu
Nanjing Maternity and Child Health Care Hospital
Nanjing, Jiangsu, China, 210004
Sponsors and Collaborators
Nanjing Medical University
Confidential Enquiry into Maternal and Child Health
Investigators
Study Director: DongYing Fu, MSc Nanjing Medical University
  More Information

No publications provided

Responsible Party: DongYing Fu, Nanjing Maternity and Child Health Care Hospital
ClinicalTrials.gov Identifier: NCT01141010     History of Changes
Other Study ID Numbers: NJFY1021005, 10NJMS067
Study First Received: June 3, 2010
Last Updated: August 24, 2010
Health Authority: China: Nanjing Municipal Bureau of Health
China: Nanjing Medical University

Keywords provided by Nanjing Medical University:
Linguistic
Stress response
Corticosteroid
Cesarean section
Anxiety
Depression
Maternal psychosis

ClinicalTrials.gov processed this record on November 20, 2014