Psychological Screening and Nursing of Twin Pregnancy
Primary Purpose
Twin; Complicating Pregnancy, Psychology
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Guided self help
Problem solving therapy
Face to face PST course
Professional psychological intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Twin; Complicating Pregnancy focused on measuring Twin pregnancy, Psychological screening, nursing
Eligibility Criteria
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)
Sites / Locations
- Shengjing Hospital Affiliated to China Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Guided self help
Face to face PST course
Professional psychological intervention
Arm Description
Introduce the knowledge about twins pregnancy, and reduce the pregnant stress, and relief the anxiety and depressor.
Problem cognition and emotional response guidance
Give the pregnancy woman the professional psychological intervention
Outcomes
Primary Outcome Measures
Pregnancy stress scale Self rating Anxiety Scale Depression self rating scale(PPS/SAS/SDS)
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
Self-rating Anxiety Scale (SAS)
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.
Self-rating Depression Scale (SDS)
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
Secondary Outcome Measures
Self-rating Anxiety Scale (SAS)
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.
Self-rating Depression Scale (SDS)
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 stress scale
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
Gestational age and prolongation of gestational age at delivery
Gestational age at which symptoms of preterm birth occur and gestational age at delivery after treatment
Weight in kilogram of neonate
measured by nurses
Full Information
NCT ID
NCT05182541
First Posted
June 27, 2021
Last Updated
January 17, 2022
Sponsor
Shengjing Hospital
Collaborators
China Medical University, China
1. Study Identification
Unique Protocol Identification Number
NCT05182541
Brief Title
Psychological Screening and Nursing of Twin Pregnancy
Official Title
Psychological Screening and Nursing of Twin Pregnancy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
July 1, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shengjing Hospital
Collaborators
China Medical University, China
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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
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
The evaluation indexes included PPS / SAS / SDS, incidence of preterm birth, premature rupture of membranes and blood pressure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Twin; Complicating Pregnancy, Psychology
Keywords
Twin pregnancy, Psychological screening, nursing
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Guided self help
Arm Type
Experimental
Arm Description
Introduce the knowledge about twins pregnancy, and reduce the pregnant stress, and relief the anxiety and depressor.
Arm Title
Face to face PST course
Arm Type
Experimental
Arm Description
Problem cognition and emotional response guidance
Arm Title
Professional psychological intervention
Arm Type
Experimental
Arm Description
Give the pregnancy woman the professional psychological intervention
Intervention Type
Other
Intervention Name(s)
Guided self help
Intervention Description
Introduce the knowledge about twins pregnancy, and reduce the pregnant stress, and relief the anxiety and depressor.
Intervention Type
Other
Intervention Name(s)
Problem solving therapy
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Face to face PST course
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Professional psychological intervention
Intervention Description
The mental health physicians and (or) psychological counselors strengthened the intervention and carried out specialized nursing
Primary Outcome Measure Information:
Title
Pregnancy stress scale Self rating Anxiety Scale Depression self rating scale(PPS/SAS/SDS)
Description
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
Time Frame
pregnancy 6-14 week
Title
Self-rating Anxiety Scale (SAS)
Description
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.
Time Frame
pregnancy 6-14 week
Title
Self-rating Depression Scale (SDS)
Description
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
Time Frame
pregnancy 6-14 week
Secondary Outcome Measure Information:
Title
Self-rating Anxiety Scale (SAS)
Description
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.
Time Frame
28-37 weeks; after delivery 1 month
Title
Self-rating Depression Scale (SDS)
Description
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
Time Frame
28-37 weeks; after delivery 1 month
Title
Pregnancy stress scale
Description
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
Time Frame
28-37 weeks; after delivery 1 month
Title
Gestational age and prolongation of gestational age at delivery
Description
Gestational age at which symptoms of preterm birth occur and gestational age at delivery after treatment
Time Frame
28-37 weeks; after delivery 1 month
Title
Weight in kilogram of neonate
Description
measured by nurses
Time Frame
At birth of neonate
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cunling Xia, Master
Phone
18940251368
Email
18940251368@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Caixia Liu, Master
Phone
18940251716
Email
Liucx1716@163.com
Facility Information:
Facility Name
Shengjing Hospital Affiliated to China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tong Jing, undergraduate
Phone
18940259117
Email
jingtong9117@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Research results and conclusions
Learn more about this trial
Psychological Screening and Nursing of Twin Pregnancy
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