Effect of 3D Ultrasounds and 3D Printed Models on Maternal and Paternal Fetal Attachment and Anxiety and Depression
| Registry | NCT04540458 |
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| Status | Completed |
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| Phase | Not applicable |
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| Study type | Interventional; randomized, parallel, masking: none, health services research |
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| Enrollment | 288 (Actual) |
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| Sponsor | Creighton University (Other) |
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| Conditions | Maternal-Fetal Relations, Paternal Behavior, Maternal Behavior |
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| Interventions | 3D printed model, Placebo (Other) |
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| Dates | start 2020-02-04, primary completion 2021-07-15, completion 2021-07-15, first posted 2020-09-07, last updated 2022-03-16 |
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| Locations | 1 site in United States |
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Related Papers Related Patents Related Grants Related Experts
All trials for Maternal-Fetal Relations All trials for Paternal Behavior All trials of 3D printed model All trials of Placebo
-Summary
To determine whether 3D models of fetus' face created from 3D ultrasound will increase maternal and paternal attachment, lower stress, anxiety and depression and have improved life-style choices during pregnancy. Half of participants will receive 3D model and half will receive a picture of 3D ultrasound of their baby.
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+Arms and interventions
| Arm | Type | Interventions | Description |
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| 3D printed model | Other | Other: 3D printed model | Mother or Mother/Father is given 3D printed model of fetus' face |
| Placebo | Other | Other: Placebo | Mother or Mother/Father is given printed picture of 3D ultrasound of fetus |
- 3D printed model (Other): Mother or Mother/Father is given 3D printed model of fetus' face
- Placebo (Other): Mother or Mother/Father is given a picture of 3D ultrasound of fetus
+Outcome measures
Primary outcomes
- Maternal Antenatal Attachment Scale (MAAS) [5 minutes]: The MAAS is a 19 item questionnaire measuring maternal-fetal attachment. Each item has five answer choices scored from 1 low attachment to 5 high attachment such that the total score ranges from 19 to 95. The measure also includes two subscales: (1) Quality of Attachment has 10 items with a range of 10-50 and measures the quality of the mother's attachment to her fetus. (2) Time measures the time spent in attachment mode (or intensity of preoccupation) and consists of 8 items for a range of 8 to 40. (for clarity one item included in the total score is not included in either subscale.)
- Paternal Antenatal Attachment Scale (PAAS) [5 minutes]: The PAAS is a 16 item questionnaire measuring paternal-fetal attachment. Each item has five answer choices scored from 1 low attachment to 5 high attachment such that the total score ranges from 19 to 95. The measure also includes two subscales: (1) Quality of Attachment has 10 items with a range of 10-50 and measures the quality of the mother's attachment to her fetus. (2) Time measures the time spent in attachment mode (or intensity of preoccupation) and consists of 8 items for a range of 8 to 40. (for clarity one item included in the total score is not included in either subscale.)
- Maternal anxiety [3 minutes]: 7-question Generalized Anxiety Disorder questionnaire (GAD-7) will be administered
- Paternal depression [3 minutes]: 9-question Patient Health Questionnaire (PHQ-9) will be administered
- Maternal depression [3 minutes]: 9-question Patient Health Questionnaire (PHQ-9) will be administered
- Paternal anxiety [3 minutes]: 7-question Generalized Anxiety Disorder questionnaire (GAD-7) will be administered
- Maternal stress [3 minutes]: 11-question Pregnancy-Related Anxiety Questionnaire-Revised (PRAQ-R2) will be administered.
+Eligibility
Sex: All, ages: 19 Years to 45 Years
Inclusion Criteria:
* Age - Female 19-45 years of age; Male > 19 years of age
* Currently pregnant (< 32 weeks gestation)
* Have normal 20-week ultrasound
Exclusion Criteria:
* Having received more than 3 ultrasounds prior to study
* Medical need for additional ultrasounds
* Multiple fetuses
* > 31 weeks gestation
+Locations (1)
| Facility | City | Country | Status |
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| Creighton University | Omaha, Nebraska | United States | |
+Investigators