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Effect of Psychological Interventions on Maternal Outcomes Undergoing Cesarean

Effect of Perioperative Psychological Interventions on Maternal Outcomes Undergoing Cesarean Delivery

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01141010
Acronym
PIMAC
Enrollment
365
Registered
2010-06-10
Start date
2010-05-31
Completion date
2010-08-31
Last updated
2010-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perioperative Psychology

Keywords

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

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.

Interventions

OTHERLanguage

Plain language without psychological intervention

Sponsors

Confidential Enquiry into Maternal and Child Health
CollaboratorOTHER
Nanjing Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
19 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Self anxiety assessment scale (SAS)One day prior surgeryScorings of SAS evaluation by the patient herself

Secondary

MeasureTime frameDescription
Visual analog scale of pain (VAS pain)Five min before surgery (-5 min)Patient self assessed pain scorings with a 100 mm (0-100) scale
Saliva cortisol levelOne day prior surgerySaliva cortisol levels will be measured with EIA
Vital signsOne day prior surgeryBlood pressure, heart rate, respiratory rate, oral temperature
Self depression assessment scale (SDS)One day prior surgeryScorings of SDS by the patient herself
SDS scoring15 min intraoperationScorings of SDS by patient herself
VAS pain scoringImmediately of surgery (0 min)VAS scorings of pain by a 100 mm scale
SAS scorings15 min intraoperationScorings of SAS by patient herself

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026