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

Nanjing Medical University

Status: Completed

Conditions: Perioperative Psychology

Treatments: Other: Language

Study type: Interventional

Funder types: Other

Identifiers

NCT01141010

NJFY1021005

10NJMS067 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 365 patients

Sex: Female

Ages: 19 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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365 participants in 5 patient groups

Plain language

Sham Comparator group

Description:

Conventional plain language will be given without any psychological intervention

Treatment:

Other: Language

Other: Language

Pre-psycho-language

Active Comparator group

Description:

Prior surgery psychological linguistic intervention

Treatment:

Other: Language

Other: Language

Intra-psycho-language

Active Comparator group

Description:

Intraoperative psychological linguistic intervention

Treatment:

Other: Language

Other: Language

Post-psycho-language

Active Comparator group

Description:

Postoperative psychological linguistic intervention

Treatment:

Other: Language

Other: Language

Combined language

Active Comparator group

Description:

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

Treatment:

Other: Language

Other: Language