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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorFundación de investigación HM

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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?"

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Gestaverso

    Behavioral

    Virtual Reality-Based Childbirth Preparation (Gestaverso)

  • Control group

    Behavioral

    Control group

Treatment groups

124 Participants
are divided into 2 treatment groups
Group A: Gestaverso Virtual Reality Childbirth PreparationExperimental treatment 1 intervention
Group B: Usual Childbirth PreparationActive comparator 1 intervention

Trial outcomes

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.

Time frame
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)

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.

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

Other outcomes

Locations

This trial has no locations.

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