Effect of Video Based and Standard Information on Maternal Anxiety Levels and Procedure Decision in Pregnant Woman Offered Amniocentesis and Chorionic Villus Sampling: a 4 Group Prospective Study
| Registry | NCT07876726 |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; non randomized, parallel, masking: none, supportive care |
| Enrollment | 250 (Estimated) |
| Sponsor | Ankara City Hospital Bilkent (Other) |
| Conditions | Maternal Anxiety, Prenatal Diagnosis, Amniocentesis, Chorionic Villus Sampling |
| Interventions | Multilingual Video-Based Patient Education, Standard Verbal Informed Consent (Behavioral) |
| Dates | start 2026-10-09, primary completion 2027-04-30 (estimated), completion 2027-07-30 (estimated), first posted 2026-10-15, last updated 2026-10-21 |
| Locations | 1 site in Turkey (Türkiye) |
Related Papers Related Patents Related Grants Related Experts
All trials for Maternal Anxiety All trials for Prenatal Diagnosis All trials of Multilingual Video-Based Patient Education All trials of Standard Verbal Informed Consent
This prospective study evaluates the impact of video-based patient education compared to standard verbal informed consent on state anxiety levels and procedure acceptance rates in pregnant women undergoing invasive prenatal diagnostic testing (amniocentesis or chorionic villus sampling). Participants are assigned to four groups based on their video preference and procedural recommendation to assess changes in anxiety scores (STAI-S) before and after counseling, as well as final decisions regarding the procedure.
Invasive prenatal diagnostic procedures, such as Amniocentesis and Chorionic Villus Sampling (CVS), are associated with significant maternal anxiety driven by fear of procedural complications, pregnancy loss, and uncertainty regarding fetal health. Standard verbal informed consent processes may sometimes fail to fully address patient concerns due to time constraints or complex medical terminology.
This prospective study aims to investigate whether standardized, multilingual video-based educational material enhances patient comprehension, reduces state anxiety, and influences procedure acceptance rates among women offered invasive prenatal testing.
The study includes four distinct arms/groups based on the intervention type (video-assisted vs. standard consent) and the recommended procedure (amniocentesis vs. CVS). Baseline maternal characteristics, state-trait anxiety levels (STAI-T and STAI-S), and Intolerance of Uncertainty Scale (IUS-27) scores are evaluated at baseline (T0). Post-counseling anxiety levels (STAI-S) and the final decision to undergo or decline the recommended procedure (T1) are subsequently recorded and analyzed across groups.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Group 1: Video Education - Accepted Procedure | Experimental | Behavioral: Multilingual Video-Based Patient Education | Pregnant women who received video-based educational material prior to informed consent and decided to undergo the offered invasive prenatal diagnostic procedure (amniocentesis or CVS). |
| Group 2: Video Education - Declined Procedure | Experimental | Behavioral: Multilingual Video-Based Patient Education | Pregnant women who received video-based educational material prior to informed consent and decided to decline the offered invasive prenatal diagnostic procedure (amniocentesis or CVS). |
| Group 3: Standard Counseling - Accepted Procedure | Active comparator | Behavioral: Standard Verbal Informed Consent | Pregnant women who received standard verbal informed consent and decided to undergo the offered invasive prenatal diagnostic procedure (amniocentesis or CVS). |
| Group 4: Standard Counseling - Declined Procedure | Active comparator | Behavioral: Standard Verbal Informed Consent | Pregnant women who received standard verbal informed consent and decided to decline the offered invasive prenatal diagnostic procedure (amniocentesis or CVS). |
Sex: Female, ages: 18 Years to 45 Years, accepts healthy volunteers
Inclusion Criteria * Presenting to the Perinatology Unit, * Aged between 18 and 45 years, * Having a singleton and live pregnancy, * Recommended for invasive prenatal diagnostic testing due to medical indications, * Proficient in reading, writing, and understanding the Turkish language, * Willing to participate in the study (consenting to informed consent). Exclusion Criteria: * Having a history of psychiatric disorders or depression, * Currently using psychiatric/psychotropic medication, * Having a history of invasive procedures in previous pregnancies, * Having a multiple pregnancy, * Having visual, auditory, or cognitive impairments, * Leaving more than 3 questions unanswered in the data collection tools (scales and forms) or withdrawing/dropping out of the study before completion.
| Facility | City | Country | Status |
|---|---|---|---|
| Ankara Bilkent City Hospital | Ankara, Ankara | Turkey (Türkiye) | Recruiting |