Effect of stress inoculation training based on the WeChat platform on pregnant women with assisted reproduction
| ISRCTN | ISRCTN52045980 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52045980 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Suzhou Municipal Hospital |
| Funders | Gusu School of Nanjing Medical University, Suzhou Municipal Hospital |
- Submission date
- 21/03/2025
- Registration date
- 27/03/2025
- Last edited
- 26/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
The aim of this study is to find out whether stress inoculation training (SIT) through the WeChat platform can effectively relieve the perinatal psychological pressure of pregnant women undergoing assisted reproduction.
Who can participate?
Pregnant women aged 18-35 years undergoing assisted reproduction (in vitro fertilization-embryo transfer [IVF-ET])
What does the study involve?
Participants are randomly divided into the control group and the experimental group. The control group was given routine nursing intervention and the experimental group was given SIT based on the WeChat platform.
What are the possible benefits and risks of participating?
SIT may relieve the perinatal psychological pressure of pregnant women with assisted reproduction, relieve the tension during delivery, increase the natural delivery rate and reduce the incidence of premature delivery.
Where is the study run from?
Suzhou Municipal Hospital (China)
When is the study starting and how long is it expected to run for?
September 2022 to October 2023
Who is funding the study?
1. Gusu School of Nanjing Medical University (China)
2. Suzhou Municipal Hospital (China)
Who is the main contact?
Jia Liu, fngsajia@126.com
Contact information
Public, Scientific, Principal investigator
No. 458 Shizi Street
Gusu District
Suzhou
215006
China
 ORCID ID |
0000-0002-6646-8787 |
|---|---|
| Phone | +86 (0)13584890104 |
| fngsajia@126.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-center interventional double-blinded randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Effect of stress inoculation training based on the WeChat platform on perinatal psychological stress and delivery outcome of pregnant women with assisted reproduction |
| Study objectives | Stress inoculation training (SIT) can effectively relieve the perinatal psychological pressure of pregnant women with assisted reproduction, relieve the tension during delivery, increase the natural delivery rate and reduce the incidence of premature delivery. |
| Ethics approval(s) |
Approved 24/09/2022, The ethics committee of Suzhou Municipal Hospital (No. 26 Daoqian Street, Gusu District, Suzhou, 215002, China; +86 (0)51262362550; webmaster@smh.cc), ref: K-2022-103-H01 |
| Health condition(s) or problem(s) studied | Perinatal psychological stress and delivery outcome of pregnant women with assisted reproduction |
| Intervention | 110 pregnant women who have In Vitro Fertilization-Embryo Transfer (IVF-ET) will be randomly divided into a control group and an experimental group with 55 cases in each group. The control group will be given routine nursing intervention and the experimental group will be given SIT based on the WeChat platform. Patients in the control group received routine early pregnancy health guidance and psychological screening. At 13 + 6 weeks of gestation, the control group filled in the demographic data questionnaire, including age, height, weight, residence during pregnancy, occupation, education, monthly family income, medical expenses, pregnancy history, etc.. After scanning the QR code, the Edinburgh postnatal depression scale (EPDS) and State-Trait Anxiety Inventory (STAI) were completed in the questionnaire star, and routine early pregnancy health guidance was given. At 24-27 + 6 weeks of gestation, patients attend school courses for pregnant women, including diet during pregnancy, self-monitoring of fetal movement, pregnancy activities and weight management, and distribute health education materials. At 28-37 weeks of gestation, patients attend the simulated delivery training courses, regular pre-delivery guidance. At 32 weeks and 37 weeks of gestation, one-to-one perinatal consultation and guidance were conducted in the midwife clinic. After 37 weeks of pregnancy, the psychological stress of the control group was assessed again, and the EPDS and STAI questionnaires were completed in the questionnaire star. In addition to routine early pregnancy health guidance and psychological screening, patients in the intervention group were given SIT. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Psychological stress is measured using the WeChat version of the psychological questionnaire before and after the study |
| Key secondary outcome measure(s) |
The rate of natural delivery is measured using the delivery records in the hospital before and after the study |
| Completion date | 01/10/2023 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 35 Years |
| Sex | Female |
| Target sample size at registration | 120 |
| Total final enrolment | 110 |
| Key inclusion criteria | 1. Age ≥18 years 2. Infertility patients who had undergone IVF-ET and successfully conceived 3. Permanent residents in the area surveyed 4. Regular antenatal examination, cooperation with training and completion of questionnaire survey 5. Voluntary participation, and signed the informed consent 6. Individuals who can fully understand or accurately answer the questionnaire questions |
| Key exclusion criteria | 1. Patients with severe depression and anxiety 2. Patients with severe basic diseases such as heart, lung and immunity 3. Patients with mental retardation 4. Patients with mental retardation, failure to cooperate and complete all investigations |
| Date of first enrolment | 25/09/2022 |
| Date of final enrolment | 30/09/2022 |
Locations
Countries of recruitment
- China
Study participating centre
Gusu District
Suzhou
215002
China
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to ethical restrictions. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
21/03/2025: Study's existence confirmed by the ethics committee of Suzhou Municipal Hospital.
