Effect of Psychological Interventions on Maternal Outcomes Undergoing Cesarean - Full Text View

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:

MedlinePlus related topics: Anxiety Cesarean Section Depression Mental Disorders Psychotic Disorders

U.S. FDA Resources

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

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 May 23, 2013

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