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

NCT07096427 | Enrolling By Invitation

• 1 other identifier: 2024/36
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

his study is a randomized controlled, single-blind, experimental research aiming to evaluate the effects of education based on Pender's Health Promotion Model-delivered through virtual reality (VR) technology and educational booklets-on healthy lifestyle behaviors in pregnant women. The study will be conducted in two Family Health Centers in Istanbul, and a total of 96 pregnant women will be randomly assigned to three groups: Experimental Group 1 (VR-based education), Experimental Group 2 (education with booklet), and Control Group (routine care). The experimental groups will receive three educational sessions, once a week for three weeks. Following the education sessions, motivational telephone interviews and follow-up assessments will be conducted. Data will be collected using the Healthy Lifestyle Behaviors in Pregnancy Scale (HLBPS), the Depression Anxiety Stress Scale (DASS-21), follow-up forms, and a postpartum evaluation form. The study aims to assess the effectiveness and sustainability of different educational methods on promoting healthy lifestyle behaviors among pregnant women.

Conditions

Pregnancy; Health Behavior; Virtual Reality

Keywords

Pregnancy; Prenatal Education; Health Promotion; Health Promotion Behavior; Virtual Reality

Outcome Measures

Primary Outcomes (1)

• Change in Healthy Lifestyle Behaviors in Pregnancy

  The Healthy Lifestyle Behaviors in Pregnancy Scale is a 29-item, 5-point Likert-type instrument assessing six domains: pregnancy responsibility, hygiene, nutrition, physical activity, travel, and acceptance of pregnancy. Total scores range from 39 to 145, with higher scores reflecting healthier lifestyle behaviors during pregnancy.

  From baseline (12-16 weeks gestation) to follow-up (38 week gestation)

Secondary Outcomes (1)

• From baseline (12-16 weeks gestation) to follow-up (32-36 weeks gestation)

  From baseline (12-16 weeks gestation) to follow-up (38 week gestation)

Study Arms (3)

Virtual Reality Education

EXPERIMENTAL

Participants receive education based on Pender's Health Promotion Model using virtual reality videos. The program includes three weekly sessions, each lasting about 20 minutes.

Behavioral: Virtual Reality-Based Prenatal Education

Booklet-Based Education

EXPERIMENTAL

Participants receive the same educational content through printed booklets over three weekly face-to-face sessions of 20 minutes each.

Behavioral: Booklet-Based Prenatal Education

Routine Care

NO INTERVENTION

Participants receive standard prenatal care provided at the Family Health Center. No additional educational intervention is applied.

Interventions

Virtual Reality-Based Prenatal Education BEHAVIORAL

This intervention involves prenatal education based on Pender's Health Promotion Model delivered using immersive 360-degree virtual reality (VR) videos. The content focuses on healthy lifestyle behaviors during pregnancy, including nutrition, physical activity, stress management, and health responsibility. Participants view the videos via VR headsets in three weekly sessions, each lasting approximately 20 minutes. Motivational follow-up calls are conducted after the sessions.

Virtual Reality Education

Booklet-Based Prenatal Education BEHAVIORAL

This intervention includes prenatal education based on Pender's Health Promotion Model delivered through printed booklets. The educational content is identical to that of the VR group and covers healthy behaviors in pregnancy. The booklets are discussed in three face-to-face sessions, held once per week for three weeks. Each session lasts about 20 minutes. Participants receive motivational follow-up phone calls after the sessions.

Booklet-Based Education

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Eligibility to participate is based on biological sex (female), regardless of gender identity, due to the nature of the study targeting pregnant individuals.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women between 12-16 weeks of gestation
• Primigravida (first pregnancy)
• No chronic disease or health condition affecting lifestyle behaviors
• Able to communicate and give informed consent

You may not qualify if:

• High-risk pregnancies (e.g., gestational diabetes, preeclampsia, multiple pregnancy, threatened preterm labor)
• Existing psychiatric or communication impairments (e.g., language barrier)
• Having previously participated in similar educational programs

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Kagithane 13 Nolu Aile Sağlığı Merkezi

Istanbul, Kagithane, 34408, Turkey (Türkiye)

Location

Related Publications (10)

• 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.

  PMID: 36383473 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 33663418 BACKGROUND

• 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.

  PMID: 29344041 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 32217980 BACKGROUND

• 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.

  PMID: 29713151 BACKGROUND

• 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).

  BACKGROUND

• 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.

  PMID: 26161369 BACKGROUND

• 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.

  PMID: 20035645 BACKGROUND

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants were unaware of the group to which they were assigned (VR, booklet, or routine care). Researchers and outcome assessors were not masked.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: July 31, 2025
• Study Start: May 20, 2025
• Primary Completion: December 20, 2025
• Study Completion: December 30, 2025
• Last Updated: August 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)