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Recruiting NCT05182541

Psychological Screening and Nursing of Twin Pregnancy

No phase Interventional Twin; Complicating Pregnancy Psychology

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Guided self help, Problem solving therapy, Face to face PST course, Professional psychological intervention.
Who it may be relevant to
Registry conditions: Twin; Complicating Pregnancy, Psychology. Basic parameters: 18 years — 50 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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

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.

Interventions

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

Primary outcome measures

  • Pregnancy stress scale Self rating Anxiety Scale Depression self rating scale（PPS/SAS/SDS） [Time frame: pregnancy 6-14 week]
  • Self-rating Anxiety Scale (SAS) [Time frame: pregnancy 6-14 week]
  • Self-rating Depression Scale (SDS) [Time frame: pregnancy 6-14 week]
Secondary outcome measures (5)
  • Self-rating Anxiety Scale (SAS) [Time frame: 28-37 weeks; after delivery 1 month]
  • Self-rating Depression Scale (SDS) [Time frame: 28-37 weeks; after delivery 1 month]
  • Pregnancy stress scale [Time frame: 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]
  • Weight in kilogram of neonate [Time frame: At birth of neonate]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

China · 1 center
  • Shengjing Hospital Affiliated to China Medical University — Shenyang

Identifiers

NCT: NCT05182541 · PST in TP

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗