CClinicalTrials.gg
CompletedNCT01141010PIMACUpdated Aug 25, 2010

Effect of Psychological Interventions on Maternal Outcomes Undergoing Cesarean

An interventional study of Language and Language in Perioperative Psychology, sponsored by Nanjing Medical University. Completed at 1 site in China. Open to female participants aged 19 Years to 50 Years. Per ClinicalTrials.gov, last updated 2010-08-25.

Sponsored by Nanjing Medical University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
365
Allocation
Randomized
Ages
19 Years to 50 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Perioperative Psychology

Keywords

  • Linguistic
  • Stress response
  • Corticosteroid
  • Cesarean section
  • Anxiety
  • Depression
  • Maternal psychosis
03

In context

Lead sponsor

Nanjing Medical University is the lead sponsor of 169 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
365 participants (actual)

Study arms

  • Sham comparator
    Plain language

    Conventional plain language will be given without any psychological intervention

    Other: Language

  • Active comparator
    Pre-psycho-language

    Prior surgery psychological linguistic intervention

    Other: Language

  • Active comparator
    Intra-psycho-language

    Intraoperative psychological linguistic intervention

    Other: Language

  • Active comparator
    Post-psycho-language

    Postoperative psychological linguistic intervention

    Other: Language

  • Active comparator
    Combined language

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

    Other: Language

Interventions

  • OtherLanguage

    Plain language without psychological intervention

  • OtherLanguage

    Psychological linguistic intervention will be given

    Also known as: Psycholinguistic

06

What researchers measure

Primary outcomes

  1. Self anxiety assessment scale (SAS)

    Scorings of SAS evaluation by the patient herself

    Time frame: One day prior surgery

Secondary outcomes

  1. Self depression assessment scale (SDS)

    Scorings of SDS by the patient herself

    Time frame: One day prior surgery

  2. Visual analog scale of pain (VAS pain)

    Patient self assessed pain scorings with a 100 mm (0-100) scale

    Time frame: Five min before surgery (-5 min)

  3. Saliva cortisol level

    Saliva cortisol levels will be measured with EIA

    Time frame: One day prior surgery

  4. Vital signs

    Blood pressure, heart rate, respiratory rate, oral temperature

    Time frame: One day prior surgery

  5. SAS scorings

    Scorings of SAS by patient herself

    Time frame: 15 min intraoperation

  6. SAS scorings

    Scorings of SAS by the patient herself

    Time frame: 30 min postoperation

  7. SDS scoring

    Scorings of SDS by patient herself

    Time frame: 15 min intraoperation

  8. SDS scoring

    Scorings of SDS by patient herself

    Time frame: 30 min postoperation

  9. VAS pain scoring

    VAS scorings of pain by a 100 mm scale

    Time frame: Immediately of surgery (0 min)

  10. VAS pain scoring

    Scorings of VAS pain by a 100 mm scale

    Time frame: 5 min after surgery begin (+5 min)

  11. VAS pain scoring

    Scorings of VAS pain by a 100 mm scale

    Time frame: Immediately at the end of surgery (this time changed individually)

  12. VAS pain scoring

    Scorings of VAS pain by a 100 mm scale

    Time frame: 3 h after surgery

  13. Saliva cortisol level

    Saliva cortisol level will be measured with EIA

    Time frame: 15 min intraoperation

  14. Saliva cortisol level

    Saliva cortisol level will be measured with EIA

    Time frame: 30 min postoperation

  15. Vital signs

    Blood pressure, heart rate, respiratory rate, oral temperature

    Time frame: 15 min intraoperation

  16. Vital signs

    Blood pressure, heart rate, respiratory rate, oral temperature

    Time frame: 30 min postoperation

07

Study locations

1 site
  • Nanjing Maternity and Child Health Care Hospital
    Nanjing, Jiangsu 210004, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 25, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01141010
Lead sponsor
Nanjing Medical University
Collaborators
Confidential Enquiry into Maternal and Child Health
First posted
Jun 10, 2010
Start date
May 2010
Primary completion
Aug 2010
Completion
Aug 2010
Last update
Aug 25, 2010

Study contacts

DongYing Fu, MSc
study director · Nanjing Medical University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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