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Virtual Reality-Based Health Promotion Education and Healthy Living Behaviors in Pregnant Women

StatusCompleted
PhaseNot applicable
Started2025-04-01
View on ClinicalTrials.gov ↗

Amendment history

2026-09-09
critical
Study Status, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v2
Trial status changed: Enrolling by Invitation → Completed
Primary endpoint(s) modified1 entry, revised
WasChange in Healthy Lifestyle Behaviors in Pregnancy
NowChange in Healthy Lifestyle Behaviors in Pregnancy Scale Total and Subscale Scores
Primary completion confirmed: January 2026 (last estimated December 2025)
Primary completion dateestimated 2025-12-20→confirmed 2026-01-20
Completion dateestimated 2025-12-30→confirmed 2026-02-25
Start date2025-05-20→2025-04-01
Enrollment targetestimated 96→confirmed 102
Study sites1→2
Eligibility criteria+88 characters
Inclusion Criteria: Pregnant women betweenaged 18-35 years Being at 12-16 weeks of gestation at enrollment PrimigravidaBeing (firstprimigravida Having pregnancy) Nono chronic disease or health condition affecting healthy lifestyle behaviors AbleBeing able to communicate and giveprovide informed consent Exclusion Criteria: HighHaving a high-risk pregnanciespregnancy (e.g.at enrollment, including gestational diabetes, preeclampsia, multiple pregnancy, or threatened preterm labor) ExistingHaving a psychiatric disorder or communication impairmentsimpairment (e.g.,that languagecould barrier)prevent [...] [...]
Secondary endpoints1 entry, revised
FromChange baselinein (12Depression, Anxiety, and Stress Scale-1621 weeksSubscale gestation) to follow-up (32-36 weeks gestation)Scores
Study description-1,688 characters
PregnancyThis israndomized acontrolled, criticalopen-label periodstudy that significantly alters a woman's lifestyle and necessitatesevaluated the adoptioneffects of healthytwo behaviors. Duringdelivery pregnancy, engaging in healthy lifestyle behaviors such as attending regular prenatal checkups, avoiding harmful habits, maintaining a balanced diet, performing regular physical activity, and managing stress effectively is of great importance. Neglecting these behaviors can result in serious complic [...] methods for intensiveeducation carebased unit admission. To support behavioral changes during thi [...] [...]
2025-07-31
minor
Study Status, Sponsor/Collaborators, Study Description, Outcome Measures, Eligibility, IPDSharing, References v1
Secondary endpointsdetails revised at 1 of 1 entry
Study description-315 characters
[...] vity, and managing stress effectively is of great importance (Lin et al., 2009; Malakouti et al., 2015). Neglecting these behaviors can result in serious complicat [...] birth weight, and the need for intensive care unit admission (Hamulka et al., 2018). To support behavioral changes during this period, various [...] to facilitate the development of health-promoting behaviors (Mohamadian et al., 2011; Estebsari et al., 2018). The model explains the formation of health behaviors by co [...] ts and barriers, self-efficacy, and interpersonal influences (Yang et al., 2017). The American College of Obstetricians and [...] [...]
Publicationsdetails revised at 10 of 10 entries
2025-07-24
minor
Original filing
This randomized controlled, open-label trial evaluated the effects of education based on Pender's Health Promotion Model, delivered through virtual reality or printed educational booklets, on healthy lifestyle behaviors in pregnant women. The study was conducted at two family health centers in Istanbul, Turkey, between April 2025 and February 2026. A total of 102 primigravida pregnant women at 12-16 weeks of gestation were randomly assigned in equal numbers to a virtual reality education group, a booklet-based education group, or a routine-care control group. Both intervention groups received three weekly educational sessions followed by five monthly motivational interviewing telephone calls, while the control group received routine prenatal care. Healthy lifestyle behaviors and depression, anxiety, and stress symptoms were assessed at baseline and at 36-38 weeks of gestation. Ninety-five participants completed the study and were included in the analyses.
Trial Details
NCT Number NCT07096427
Lead Sponsor Istanbul University - Cerrahpasa
Conditions Pregnancy, Health Behavior
Enrollment 102 participants
Start Date 2025-04-01
Primary Completion 2026-01-20 (estimated)
Study Completion 2026-02-25 (estimated)
Updated on ClinicalTrials.gov 2026-09-18