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The in vitro fertilization and embryo transfer(IVF-ET) is a therapy to help the infertile couples. The mental health status of couple under IVF-ET, commonly seen in depression and anxiety, is found to be closely related to the success of IVF-ET. This study aims to develop a intervention program combing cognitive psychotherapy and progressive muscle relaxation to ease the negative emotion and promote the success rate among couples undergoing IVF-ET.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Women intervention arm | Experimental | Intervention will be applied to the women within the couple. |
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| Couple intervention arm | Experimental | Intervention will be applied to the couple, both men and women. |
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| Control arm | No Intervention | The couple will receive the normal nursing care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive progressive muscular relaxation therapy | Behavioral | This therapy combines cognitive psychotherapy and progressive muscular relaxation, intervened 6 times with 1-1.5 hour each time. The whole therapy will last round 28-30 days during IVF-ET. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of depression score | The Self-reported Depression Scale （SDS）will be used to assess the score of depression.The total score of SDS ranges from 0-80, with 40 as the cutoff. The higher the total score, the more depressive. | The investigators will measure the socre of depression at baseline and immediately after intervention ( the duration of intervention is around 1 month). |
| Change of anxiety score | The Self-reported Anxiety Scale (SAS) will be used to assess the score of anxiety.The total score of SAS ranges from 0-80, with 30 as the cutoff. The higher the total score, the more anxious. | The investigators will measure the socre of anxiety at baseline and immediately after intervention ( the duration of intervention is around 1 month). |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Blood Cortisol | This is a kind of hormone closely related to stress, and the investigators will measure the level of Blood Cortisol by Blood test. | The investigators will measure the socre of Blood Cortisol at baseline and immediately after intervention ( the duration of intervention is around 1 month). |
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Inclusion Criteria:
Exclusion Criteria:
Biological sex
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Infertility Reproductive Center, Second Xiangya Hospital, Central South University | Changsha | Hunan | 410013 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38647487 | Derived | Wang A, Zhang W, Li H, Guo Y, Yu NX, Zhang J. An 8-week community-based resilience group intervention for Chinese parents who lost their only child: A two-armed pragmatic waitlist-control trial. Psychol Trauma. 2025 Jan;17(1):225-234. doi: 10.1037/tra0001670. Epub 2024 Apr 22. | |
| 38056467 | Derived | Chen D, Wang A, Zhang W, Guo Y, Yao S, Chen X, Zhang J. Effectiveness of double ABCX-based psychotherapy for psychological distress among women undergoing in vitro fertilization-embryo transfer: a three-arm randomized controlled trial. J Psychosom Obstet Gynaecol. 2023 Dec;44(1):2278015. doi: 10.1080/0167482X.2023.2278015. Epub 2023 Dec 6. |
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The participants are not willing to share the data.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 20, 2019 | Apr 23, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| Change of sleeping quality |
The physical condition closely related to stress. The investigators will use Self-Rating Scale of Sleep to measure the sleeping quality of the participants. The total sore ranges from 5 to 50, with higher score reflects better sleep quality. |
| The investigators will measure the socre of sleeping quality at baseline and immediately after intervention ( the duration of intervention is around 1 month). |
| Successful conception rate (%) | The investigators will count the successful conception rate at each arms. | The doctor will test whether it is successfully conceived 4 weeks after the embryo is implanted. The last intervention is on the day of embryo implantation. The investigators will count this 4 weeks after completion of intervention. |