Effectiveness of Gestaverso Virtual Reality Birth Preparation in Women With Previous Negative Birth Experiences

NCT07846306 | Not Yet Recruiting

• 2 other identifiers: Gestaverso26.07.2751-GHM
• Study Type: interventional
• Target: 124
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Fear of Childbirth; Childbirth-Related Anxiety

Keywords

Gestaverso; Virtual Reality; Childbirth Preparation; Fear of Childbirth; Childbirth-Related Anxiety; Negative Birth Experience; Traumatic Childbirth; Prenatal Education; Childbirth Experience

Outcome Measures

Primary Outcomes (1)

• Fear of Childbirth Assessed Using the Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ)

  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 Outcomes (1)

• Childbirth Experience Assessed Using the Childbirth Experience Questionnaire (CEQ-E)

  After childbirth, during the postpartum assessment (approximately 6-8 weeks from baseline).

Study Arms (2)

Gestaverso Virtual Reality Childbirth Preparation

EXPERIMENTAL

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.

Behavioral: Gestaverso

Usual Childbirth Preparation

ACTIVE COMPARATOR

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.

Behavioral: Control group

Interventions

Gestaverso BEHAVIORAL

Virtual Reality-Based Childbirth Preparation (Gestaverso)

Gestaverso Virtual Reality Childbirth Preparation

Control group BEHAVIORAL

Control group

Usual Childbirth Preparation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación de investigación HM: lead

Related Publications (3)

• 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.

  PMID: 27884123 RESULT

• 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.

  PMID: 33901208 RESULT

• 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.

  PMID: 23278249 RESULT

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Cayetana Ruiz Zaldibar, PhD

CONTACT

695829472; crzaldibar@ucjc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2026
• First Posted: September 29, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share