Effectiveness of Gestaverso Virtual Reality Birth Preparation in Women With Previous Negative Birth Experiences (Gestaverso)
Effectiveness of Gestaverso Versus Usual Childbirth Preparation in Pregnant Women With Previous Negative Birth Experiences: A Multicenter Randomized Controlled Trial
A previous negative childbirth experience can increase fear and anxiety about giving birth again. This study aims to determine whether Gestaverso, a virtual reality-based childbirth preparation program, can help reduce fear of childbirth and improve the birth experience in pregnant women who have previously experienced a negative birth.
The study will include 124 pregnant women who have given birth at least once before and report a previous negative childbirth experience. Participants will be randomly assigned to one of two groups.
One group will receive an individualized childbirth preparation session using Gestaverso, a virtual reality program guided by a trained midwife. During the approximately 60-minute session, participants will experience a simulated childbirth journey, practice breathing and relaxation techniques, learn strategies for managing contractions, and become familiar with the hospital environment and different stages of labor. Their birth partner will also be encouraged to participate.
The other group will receive usual childbirth preparation provided by midwives, without virtual reality.
Participants will complete questionnaires about their fear of childbirth before the intervention and their childbirth experience after giving birth. The researchers will compare the results between the two groups to assess whether virtual reality-based childbirth preparation may help women with previous negative birth experiences feel more prepared for childbirth and have a more positive birth experience.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A previous negative childbirth experience may contribute to increased fear and anxiety during subsequent pregnancies. Women who have experienced a distressing or traumatic birth may develop negative expectations about future childbirth, potentially affecting their emotional well-being and confidence in their ability to cope with labor.
Conventional childbirth preparation programs provide information about pregnancy, labor, pain management, and coping strategies. However, women with previous negative birth experiences may benefit from additional approaches that address the emotional aspects of childbirth and help them become familiar with the birth environment in a safe and controlled setting.
Virtual reality (VR) offers an immersive educational experience that allows pregnant women to become familiar with different stages of labor, practice coping strategies, and develop confidence in managing childbirth-related situations. Although VR has been investigated for pain and anxiety management during labor, its potential as a prenatal preparation tool specifically for women with previous negative childbirth experiences remains insufficiently explored.
Gestaverso is an immersive VR-based childbirth preparation program designed to simulate the childbirth journey, from the onset of labor at home to hospital admission, labor progression, and birth. The program combines visual, auditory, tactile, and sensory stimuli with professional guidance from a trained midwife.
This multicenter, randomized controlled trial will compare Gestaverso with usual childbirth preparation provided by midwives. Participants will be randomly allocated to two parallel groups in a 1:1 ratio.
The Gestaverso intervention consists of one individualized 60-minute session, including a 10-minute briefing, approximately 40 minutes of immersive VR simulation, and a 10-minute debriefing. The experience is guided by a midwife certified in Gestaverso training and adapted to the participant's individual needs.
During the simulation, participants will experience different childbirth scenarios, including the onset and progression of contractions at home, the transition to the hospital, admission procedures, and the different stages of labor. They will practice breathing, relaxation, movement, pain management strategies, and communication with healthcare professionals. The birth partner will also be involved in learning supportive techniques.
The control group will receive usual childbirth preparation delivered by midwives through group-based educational sessions, either in person or online. These sessions address third-trimester symptoms, signs of labor, types of birth, contraction management, breathing techniques, and pelvic movement.
The study will be conducted at three hospitals in Spain: HM Puerta del Sur, HM Nuevo Belén, and HM Montepríncipe.
The study aims to determine whether Gestaverso can reduce fear of childbirth and improve the childbirth experience compared with usual childbirth preparation in women with previous negative birth experiences. It will also explore participants' satisfaction with and acceptance of virtual reality as a childbirth preparation tool.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Cayetana Ruiz Zaldibar, PhD
- Phone Number: 695829472
- Email: crzaldibar@ucjc.edu
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Pregnant women aged 18 years or older.
- Pregnant women at or beyond 32 weeks of gestation.
- Having experienced at least one previous childbirth.
- Reporting a previous negative childbirth experience, defined by an affirmative response to the question: "Was there any moment during your previous childbirth that you found distressing or traumatic?"
- Ability to read and understand the language in which the childbirth preparation program is delivered.
- Willingness to participate voluntarily and provide written informed consent.
Exclusion Criteria:
- Women who have never given birth before (primiparous women).
- Previous psychiatric diagnosis or anxiety disorder requiring active treatment.
- Multiple pregnancies, high-risk pregnancies, or obstetric complications that may limit participation.
- Cognitive or sensory impairments that prevent the use of virtual reality.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Gestaverso Virtual Reality Childbirth Preparation
Participants assigned to this arm will receive an individualized 60-minute childbirth preparation session using Gestaverso, an immersive virtual reality program guided by a certified midwife. The session consists of a 10-minute briefing, approximately 40 minutes of immersive simulation, and a 10-minute debriefing. The simulation recreates the childbirth journey, from the onset of labor at home to hospital admission, labor progression, and birth. Participants will practice breathing, relaxation, pelvic movement, non-pharmacological pain management strategies, and communication with healthcare professionals. Their birth partner will also participate in the experience and learn techniques to provide physical and emotional support during labor. |
Virtual Reality-Based Childbirth Preparation (Gestaverso) |
|
Active Comparator: Usual Childbirth Preparation
Participants assigned to this arm will receive usual childbirth preparation provided by midwives through group-based educational sessions, either in person or online, according to their preferences. The program consists of approximately 3 to 4 hours of education covering third-trimester symptoms, signs of labor, types of birth, contraction management, breathing techniques, and pelvic movement. Educational materials, recorded sessions, and support for questions will be available when needed. Participants will not receive virtual reality-based childbirth preparation. |
Control group |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fear of Childbirth Assessed Using the Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ)
Time Frame: During pregnancy, before the intervention (baseline), and after childbirth (postpartum assessment), approximately 6-8 weeks from baseline.
|
The Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ) will be used to assess fear of childbirth. The W-DEQ-A will be administered during pregnancy, before the intervention, to assess anticipatory fear of childbirth, while the W-DEQ-B will be administered after childbirth to assess the emotional experience of giving birth. Each version consists of 33 items scored on a 6-point Likert scale (0-5), with a total score ranging from 0 to 165. Higher scores indicate greater fear of childbirth or a more negative childbirth experience. Positively worded items are reverse-scored before calculating the total score. W-DEQ scores will be compared between the Gestaverso intervention group and the usual childbirth preparation group. |
During pregnancy, before the intervention (baseline), and after childbirth (postpartum assessment), approximately 6-8 weeks from baseline.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Childbirth Experience Assessed Using the Childbirth Experience Questionnaire (CEQ-E)
Time Frame: After childbirth, during the postpartum assessment (approximately 6-8 weeks from baseline).
|
Childbirth experience will be assessed using the Spanish version of the Childbirth Experience Questionnaire (CEQ-E), a validated patient-reported experience measure consisting of 22 items across four domains: own capacity (8 items), professional support (5 items), perceived safety (6 items), and participation (3 items). Nineteen items are scored using a 4-point Likert scale, while three items use a visual analogue scale subsequently converted into four categories. Higher scores indicate a more positive childbirth experience. Childbirth experience scores will be compared between the Gestaverso intervention group and the usual childbirth preparation group. |
After childbirth, during the postpartum assessment (approximately 6-8 weeks from baseline).
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Soriano-Vidal FJ, Oliver-Roig A, Cabrero-Garcia J, Congost-Maestre N, Dencker A, Richart-Martinez M. The Spanish version of the Childbirth Experience Questionnaire (CEQ-E): reliability and validity assessment. BMC Pregnancy Childbirth. 2016 Nov 24;16(1):372. doi: 10.1186/s12884-016-1100-z.
- Roldan-Merino J, Ortega-Cejas CM, Lluch-Canut T, Farres-Tarafa M, Biurrun-Garrido A, Casas I, Castrillo-Perez MI, Vicente-Hernandez MM, Jimenez-Barragan M, Martinez-Mondejar R, Hurtado-Pardos B, Cabrera-Jaime S. Validity and reliability of the Spanish version of the "Wijma Delivery Expectancy/Experience Questionnaire" (W-DEQ-B). PLoS One. 2021 Apr 26;16(4):e0249942. doi: 10.1371/journal.pone.0249942. eCollection 2021.
- Storksen HT, Garthus-Niegel S, Vangen S, Eberhard-Gran M. The impact of previous birth experiences on maternal fear of childbirth. Acta Obstet Gynecol Scand. 2013 Mar;92(3):318-24. doi: 10.1111/aogs.12072.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Gestaverso
- 26.07.2751-GHM (Other Identifier: omité Ético de Investigación con medicamentos de HM Hospitales)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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