Effect of Psychological Interventions on Maternal Outcomes Undergoing Cesarean

NCT01141010 | Completed DMC

• 2 other identifiers: NJFY102100510NJMS067
• Study Type: interventional
• Target: 365
• Locations: 1 country
• Sites: 1

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.

Conditions

Perioperative Psychology

Keywords

Linguistic; Stress response; Corticosteroid; Cesarean section; Anxiety; Depression; Maternal psychosis

Outcome Measures

Primary Outcomes (1)

• Self anxiety assessment scale (SAS)

  Scorings of SAS evaluation by the patient herself

  One day prior surgery

Secondary Outcomes (16)

• 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

  One day prior surgery

• Vital signs

  One day prior surgery

• SAS scorings

  15 min intraoperation

Study Arms (5)

Plain language

SHAM COMPARATOR

Conventional plain language will be given without any psychological intervention

Other: Language

Pre-psycho-language

ACTIVE COMPARATOR

Prior surgery psychological linguistic intervention

Other: Language

Intra-psycho-language

ACTIVE COMPARATOR

Intraoperative psychological linguistic intervention

Other: Language

Post-psycho-language

ACTIVE COMPARATOR

Postoperative psychological linguistic intervention

Other: Language

Combined language

ACTIVE COMPARATOR

Psychological linguistic intervention will be given in a combination of pre-, intra- and post-operatively

Other: Language

Interventions

Language OTHER

Plain language without psychological intervention

Plain language

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Chinese gravidas
• Gestational age \>=36 wk
• Nulliparas
• Undergoing selective Cesarean section

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanjing Medical University: lead
• Confidential Enquiry into Maternal and Child Health: collaborator

Study Sites (1)

Nanjing Maternity and Child Health Care Hospital

Nanjing, Jiangsu, 210004, China

Location

MeSH Terms

Conditions

Fractures, Stress; Anxiety Disorders; Depression

Interventions

Psycholinguistics

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavioral Sciences; Behavioral Disciplines and Activities

Study Officials

• DongYing Fu, MSc

  Nanjing Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 3, 2010
• First Posted: June 10, 2010
• Study Start: May 1, 2010
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: August 25, 2010

Record last verified: 2010-08

Locations

CN (1)