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NCT Number: NCT07096427

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

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.

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Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Gençosman Aile Sağlığı Merkezi, Istanbul, Güngören, Turkey (Türkiye)

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About this study

This randomized controlled, open-label study evaluated the effects of two delivery methods for education based on Pender's Health Promotion Model 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 eligible primigravida pregnant women at 12-16 weeks of gestation were randomly assigned to three groups, with 34 participants in each group. The first experimental group received three weekly individual education sessions delivered through immersive 360-degree virtual reality videos. The second experimental group received the same educational content through printed booklets in three weekly individual face-to-face sessions. Following the educational sessions, both experimental groups received five monthly motivational interviewing telephone calls. The control group received routine prenatal care without additional education or motivational interviewing.

The Healthy Lifestyle Behaviors in Pregnancy Scale and the Depression Anxiety Stress Scale-21 were administered face-to-face at baseline and by telephone at 36-38 weeks of gestation. The primary outcomes were the total and subscale scores of the Healthy Lifestyle Behaviors in Pregnancy Scale following the intervention period. The secondary outcomes were the depression, anxiety, and stress subscale scores of the Depression Anxiety Stress Scale-21 following the intervention period. These scores were compared among the virtual reality education, booklet-based education, and routine-care control groups.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant women aged 18-35 years
  • Being at 12-16 weeks of gestation at enrollment
  • Being primigravida
  • Having no chronic disease or health condition affecting healthy lifestyle behaviors
  • Being able to communicate and provide informed consent

Exclusion criteria

  • Having a high-risk pregnancy at enrollment, including gestational diabetes, preeclampsia, multiple pregnancy, or threatened preterm labor
  • Having a psychiatric disorder or communication impairment that could prevent participation
  • Having previously participated in a similar educational program

Treatment and study plan

Virtual Reality-Based Prenatal Education

Behavioral

This behavioral intervention consisted of prenatal education based on Pender's Health Promotion Model delivered through immersive 360-degree virtual reality videos. The content focused on healthy lifestyle behaviors during pregnancy, including nutrition, physical activity, stress management, and health responsibility. Participants viewed the videos using virtual reality headsets in three weekly sessions. The video durations were approximately 25, 28, and 12 minutes. Following the educational sessions, participants received five monthly motivational interviewing telephone calls, each lasting approximately 20 minutes.

Booklet-Based Prenatal Education

Behavioral

This behavioral intervention consisted of prenatal education based on Pender's Health Promotion Model delivered through a printed booklet. The educational content was identical to that provided to the virtual reality group and focused on healthy lifestyle behaviors during pregnancy, including nutrition, physical activity, stress management, and health responsibility. The education was delivered in three weekly face-to-face sessions, each lasting approximately 15-30 minutes. Following the educational sessions, participants received five monthly motivational interviewing telephone calls, each lasting approximately 20 minutes.

Primary outcomes

  1. Healthy Lifestyle Behaviors in Pregnancy Scale Total and Subscale Scores Following the Intervention Period

    Time frame: Following the intervention period (36-38 weeks of gestation).

    The Healthy Lifestyle Behaviors in Pregnancy Scale is a 29-item, 5-point Likert-type scale comprising six subscales: pregnancy responsibility (4-20 points), hygiene (4-20 points), nutrition (9-45 points), physical activity (3-15 points), travel (5-25 points), and acceptance of pregnancy (4-20 points). The total score ranges from 29 to 145. Higher total and subscale scores indicate healthier lifestyle behaviors during pregnancy. Following the intervention period, total and subscale scores were compared among the virtual reality-supported education, booklet-supported education, and routine-care groups.

Secondary outcomes

  1. Depression Anxiety Stress Scale-21 Subscale Scores Following the Intervention Period

    Time frame: Following the intervention period (36-38 weeks of gestation).

    The Depression Anxiety Stress Scale-21 is a 21-item self-report instrument comprising three subscales: depression, anxiety, and stress. Each subscale contains seven items rated from 0 to 3, with subscale scores ranging from 0 to 21. Higher scores indicate greater levels of depression, anxiety, or stress symptoms. Following the intervention period, depression, anxiety, and stress subscale scores were compared among the virtual reality-supported education, booklet-supported education, and routine-care groups.

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study title

Effects of Health Promotion Model-Based Education Given to Pregnants With Virtual Reality on Healthy Living Behaviors

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 31, 2025
Registry last updated
Sep 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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