Maternal AnxietyNCT07876726
Effect of Video -Based vs Standard ınformation on Maternal Anxiety and Procedure Decision in Pregnant Woman Offered Amniocentesis or Cvs
A study testing Multilingual Video-Based Patient Education and Standard Verbal Informed Consent in people with Maternal Anxiety and Prenatal Diagnosis, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal Anxiety, Prenatal Diagnosis, Amniocentesis
- What is being tested?
- Multilingual Video-Based Patient Education and Standard Verbal Informed Consent
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Oct 2026to 30 Jul 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Bilkent City Hospital
Ankara, Ankara, 06800
beste taş, md, 5389797766, besteklc50@gmail.com
About this study
Official title: 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
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.
Read the detailed description
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.
- Being tested
- Multilingual Video-Based Patient Education, Standard Verbal Informed Consent
- Keywords
- Video-Based Patient Education, Informed Consent, STAI Score, Prenatal Genetic Testing, Decision Making
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multilingual Video-Based Patient EducationBehavioural
A standardized, multi-language educational video explaining the procedure, risks, benefits, and alternatives of invasive prenatal diagnostic tests.
Standard Verbal Informed ConsentBehavioural
Routine clinical practice involving verbal discussion and standard printed informed consent documents.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Video Education - Accepted Procedure | Experimental | 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). Receives: Behavioral: Multilingual Video-Based Patient Education |
| Group 2: Video Education - Declined Procedure | Experimental | 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). Receives: Behavioral: Multilingual Video-Based Patient Education |
| Group 3: Standard Counseling - Accepted Procedure | Active comparator | Pregnant women who received standard verbal informed consent and decided to undergo the offered invasive prenatal diagnostic procedure (amniocentesis or CVS). Receives: Behavioral: Standard Verbal Informed Consent |
| Group 4: Standard Counseling - Declined Procedure | Active comparator | Pregnant women who received standard verbal informed consent and decided to decline the offered invasive prenatal diagnostic procedure (amniocentesis or CVS). Receives: Behavioral: Standard Verbal Informed Consent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Maternal State Anxiety Level
Assessed using the State-Trait Anxiety Inventory-State (STAI-S) subscale (scores range from 20 to 80, with higher scores indicating higher state anxiety). Measured before and immediately after the educational intervention or standard counseling.
Measured: Immediately before and after counseling on the same day (baseline and post-intervention)
Procedure Acceptance Rate
Percentage of pregnant women who decide to undergo or decline the offered invasive prenatal diagnostic procedure (amniocentesis or CVS) following the counseling session.
Measured: Immediately following the counseling session (Day 1)
Secondary outcomes (4)
Baseline Trait Anxiety Level
Evaluated using the State-Trait Anxiety Inventory-Trait (STAI-T) subscale (scores range from 20 to 80, higher scores indicate greater dispositional anxiety) to assess its baseline influence on maternal decision-making and response to video education.
Measured: Baseline (Day 1, prior to counseling)
Intolerance of Uncertainty Score
Assessed using the Intolerance of Uncertainty Scale (IUS-27) to evaluate baseline individual tolerance to uncertain outcomes and its potential mediating effect on procedure decision and post-counseling state anxiety.
Measured: Baseline (Day 1, prior to counseling)
Impact of Primary Language Video Counseling on Anxiety Reduction
Comparison of post-counseling state anxiety score (STAI-S) changes across patient subgroups receiving video-based education in their primary language (including Turkish, English, and Arabic) versus standard consent procedures.
Measured: Immediately after counseling on the same day (baseline to post-intervention)
Influence of Obstetric History on Anxiety and Decision-Making
Evaluation of the association between baseline state anxiety (STAI-S) and procedure acceptance rates with maternal demographic and obstetric factors, including gestational age, gravidity, parity, prior history of invasive diagnostic procedures, and specific indication for prenatal testing.
Measured: Baseline (Day 1, prior to counseling)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start9 Oct 2026
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A 4-Group Prospective Study
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- beste taş, md, Principal investigator, Ankara Bilkent City Hospital, Department of Obstetrics and Gynecologyelif gül yapar eyi, md professor, Study director, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07876726
- Sponsor's protocol ID
- 1-26-3248
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No