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Development and validation of a questionnaire to assess stress and anxiety during high-risk pregnancy

Development and validation of a questionnaire to assess stress and anxiety during high-risk pregnancy - EVa-SAR

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00035208
Enrollment
322
Registered
2024-11-06
Start date
2024-11-16
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High-risk pregnancy

Interventions

Group 1: At one point, a questionnaire is filled out or an interview is conducted.

Sponsors

Charité — Universitätsmedizin Berlin, Institut für Sozialmedizin, Epidemiologie und Gesundheitsökonomie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Part 1: Content validity: 1. Experts in the field of high-risk pregnancy 2. Signed informed consent form and verbal consent 3. Willingness to participate in the study and to complete the questionnaire 4. Ability to understand and speak German Part 2: Face validity: 1. Consenting pregnant women aged 18 and over 2. Diagnosis of a high-risk pregnancy for at least 2 weeks prior to study inclusion 3. Signed informed consent form and verbal consent 4. Willingness to participate in the study and to complete the questionnaire 5. Ability to understand and speak German Part 3: Internal reliability and construct validity: 1. Consenting pregnant women aged 18 and over 2. Diagnosis of a high-risk pregnancy since at least 2 weeks before study inclusion 3. Signed informed consent form and verbal consent 4. Willingness to participate in the study and to complete the questionnaire 5. Ability to understand and speak German

Exclusion criteria

Exclusion criteria: Part 1: Content validity: Not applicable Part 2: Face validity: 1. Pregnant women with severe cognitive or language impairments that could impair completion of the questionnaire Part 3: Internal reliability and construct validity: 1. Pregnant women with severe cognitive or language impairments that could impair completion of the questionnaire 2. Women who participated in Part 2

Design outcomes

Primary

MeasureTime frame
Content validity, Face validity, Reliability, Construct validity, Convergent validity, Discriminant validity

Countries

Germany

Contacts

Public ContactStephanie Roll

Charité — Universitätsmedizin Berlin, Institut für Sozialmedizin, Epidemiologie und Gesundheitsökonomie

stephanie.roll@charite.de+49 (030) 450 529 023

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026