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A randomized control trial to investigate whether an informative video before planned external cephalic version reduces maternal anxiety and improves chances of success.
Women with a breech presentation scheduled to undergo an external cephalic version that meet the criteria are recruited in the Emergency Room by offering every woman that is scheduled to undergo an external cephalic version to participate. Women who agree to participate are asked to sign an inform consent, and are randomized to intervention group and control group. In the Emergency Room sonographic data is collected including amniotic fluid index, engaged presenting part, sonographic and clinical estimation of fetal weight, place of the placenta and various angles between the fetus and the bladder (These data are collected for the study). All participants in the intervention group watches an informative video on recruitment. This video describes in detail the expected external cephalic version process.
Before the external cephalic version and an hour after a successful or an unsuccessful external cephalic version the situation-specific anxiety is measured using the State-Trait Anxiety Inventory score (Attached).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. group that watches an informative video | Experimental | All participants in the intervention group watches an informative video on recruitment. This video describes in detail the expected external cephalic version process. |
|
| 2. group that does not watch an informative video | No Intervention | this group do not watch an informative video before recruitment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Video | Other | All participants in the intervention group watches an informative video on recruitment. This video describes in detail the expected external cephalic version process. |
| Measure | Description | Time Frame |
|---|---|---|
| higher success rates. | Comparing the percentage of successful External Cephalic Version (ECV) procedures between patients who watched an informative video about the procedure and those who did not receive this intervention. | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| impact of watching an informative video before external cephalic version on maternal anxiety levels | Assessing anxiety levels using the State-Trait Anxiety Inventory, administered at two time frames - before the External Cephalic Version (ECV) and an hour after - to determine if women who watch an informative video about the procedure experience lower anxiety compared to those who do not. | 4 years |
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Inclusion Criteria:
Exclusion Criteria:
pregnancy
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hila Shalev, Dr | Contact | 972508807380 | hila6070@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Dorit Ravid, Dr | Meir Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meir Medical Center | Recruiting | Kfar Saba | Israel |
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| ID | Term |
|---|---|
| D001946 | Breech Presentation |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D014743 | Videotape Recording |
| ID | Term |
|---|---|
| D013637 | Tape Recording |
| D001296 | Audiovisual Aids |
| D018961 | Educational Technology |
| D013672 | Technology |
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| D013676 |
| Technology, Industry, and Agriculture |
| D013690 | Television |