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.

Study Overview

• Status: Recruiting
• Conditions: Twin; Complicating Pregnancy; Psychology
• Intervention / Treatment: Other: Guided self help; Other: Problem solving therapy; Other: Face to face PST course; Other: Professional psychological intervention

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cunling Xia, Master; Phone Number: 18940251368; Email: 18940251368@163.com
• Study Contact Backup: Name: Caixia Liu, Master; Phone Number: 18940251716; Email: Liucx1716@163.com

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China, 110004
      • Recruiting
      • Shengjing Hospital affiliated to China Medical University
      • Contact: Tong Jing, undergraduate; Phone Number: 18940259117; Email: jingtong9117@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Guided self help; Introduce the knowledge about twins pregnancy, and reduce the pregnant stress, and relief the anxiety and depressor.	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
Experimental: Face to face PST course; Problem cognition and emotional response guidance	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.
Experimental: Professional psychological intervention; Give the pregnancy woman the professional psychological intervention	Other: Professional psychological intervention; The mental health physicians and (or) psychological counselors strengthened the intervention and carried out specialized nursing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Weight in kilogram of neonate	measured by nurses	At birth of neonate

Collaborators and Investigators

• Sponsor: Shengjing Hospital
• Collaborators: China Medical University, China

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Anticipated): July 1, 2026
• Study Completion (Anticipated): December 31, 2026

Study Registration Dates

• First Submitted: June 27, 2021
• First Submitted That Met QC Criteria: December 20, 2021
• First Posted (Actual): January 10, 2022

Study Record Updates

• Last Update Posted (Actual): January 19, 2022
• Last Update Submitted That Met QC Criteria: January 17, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: nursing; Twin pregnancy; Psychological screening
• Additional Relevant MeSH Terms: Pregnancy Complications
• Other Study ID Numbers: PST in TP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Research results and conclusions

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No