MothersNCT05669937
Validity and Reliability of the Baby Preparation and Worry Scale
An observational study of Mothers, run by Mevlüde Alpaslan Arar at 1 site in Turkey (Türkiye).
Trial summary
Background: Reliable and valid measurement tools are needed to capture key components of prenatal distress, including anxiety and anxiety states that may put women and children at increased risk in the postpartum period. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Mothers
- How many people
- 220 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 1 Oct 2022
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Adult
Study population: The population for this methodological study comprised pregnant women in the third trimester reached online through pregnancy platforms (Instagram, Facebook, pregnancy class WhatsApp groups, etc.).
Who may be able to join
- Women who were married, older than 18 years, at least primary school graduates, in the third trimester of pregnancy and who accepted participation in the study were included.
Who cannot join
- Pregnant women with chronic disease and psychiatric disease history were not included in the research.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Turkish Validity and Reliability of the Baby Preparation and Worry Scale
Background: Reliable and valid measurement tools are needed to capture key components of prenatal distress, including anxiety and anxiety states that may put women and children at increased risk in the postpartum period.
Aim: The aim of this study is to determine the validity and reliability of the Baby Preparation and Worry Scale (Baby-PAWS), by adapting it to Turkish culture.
.
- Conditions
- Mothers
- Keywords
- Infant Preparation, Worry, Mother health, Assessment Tool, Validity and Reliability,
What is being measured
The primary outcome is the main question the study is designed to answer.
"Baby Preparation and Worry Scale (Baby-PAWS)" developed by Erickson et al. to Turkish culture and perform validity and reliability studies to contribute a new scale tool specific to this field to the literature
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2023
- Study start1 Jan 2022
- Primary completion1 Jul 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MothersStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 220 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Mevlüde Alpaslan Arar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mevlüde Alpaslan Arar, Ordu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05669937
- Sponsor's protocol ID
- eylül2
- Status last verified
- Dec 2022
- First submitted
- 30 Nov 2022
- Last updated
- 3 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turkish Validity and Reliability of the Baby Preparation and Worry Scale
- ClinicalTrials.gov ID
- NCT05669937
- Acronym / sponsor ID
- eylül2
- Conditions
- Mothers
- Keywords
- Infant Preparation, Worry, Mother health, Assessment Tool, Validity and Reliability,
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Mevlüde Alpaslan ArarUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 3 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Reliable and valid measurement tools are needed to capture key components of prenatal distress, including anxiety and anxiety states that may put women and children at increased risk in the postpartum period.
Aim: The aim of this study is to determine the validity and reliability of the Baby Preparation and Worry Scale (Baby-PAWS), by adapting it to Turkish culture.
.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- The population for this methodological study comprised pregnant women in the third trimester reached online through pregnancy platforms (Instagram, Facebook, pregnancy class WhatsApp groups, etc.).
Key inclusion criteria (1 listed)
- Women who were married, older than 18 years, at least primary school graduates, in the third trimester of pregnancy and who accepted participation in the study were included.
Key exclusion criteria (1 listed)
- Pregnant women with chronic disease and psychiatric disease history were not included in the research.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
"Baby Preparation and Worry Scale (Baby-PAWS)" developed by Erickson et al. to Turkish culture and perform validity and reliability studies to contribute a new scale tool specific to this field to the literature
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mothers, run by Mevlüde Alpaslan Arar at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
"Baby Preparation and Worry Scale (Baby-PAWS)" developed by Erickson et al. to Turkish culture and perform validity and reliability studies to contribute a new scale tool specific to this field to the literature (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2023.