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Completed

NCT Number: NCT01141010

Effect of Psychological Interventions on Maternal Outcomes Undergoing Cesarean

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.

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Key information

Conditions

Perioperative Psychology Anxiety Disorders Behavior Behavioral Symptoms Depression Fractures, Bone Fractures, Stress Mental Disorders Wounds and Injuries

Age range

19 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Nanjing Maternity and Child Health Care Hospital

Nanjing, Jiangsu, 210004, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Language

Other

Plain language without psychological intervention

Primary outcomes

  1. Self anxiety assessment scale (SAS)

    Time frame: One day prior surgery

    Scorings of SAS evaluation by the patient herself

Secondary outcomes

  1. Self depression assessment scale (SDS)

    Time frame: One day prior surgery

    Scorings of SDS by the patient herself

  2. Visual analog scale of pain (VAS pain)

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

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

  3. Saliva cortisol level

    Time frame: One day prior surgery

    Saliva cortisol levels will be measured with EIA

  4. Vital signs

    Time frame: One day prior surgery

    Blood pressure, heart rate, respiratory rate, oral temperature

  5. SAS scorings

    Time frame: 15 min intraoperation

    Scorings of SAS by patient herself

  6. SAS scorings

    Time frame: 30 min postoperation

    Scorings of SAS by the patient herself

  7. SDS scoring

    Time frame: 15 min intraoperation

    Scorings of SDS by patient herself

  8. SDS scoring

    Time frame: 30 min postoperation

    Scorings of SDS by patient herself

  9. VAS pain scoring

    Time frame: Immediately of surgery (0 min)

    VAS scorings of pain by a 100 mm scale

  10. VAS pain scoring

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

    Scorings of VAS pain by a 100 mm scale

  11. VAS pain scoring

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

    Scorings of VAS pain by a 100 mm scale

  12. VAS pain scoring

    Time frame: 3 h after surgery

    Scorings of VAS pain by a 100 mm scale

  13. Saliva cortisol level

    Time frame: 15 min intraoperation

    Saliva cortisol level will be measured with EIA

  14. Saliva cortisol level

    Time frame: 30 min postoperation

    Saliva cortisol level will be measured with EIA

  15. Vital signs

    Time frame: 15 min intraoperation

    Blood pressure, heart rate, respiratory rate, oral temperature

  16. Vital signs

    Time frame: 30 min postoperation

    Blood pressure, heart rate, respiratory rate, oral temperature

Sponsors and collaborators

Lead sponsor

Nanjing Medical University

Other

Collaborators

  • Confidential Enquiry into Maternal and Child Health

Registry information

Official study title

Effect of Perioperative Psychological Interventions on Maternal Outcomes Undergoing Cesarean Delivery

Acronym: PIMAC

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jun 10, 2010
Registry last updated
Aug 25, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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