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

2026년 9월 23일 업데이트: Fundación de investigación HM

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.

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (추정된)

124

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

여성

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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)

활성 비교기: 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

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Fear of Childbirth Assessed Using the Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ)
기간: 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.

2차 결과 측정

결과 측정
측정값 설명
기간
Childbirth Experience Assessed Using the Childbirth Experience Questionnaire (CEQ-E)
기간: 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).

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 11월 1일

기본 완료 (추정된)

2027년 6월 30일

연구 완료 (추정된)

2027년 7월 1일

연구 등록 날짜

최초 제출

2026년 9월 23일

QC 기준을 충족하는 최초 제출

2026년 9월 23일

처음 게시됨 (실제)

2026년 9월 29일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 29일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 23일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • Gestaverso
  • 26.07.2751-GHM (기타 식별자: omité Ético de Investigación con medicamentos de HM Hospitales)

개별 참가자 데이터(IPD) 계획

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아니요

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아니

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