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PregnancyNCT07096427

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

A study testing Virtual Reality-Based Prenatal Education and Booklet-Based Prenatal Education in people with Pregnancy and Health Behavior, run by Istanbul University - Cerrahpasa at 2 sites in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for
Pregnancy, Health Behavior
What is being tested?
Virtual Reality-Based Prenatal Education and Booklet-Based Prenatal Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
102 participants
Where
2 sitesTurkey (Türkiye)
Study dates
1 Apr 2025to 25 Feb 2026
Phase
Interventional
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 35 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Turkey (Türkiye)2 sites
  • Gençosman Aile Sağlığı Merkezi

    Istanbul, Güngören, 34165

  • Kagithane 13 Nolu Aile Sağlığı Merkezi

    Istanbul, Kagithane, 34408

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the detailed description

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.

Being tested
Virtual Reality-Based Prenatal Education, Booklet-Based Prenatal Education
Keywords
Pregnancy, Prenatal Education, Health Promotion, Health Promotion Behavior, Virtual Reality, Pender's Health Promotion Model
Medical subject headings
Health Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual Reality-Based Prenatal EducationBehavioural

    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 EducationBehavioural

    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.

Study groups in NCT07096427
Study groupRoleWhat they receive
Virtual Reality EducationExperimentalParticipants received education based on Pender's Health Promotion Model through immersive 360-degree virtual reality videos in three weekly sessions. The virtual reality 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.
Receives: Behavioral: Virtual Reality-Based Prenatal Education
Booklet-Based EducationExperimentalParticipants received the same educational content based on Pender's Health Promotion Model through a printed booklet 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.
Receives: Behavioral: Booklet-Based Prenatal Education
Routine CareNo interventionParticipants received routine prenatal care provided at the family health centers. No additional education, motivational interviewing, or interim assessment was provided during the study.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

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

Secondary outcomes (1)
  1. Depression Anxiety Stress Scale-21 Subscale Scores Following the Intervention Period

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2025
  2. Study start1 Apr 2025
  3. Primary completion20 Jan 2026
  4. Study completion25 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study uses a parallel assignment model in which participants are randomly assigned to one of three groups: (1) a virtual reality-based education group, (2) a booklet-based education group, or (3) a routine care control group. All interventions are delivered concurrently, and participants remain in their assigned group throughout the study period.
Masking
None (open label)
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07096427
Sponsor's protocol ID
2024/36
Status last verified
Sep 2026
First submitted
24 Jul 2025
Last updated
18 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be shared because data sharing was not included in the informed consent process.

Publications

  • Estrella-Juarez F, Requena-Mullor M, Garcia-Gonzalez J, Lopez-Villen A, Alarcon-Rodriguez R. Effect of Virtual Reality and Music Therapy on the Physiologic Parameters of Pregnant Women and Fetuses and on Anxiety Levels: A Randomized Controlled Trial. J Midwifery Womens Health. 2023 Jan;68(1):35-43. doi: 10.1111/jmwh.13413. Epub 2022 Nov 16.

    PubMed 36383473
  • Jerald, J. (2015). The VR Book: Human-Centered Design for Virtual Reality. Morgan & Claypool.

  • Permatasari TAE, Rizqiya F, Kusumaningati W, Suryaalamsah II, Hermiwahyoeni Z. The effect of nutrition and reproductive health education of pregnant women in Indonesia using quasi experimental study. BMC Pregnancy Childbirth. 2021 Mar 4;21(1):180. doi: 10.1186/s12884-021-03676-x.

    PubMed 33663418
  • Goodarzi-Khoigani M, Baghiani Moghadam MH, Nadjarzadeh A, Mardanian F, Fallahzadeh H, Mazloomy-Mahmoodabad S. Impact of Nutrition Education in Improving Dietary Pattern During Pregnancy Based on Pender's Health Promotion Model: A Randomized Clinical Trial. Iran J Nurs Midwifery Res. 2018 Jan-Feb;23(1):18-25. doi: 10.4103/ijnmr.IJNMR_198_16.

    PubMed 29344041
  • American College of Obstetricians and Gynecologists. (2023). Nutrition During Pregnancy. Retrieved from https://www.acog.org/womens-health/faqs/nutrition-during-pregnancy.

  • Physical Activity and Exercise During Pregnancy and the Postpartum Period: ACOG Committee Opinion, Number 804. Obstet Gynecol. 2020 Apr;135(4):e178-e188. doi: 10.1097/AOG.0000000000003772.

    PubMed 32217980
  • Estebsari F, Dastoorpoor M, Mostafaei D, Khanjani N, Khalifehkandi ZR, Foroushani AR, Aghababaeian H, Taghdisi MH. Design and implementation of an empowerment model to prevent elder abuse: a randomized controlled trial. Clin Interv Aging. 2018 Apr 17;13:669-679. doi: 10.2147/CIA.S158097. eCollection 2018.

    PubMed 29713151
  • Mohamadian, H., Eftekhar Ardebili, H., Rahimi Foroushani, A., Taghdisi, M. H., & Shojaiezade, D. (2011). Evaluation of Pender's health promotion model for predicting adolescent girls' quality of life. Journal of School of Public Health & Institute of Public Health Research, 8(4).

  • Malakouti J, Sehhati F, Mirghafourvand M, Nahangi R. Relationship between Health Promoting Lifestyle and Perceived Stress in Pregnant Women with Preeclampsia. J Caring Sci. 2015 Jun 1;4(2):155-63. doi: 10.15171/jcs.2015.016. eCollection 2015 Jun.

    PubMed 26161369
  • Lin YH, Tsai EM, Chan TF, Chou FH, Lin YL. Health promoting lifestyles and related factors in pregnant women. Chang Gung Med J. 2009 Nov-Dec;32(6):650-61.

    PubMed 20035645

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Reality-Based Prenatal Education and Booklet-Based Prenatal Education in people with Pregnancy and Health Behavior, run by Istanbul University - Cerrahpasa at 2 sites 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 5 inclusion and 3 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 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

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).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07096427, which also lists 10 linked publications.

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 18 Sep 2026.

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