Twin; Complicating PregnancyNCT05182541
Psychological Screening and Nursing of Twin Pregnancy
A study testing Guided self help, Problem solving therapy and Face to face PST course in people with Twin; Complicating Pregnancy and Psychology, run by Shengjing Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Twin; Complicating Pregnancy, Psychology
- What is being tested?
- Guided self help, Problem solving therapy and Face to face PST course
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2021to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Pregnancy complicated with severe physical diseases;
- Drop out of this study due to various reasons (including abortion, unwilling to participate in this study)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shengjing Hospital Affiliated to China Medical University
Shenyang, Liaoning, 110004
Tong Jing, undergraduate, 18940259117, jingtong9117@163.com
About this study
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.
Read the 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
- 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.
- Conditions
- Twin; Complicating Pregnancy, Psychology
- Being tested
- Guided self help, Problem solving therapy, Face to face PST course, Professional psychological intervention
- Keywords
- Twin pregnancy, Psychological screening, nursing
- Medical subject headings
- Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided self helpOther
Introduce the knowledge about twins pregnancy, and reduce the pregnant stress, and relief the anxiety and depressor.
Problem solving therapyOther
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 courseOther
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 interventionOther
The mental health physicians and (or) psychological counselors strengthened the intervention and carried out specialized nursing
| Study group | Role | What they receive |
|---|---|---|
| Guided self help | Experimental | Introduce the knowledge about twins pregnancy, and reduce the pregnant stress, and relief the anxiety and depressor. Receives: Other: Guided self help; Other: Problem solving therapy |
| Face to face PST course | Experimental | Problem cognition and emotional response guidance Receives: Other: Problem solving therapy; Other: Face to face PST course |
| Professional psychological intervention | Experimental | Give the pregnancy woman the professional psychological intervention Receives: Other: Professional psychological intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Measured: pregnancy 6-14 week
Secondary outcomes (5)
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 28-37 weeks; after delivery 1 month
Weight in kilogram of neonate
measured by nurses
Measured: At birth of neonate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start1 Mar 2021
- Primary completion1 Jul 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Twin; Complicating PregnancyStudies of the same condition, open and under way.
- More trials run by Shengjing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- China Medical University, China
- Responsible party
- Principal investigator, Caixia Liu, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05182541
- Sponsor's protocol ID
- PST in TP
- Status last verified
- Jan 2022
- First submitted
- 27 Jun 2021
- Last updated
- 19 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Research results and conclusions
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Screening and Nursing of Twin Pregnancy
- ClinicalTrials.gov ID
- NCT05182541
- Acronym / sponsor ID
- PST in TP
- Conditions
- Twin; Complicating Pregnancy, Psychology
- Keywords
- Twin pregnancy, Psychological screening, nursing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Collaborators
- China Medical University, China
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Guided self help | Experimental | Other: Guided self help, Other: Problem solving therapyIntroduce the knowledge about twins pregnancy, and reduce the pregnant stress, and relief the anxiety and depressor. |
| Face to face PST course | Experimental | Other: Problem solving therapy, Other: Face to face PST courseProblem cognition and emotional response guidance |
| Professional psychological intervention | Experimental | Other: Professional psychological interventionGive the pregnancy woman the professional psychological intervention |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Pregnancy complicated with severe physical diseases;
- Drop out of this study due to various reasons (including abortion, unwilling to participate in this study)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guided self helpIntroduce the knowledge about twins pregnancy, and reduce the pregnant stress, and relief the anxiety and depressor. | Other | Guided self help |
| Problem solving therapyBased 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, Guided self help |
| Face to face PST courseFace 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 | Face to face PST course |
| Professional psychological interventionThe mental health physicians and (or) psychological counselors strengthened the intervention and carried out specialized nursing | Other | Professional psychological intervention |
Primary outcome
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
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.
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
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2022.
- Individual participant dataSharing planned: No. Research results and conclusions
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Twin Pregnancy Cohort
Pregnant With Complication, Twin Pregnancy With Antenatal Problem
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Database of Monochorionic Pregnancies
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided self help, Problem solving therapy and Face to face PST course in people with Twin; Complicating Pregnancy and Psychology, run by Shengjing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cunling Xia, Master (18940251368, 18940251368@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy stress scale Self rating Anxiety Scale Depression self rating scale（PPS/SAS/SDS） (time frame: pregnancy 6-14 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2022.