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

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.

Study Overview

• Status: Completed
• Conditions: Perioperative Psychology
• Intervention / Treatment: Other: Language; Other: Language

• Study Type: Interventional
• Enrollment (Actual): 365
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210004
      • Nanjing Maternity and Child Health Care Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Plain language; Conventional plain language will be given without any psychological intervention	Other: Language; Plain language without psychological intervention; Other: Language; Psychological linguistic intervention will be given; Other Names: Psycholinguistic
Active Comparator: Pre-psycho-language; Prior surgery psychological linguistic intervention	Other: Language; Plain language without psychological intervention; Other: Language; Psychological linguistic intervention will be given; Other Names: Psycholinguistic
Active Comparator: Intra-psycho-language; Intraoperative psychological linguistic intervention	Other: Language; Plain language without psychological intervention; Other: Language; Psychological linguistic intervention will be given; Other Names: Psycholinguistic
Active Comparator: Post-psycho-language; Postoperative psychological linguistic intervention	Other: Language; Plain language without psychological intervention; Other: Language; Psychological linguistic intervention will be given; Other Names: Psycholinguistic
Active Comparator: Combined language; Psychological linguistic intervention will be given in a combination of pre-, intra- and post-operatively	Other: Language; Plain language without psychological intervention; Other: Language; Psychological linguistic intervention will be given; Other Names: Psycholinguistic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self anxiety assessment scale (SAS)	Scorings of SAS evaluation by the patient herself	One day prior surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self depression assessment scale (SDS)	Scorings of SDS by the patient herself	One day prior surgery
Visual analog scale of pain (VAS pain)	Patient self assessed pain scorings with a 100 mm (0-100) scale	Five min before surgery (-5 min)
Saliva cortisol level	Saliva cortisol levels will be measured with EIA	One day prior surgery
Vital signs	Blood pressure, heart rate, respiratory rate, oral temperature	One day prior surgery
SAS scorings	Scorings of SAS by patient herself	15 min intraoperation
SAS scorings	Scorings of SAS by the patient herself	30 min postoperation
SDS scoring	Scorings of SDS by patient herself	15 min intraoperation
SDS scoring	Scorings of SDS by patient herself	30 min postoperation
VAS pain scoring	VAS scorings of pain by a 100 mm scale	Immediately of surgery (0 min)
VAS pain scoring	Scorings of VAS pain by a 100 mm scale	5 min after surgery begin (+5 min)
VAS pain scoring	Scorings of VAS pain by a 100 mm scale	Immediately at the end of surgery (this time changed individually)
VAS pain scoring	Scorings of VAS pain by a 100 mm scale	3 h after surgery
Saliva cortisol level	Saliva cortisol level will be measured with EIA	15 min intraoperation
Saliva cortisol level	Saliva cortisol level will be measured with EIA	30 min postoperation
Vital signs	Blood pressure, heart rate, respiratory rate, oral temperature	15 min intraoperation
Vital signs	Blood pressure, heart rate, respiratory rate, oral temperature	30 min postoperation

Collaborators and Investigators

• Sponsor: Nanjing Medical University
• Collaborators: Confidential Enquiry into Maternal and Child Health
• Investigators: Study Director: DongYing Fu, MSc, Nanjing Medical University

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: June 3, 2010
• First Submitted That Met QC Criteria: June 9, 2010
• First Posted (Estimate): June 10, 2010

Study Record Updates

• Last Update Posted (Estimate): August 25, 2010
• Last Update Submitted That Met QC Criteria: August 24, 2010
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Keywords: Depression; Anxiety; Cesarean section; Corticosteroid; Linguistic; Stress response; Maternal psychosis
• Other Study ID Numbers: NJFY1021005; 10NJMS067 (Other Grant/Funding Number: Nanjing Municipal Bureau of Health)