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

August 24, 2010 updated by: Nanjing Medical University

Effect of Perioperative Psychological Interventions on Maternal Outcomes Undergoing Cesarean Delivery

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
365

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Sham Comparator: Plain language
Conventional plain language will be given without any psychological intervention
Other: Language
Plain language without psychological intervention
Other: Language
Psychological linguistic intervention will be given
Other Names:
  • Psycholinguistic
Active Comparator: Pre-psycho-language
Prior surgery psychological linguistic intervention
Other: Language
Plain language without psychological intervention
Other: Language
Psychological linguistic intervention will be given
Other Names:
  • Psycholinguistic
Active Comparator: Intra-psycho-language
Intraoperative psychological linguistic intervention
Other: Language
Plain language without psychological intervention
Other: Language
Psychological linguistic intervention will be given
Other Names:
  • Psycholinguistic
Active Comparator: Post-psycho-language
Postoperative psychological linguistic intervention
Other: Language
Plain language without psychological intervention
Other: Language
Psychological linguistic intervention will be given
Other Names:
  • Psycholinguistic
Active Comparator: Combined language
Psychological linguistic intervention will be given in a combination of pre-, intra- and post-operatively
Other: Language
Plain language without psychological intervention
Other: Language
Psychological linguistic intervention will be given
Other Names:
  • Psycholinguistic

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Self anxiety assessment scale (SAS)
Time Frame: One day prior surgery
Scorings of SAS evaluation by the patient herself
One day prior surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Self depression assessment scale (SDS)
Time Frame: One day prior surgery
Scorings of SDS by the patient herself
One day prior surgery
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
Five min before surgery (-5 min)
Saliva cortisol level
Time Frame: One day prior surgery
Saliva cortisol levels will be measured with EIA
One day prior surgery
Vital signs
Time Frame: One day prior surgery
Blood pressure, heart rate, respiratory rate, oral temperature
One day prior surgery
SAS scorings
Time Frame: 15 min intraoperation
Scorings of SAS by patient herself
15 min intraoperation
SAS scorings
Time Frame: 30 min postoperation
Scorings of SAS by the patient herself
30 min postoperation
SDS scoring
Time Frame: 15 min intraoperation
Scorings of SDS by patient herself
15 min intraoperation
SDS scoring
Time Frame: 30 min postoperation
Scorings of SDS by patient herself
30 min postoperation
VAS pain scoring
Time Frame: Immediately of surgery (0 min)
VAS scorings of pain by a 100 mm scale
Immediately of surgery (0 min)
VAS pain scoring
Time Frame: 5 min after surgery begin (+5 min)
Scorings of VAS pain by a 100 mm scale
5 min after surgery begin (+5 min)
VAS pain scoring
Time Frame: Immediately at the end of surgery (this time changed individually)
Scorings of VAS pain by a 100 mm scale
Immediately at the end of surgery (this time changed individually)
VAS pain scoring
Time Frame: 3 h after surgery
Scorings of VAS pain by a 100 mm scale
3 h after surgery
Saliva cortisol level
Time Frame: 15 min intraoperation
Saliva cortisol level will be measured with EIA
15 min intraoperation
Saliva cortisol level
Time Frame: 30 min postoperation
Saliva cortisol level will be measured with EIA
30 min postoperation
Vital signs
Time Frame: 15 min intraoperation
Blood pressure, heart rate, respiratory rate, oral temperature
15 min intraoperation
Vital signs
Time Frame: 30 min postoperation
Blood pressure, heart rate, respiratory rate, oral temperature
30 min postoperation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nanjing Medical University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Confidential Enquiry into Maternal and Child Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: DongYing Fu, MSc, Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 3, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 10, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 25, 2010

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2010

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NJFY1021005
  • 10NJMS067 (Other Grant/Funding Number: Nanjing Municipal Bureau of Health)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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