Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2025-12-25 @ 3:04 AM
NCT ID:
NCT05441033
Eligibility Criteria:
Inclusion Criteria:
* Having basic literacy skills,
* Owning a smartphone and having internet access,
* Having a singleton and viable pregnancy,
* Being between the 27th and 38th weeks of gestation,
* Not having any diagnosed pregnancy-related risks (e.g., preeclampsia, diabetes, placenta previa, oligohydramnios),
* Not having any diagnosed fetal health issues (e.g., fetal anomalies, intrauterine growth restriction),
* Pregnant individuals and their spouses with no current or prior psychiatric diagnoses.
Exclusion Criteria:
* Not living with their spouse,
* Spouse working in shifts,
* Pregnancy via assisted reproductive techniques,
* Currently participating in childbirth education programs,
* Presence of communication difficulties or cognitive impairments in either the pregnant individual or the spouse.
Withdrawal Criteria:
* Participated in the intervention for fewer than 3 nights,
* Unable to use the Fetal Heart Rate Monitoring Device (FHRMD),
* Experiencing premature birth or pregnancy loss,
* Incomplete questionnaire data,
* Voluntary withdrawal from the study by the participant or their spouse. -
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05441033
Study Brief:
Protocol Section:
NCT05441033