Psychological Screening and Nursing of Twin Pregnancy

Psychology Clinical Trial

Official title:

Psychological Screening and Nursing of Twin Pregnancy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05182541
• Other study ID #: PST in TP
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: December 31, 2026

Study information

• Verified date: January 2022
• Source: Shengjing Hospital
• Contact: Cunling Xia, Master
• Phone: 18940251368
• Email: 18940251368[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2026
• Est. primary completion date: July 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Pregnancy Complications
• Psychology
• Twin; Complicating Pregnancy

Intervention

Other:
• Guided self help
Introduce the knowledge about twins pregnancy, and reduce the pregnant stress, and relief the anxiety and depressor.
• 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
• 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.
• Professional psychological intervention
The mental health physicians and (or) psychological counselors strengthened the intervention and carried out specialized nursing

Locations

Country	Name	City	State
China	Shengjing Hospital Affiliated to China Medical University	Shenyang	Liaoning

Sponsors (2)

Lead Sponsor	Collaborator
Shengjing Hospital	China Medical University, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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.	28-37 weeks; after delivery 1 month
Secondary	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	28-37 weeks; after delivery 1 month
Secondary	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	28-37 weeks; after delivery 1 month
Secondary	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	28-37 weeks; after delivery 1 month
Secondary	Weight in kilogram of neonate	measured by nurses	At birth of neonate