Psychological Screening and Nursing of Twin Pregnancy

January 17, 2022 updated by: Caixia Liu, Shengjing Hospital
Objectives This research will screen the psychological problems of twin pregnant women step by step and detect early and treat early in order to reduce the incidence of mental diseases and promote the health of mother and baby.

Study Overview

Status

Status

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

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.

Detailed Description

Method Twin pregnant women recruited for the study.The two groups were given routine treatment and nursing measures. The trained group members were given routine psychological care to the control group, while the intervention group was given step-by-step psychological care at the same time.

Evaluate the effect

  1. Evaluation methods include process evaluation and result evaluation. Process assessment means that the researchers use the pregnancy stress scale, self rating depression scale and self rating anxiety scale to assess the stress, anxiety and depression of patients at different stages, and make intervention decisions according to the score results; Results evaluation means that if the intervention is effective at a certain stage, the researcher can use it again
  2. The evaluation indexes included PPS / SAS / SDS, incidence of preterm birth, premature rupture of membranes and blood pressure.

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 (Anticipated)

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.
100

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 110004
        • Recruiting
        • Shengjing Hospital Affiliated to China Medical University
        • Contact:

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

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Clinical diagnosis of intrauterine twin pregnancy.
  • The patients whose psychological screening scale score reached the critical value (pregnancy stress scale >50 and/or Self rating depression scale ≥ 40 and/or The self rating Anxiety Scale (SAS) was more than 50.
  • The outpatient department of the research hospital was established and antenatal examination was carried out regularly.
  • No mental and communication disorders (including depression and other mental diseases).
  • Voluntary participation in this study

Exclusion Criteria:

  • Pregnancy complicated with severe physical diseases;
  • Drop out of this study due to various reasons (including abortion, unwilling to participate in this study)

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: Single

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.
Experimental: Guided self help
Introduce the knowledge about twins pregnancy, and reduce the pregnant stress, and relief the anxiety and depressor.
Other: Guided self help
Introduce the knowledge about twins pregnancy, and reduce the pregnant stress, and relief the anxiety and depressor.
Other: Problem solving therapy
Based on the steps of problem-solving therapy, nurses guide mothers with mild psychological problems to solve the existing problems through wechat and telephone, 10-15 min each time for 4 weeks
Experimental: Face to face PST course
Problem cognition and emotional response guidance
Other: Problem solving therapy
Based on the steps of problem-solving therapy, nurses guide mothers with mild psychological problems to solve the existing problems through wechat and telephone, 10-15 min each time for 4 weeks
Other: Face to face PST course
Face to face interviews with nurses with psychological counselors, combined with auxiliary tools, identify patients' problems, set goals for patients, provide different solutions, and let patients choose appropriate ways according to their preferences. Once a week, 1 hour for the first time and 45 min for the rest for 5 weeks.
Experimental: Professional psychological intervention
Give the pregnancy woman the professional psychological intervention
Other: Professional psychological intervention
The mental health physicians and (or) psychological counselors strengthened the intervention and carried out specialized nursing

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
Pregnancy stress scale Self rating Anxiety Scale Depression self rating scale（PPS/SAS/SDS）
Time Frame: pregnancy 6-14 week
If scores are less than 50, it is defined as normal; If scores are 50-59, it is defined as mild pregnancy stress; If scores are 60-69, it is defined as moderate pressure; If scores are ≥70, it is defined as severe pregnancy stress
pregnancy 6-14 week
Self-rating Anxiety Scale (SAS)
Time Frame: pregnancy 6-14 week
If scores are less than 50, it is defined as normal; If scores are 50-59, it is defined as mild anxiety; If scores are 60-69, it is defined as moderate anxiety; If scores are ≥70, it is defined as severe anxiety.
pregnancy 6-14 week
Self-rating Depression Scale (SDS)
Time Frame: pregnancy 6-14 week
If scores are less than 50, it is defined as normal; If scores are 50-59, it is defined as mild depression; If scores are 60-69, it is defined as moderate depression; If scores are ≥70, it is defined as severe depression
pregnancy 6-14 week

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-rating Anxiety Scale (SAS)
Time Frame: 28-37 weeks; after delivery 1 month
If scores are less than 50, it is defined as normal; If scores are 50-59, it is defined as mild anxiety; If scores are 60-69, it is defined as moderate anxiety; If scores are ≥70, it is defined as severe anxiety.
28-37 weeks; after delivery 1 month
Self-rating Depression Scale (SDS)
Time Frame: 28-37 weeks; after delivery 1 month
If scores are less than 50, it is defined as normal; If scores are 50-59, it is defined as mild depression; If scores are 60-69, it is defined as moderate depression; If scores are ≥70, it is defined as severe depression
28-37 weeks; after delivery 1 month
Pregnancy stress scale
Time Frame: 28-37 weeks; after delivery 1 month
If scores are less than 50, it is defined as normal; If scores are50-59, it is defined as mild pregnancy stress; If scores are 60-69, it is defined as moderate pressure; If scores are ≥70, it is defined as severe pregnancy stress
28-37 weeks; after delivery 1 month
Gestational age and prolongation of gestational age at delivery
Time Frame: 28-37 weeks; after delivery 1 month
Gestational age at which symptoms of preterm birth occur and gestational age at delivery after treatment
28-37 weeks; after delivery 1 month
Weight in kilogram of neonate
Time Frame: At birth of neonate
measured by nurses
At birth of neonate

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.
Shengjing Hospital

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.
China Medical University, China

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 (Actual)

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.
March 1, 2021

Primary Completion (Anticipated)

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.
July 1, 2026

Study Completion (Anticipated)

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.
December 31, 2026

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 27, 2021

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.
December 20, 2021

First Posted (Actual)

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.
January 10, 2022

Study Record Updates

Last Update Posted (Actual)

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.
January 19, 2022

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.
January 17, 2022

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.
January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • PST in TP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Research results and conclusions

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings