Psychological Screening and Nursing of Twin Pregnancy

NCT05182541 | Recruiting DMC

• 1 other identifier: PST in TP
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Twin; Complicating Pregnancy; Psychology

Keywords

Twin pregnancy; Psychological screening; nursing

Outcome Measures

Primary Outcomes (3)

• 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

  pregnancy 6-14 week

• 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.

  pregnancy 6-14 week

• 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 6-14 week

Secondary Outcomes (5)

• Self-rating Anxiety Scale (SAS)

  28-37 weeks; after delivery 1 month

• Self-rating Depression Scale (SDS)

  28-37 weeks; after delivery 1 month

• Pregnancy stress scale

  28-37 weeks; after delivery 1 month

• Gestational age and prolongation of gestational age at delivery

  28-37 weeks; after delivery 1 month

• Weight in kilogram of neonate

  At birth of neonate

Study Arms (3)

Guided self help

EXPERIMENTAL

Introduce the knowledge about twins pregnancy, and reduce the pregnant stress, and relief the anxiety and depressor.

Other: Guided self help; Other: Problem solving therapy

Face to face PST course

EXPERIMENTAL

Problem cognition and emotional response guidance

Other: Problem solving therapy; Other: Face to face PST course

Professional psychological intervention

EXPERIMENTAL

Give the pregnancy woman the professional psychological intervention

Other: Professional psychological intervention

Interventions

Guided self help OTHER

Introduce the knowledge about twins pregnancy, and reduce the pregnant stress, and relief the anxiety and depressor.

Guided self help

Problem solving therapy OTHER

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

Face to face PST course; Guided self help

Face to face PST course OTHER

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.

Face to face PST course

Professional psychological intervention OTHER

The mental health physicians and (or) psychological counselors strengthened the intervention and carried out specialized nursing

Professional psychological intervention

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Shengjing Hospital: lead
• China Medical University, China: collaborator

Study Sites (1)

Shengjing Hospital Affiliated to China Medical University

Shenyang, Liaoning, 110004, China

RECRUITING

MeSH Terms

Conditions

Pregnancy Complications

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Cunling Xia, Master

CONTACT

18940251368; 18940251368@163.com

Caixia Liu, Master

CONTACT

18940251716; Liucx1716@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: June 27, 2021
• First Posted: January 10, 2022
• Study Start: March 1, 2021
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 19, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)