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NCT Number: NCT05182541

Psychological Screening and Nursing of Twin Pregnancy

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.

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Key information

Conditions

Twin; Complicating Pregnancy Female Urogenital Diseases and Pregnancy Complications Pregnancy Complications Psychology Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Shengjing Hospital Affiliated to China Medical University

Shenyang, Liaoning, 110004, China

Location status: Recruiting

Location contact

Tong Jing, undergraduate

CONTACT

[email protected]

18940259117

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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)

Treatment and study plan

Guided Self Help

Other

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

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

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.

Professional psychological intervention

Other

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

Primary outcomes

  1. 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

  2. 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.

  3. 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

Secondary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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

  5. Weight in kilogram of neonate

    Time frame: At birth of neonate

    measured by nurses

Study contacts

Contact information is provided by the study sponsor or research team.

Caixia Liu, Master

CONTACT

[email protected]

18940251716

Cunling Xia, Master

CONTACT

[email protected]

18940251368

Sponsors and collaborators

Lead sponsor

Shengjing Hospital

Other

Collaborators

  • China Medical University, China

Registry information

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jan 10, 2022
Registry last updated
Jan 19, 2022

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

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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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